Patient
SHOWCASE-GASTRIC-HER2-001 · Algorithm: ALGO-GASTRIC-METASTATIC-1L
Clinical significance of mutations (ESCAT)
Tumor-board context — the engine does not use these tiers to rank tracks
| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|
| BIO-HER2-SOLID | amplification / overexpression — IHC 3+ or (IHC 2+ + ISH amplified, HER2/CEP17 ≥2.0); ~15-20% of gastric/GEJ adenocarcinoma | IA | Molecular evidence option - SRC-CIVIC: Level A (Supports, Sensitivity/Response)
- SRC-CIVIC: Level B (Supports, Sensitivity/Response)
| HER2-positive gastric/GEJ adenocarcinoma (~15-20%): trastuzumab + chemotherapy is standard 1L (ToGA Bang Lancet 2010 — mOS 13.8 vs 11.1 mo, HR 0.74). Pembrolizumab + trastuzumab + chemo is FDA-approved 1L for HER2-positive PD-L1 CPS ≥1 metastatic gastric/GEJ disease per SRC-NCCN-GASTRIC-2025, SRC-ESMO-GASTRIC-2024 (KEYNOTE-811). Trastuzumab deruxtecan (T-DXd) is FDA-approved 2L+ for HER2-positive (IHC 3+ or 2+) advanced gastric/GEJ adenocarcinoma based on DESTINY-Gastric01 (Shitara NEJM 2020 — ORR 51% vs 14% with chemotherapy). | trastuzumab + fluoropyrimidine + platinum (1L per SRC-NCCN-GASTRIC-2025, SRC-ESMO-GASTRIC-2024)
pembrolizumab + trastuzumab + fluoropyrimidine + platinum (1L HER2+ PD-L1 CPS ≥1 per SRC-NCCN-GASTRIC-2025)
trastuzumab deruxtecan (2L+ post-trastuzumab progression per SRC-NCCN-GASTRIC-2025) | - SRC-NCCN-GASTRIC-2025
- SRC-ESMO-GASTRIC-2024
|
| Biomarker | Status |
|---|
| PD-L1 CPS | Not in KB — ask clinician to verify |
| MSI | Not in KB — ask clinician to verify |
| CLDN18.2 | Excluded (negative) |
Primary current-line option
- Indication
- IND-GASTRIC-METASTATIC-1L-HER2-TOGA
- Regimen
- Trastuzumab + capecitabine + cisplatin (TOGA / KEYNOTE-811)
- Drugs + NSZU
- Trastuzumab (DRUG-TRASTUZUMAB) 8 mg/kg IV loading then 6 mg/kg q3w · IV day 1 every 21d · IV ✓ NSZU covered
- Capecitabine (DRUG-CAPECITABINE) 1000 mg/m² PO BID days 1-14 · PO days 1-14 · PO ✓ NSZU covered
- Cisplatin (DRUG-CISPLATIN) 80 mg/m² · IV day 1 q3w · IV ⚠ NSZU — not for this indication
- Reason
- Primary current-line option selected by ALGO-GASTRIC-METASTATIC-1L at step 1; branch-driving red flag: RF-GASTRIC-HIGH-RISK-BIOLOGY.
Other current-line alternatives (4 tracks)
Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
- Indication
- IND-GASTRIC-OLIGOMET-SYSTEMIC-PLUS-LOCAL
- Regimen
- FLOT
- Drugs + NSZU
- Docetaxel (DRUG-DOCETAXEL) 50 mg/m² · IV over 1h, day 1 of 14-day cycle · IV ✓ NSZU covered
- Oxaliplatin (DRUG-OXALIPLATIN) 85 mg/m² · IV over 2h, day 1 · IV ✓ NSZU covered
- Leucovorin (DRUG-LEUCOVORIN) 200 mg/m² · IV over 30 min, day 1 (concurrent with oxaliplatin) · IV ⚠ NSZU — not for this indication
- 5-Fluorouracil (DRUG-5-FLUOROURACIL) 2600 mg/m² CIV over 24h · Day 1, continuous infusion via ambulatory pump · IV ✓ NSZU covered
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-GASTRIC-METASTATIC-1L-CLDN18-2-ZOLBETUXIMAB
- Regimen
- Zolbetuximab + mFOLFOX6 (SPOTLIGHT) — 1L CLDN18.2-positive HER2-negative gastric/GEJ
- Drugs + NSZU
- Zolbetuximab (DRUG-ZOLBETUXIMAB) Loading 800 mg/m² IV cycle 1 day 1; maintenance 600 mg/m² IV q2w · IV q2w (with mFOLFOX6 backbone) · IV ✗ Not registered in UA
- Oxaliplatin (DRUG-OXALIPLATIN) 85 mg/m² IV day 1 · IV day 1 q2w · IV ✓ NSZU covered
- Leucovorin (DRUG-LEUCOVORIN) 400 mg/m² IV day 1 · IV day 1 q2w · IV ⚠ NSZU — not for this indication
- 5-Fluorouracil (DRUG-5-FLUOROURACIL) 400 mg/m² IV bolus day 1, then 2400 mg/m² IV continuous infusion over 46 h · IV q2w · IV ✓ NSZU covered
- Supportive care
- SUP-ANTIEMETIC-PREMED
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-GASTRIC-METASTATIC-1L-FGFR2B-BEMARITUZUMAB
- Regimen
- Bemarituzumab + mFOLFOX6 (FORTITUDE-101) — 1L FGFR2b-overexpressing HER2-non-positive gastric/GEJ
- Drugs + NSZU
- Bemarituzumab (DRUG-BEMARITUZUMAB) 15 mg/kg IV q2w; cycle 1 day 8 additional 7.5 mg/kg loading dose (FORTITUDE-101 protocol) · IV q2w (with mFOLFOX6 backbone) + cycle 1 day 8 booster dose · IV ✗ Not registered in UA
- Oxaliplatin (DRUG-OXALIPLATIN) 85 mg/m² IV day 1 · IV day 1 q2w · IV ✓ NSZU covered
- Leucovorin (DRUG-LEUCOVORIN) 400 mg/m² IV day 1 · IV day 1 q2w · IV ⚠ NSZU — not for this indication
- 5-Fluorouracil (DRUG-5-FLUOROURACIL) 400 mg/m² IV bolus day 1, then 2400 mg/m² IV continuous infusion over 46 h · IV q2w · IV ✓ NSZU covered
- Reason
- Current-line alternative presented for HCP consideration
- Indication
- IND-GASTRIC-METASTATIC-1L-PDL1-CHEMO-ICI
- Regimen
- FOLFOX + Nivolumab
- Drugs + NSZU
- Oxaliplatin (DRUG-OXALIPLATIN) 85 mg/m² · IV day 1 every 14d · IV ✓ NSZU covered
- Leucovorin (DRUG-LEUCOVORIN) 400 mg/m² · IV day 1 · IV ⚠ NSZU — not for this indication
- 5-Fluorouracil (DRUG-5-FLUOROURACIL) 400 mg/m² IV bolus + 2400 mg/m² CIV over 46h · Day 1 bolus, day 1-2 CIV · IV ✓ NSZU covered
- Nivolumab (DRUG-NIVOLUMAB) 360 mg IV q3w (CheckMate-649 primary protocol; FDA-approved flat-dose alternatives 240 mg IV q2w or 480 mg IV q4w) · Primary: 360 mg q3w aligned with XELOX 21-d cycle. Alternatives: 240 mg q2w aligned with FOLFOX 14-d cycle (day 1) or 480 mg q4w (every other FOLFOX cycle) · IV ⚠ NSZU — not for this indication
- Hard contraindications
- CI-PEMBROLIZUMAB-AUTOIMMUNE
- Reason
- Current-line alternative presented for HCP consideration
Why this branch was chosen
Triggers from the patient profile that fired and drove the chosen branch.
Step 1 → branch IND-GASTRIC-METASTATIC-1L-HER2-TOGA
- RF-GASTRIC-HIGH-RISK-BIOLOGY ★ winner: Treatment-defining biomarkers in metastatic gastric/GEJ adenocarcinoma: HER2+ (IHC 3+ OR 2+/ISH+) → trastuzumab+chemo TOGA / T-DXd 2L+; CLDN18.2+ (≥75% of tumor cells with 2+ membranous staining) → zolbetuximab+chemo SPOTLIGHT/GLOW; MSI-H → pembrolizumab mono; EBV+ subtype (TCGA molecular class) — distinct biology, ICI-favorable.
SRC-NCCN-GASTRIC-2025SRC-ESMO-GASTRIC-2024
Pre-treatment investigations
Investigations before treatment start · critical / standard / desired · merged across tracks
| ID | Name | Priority | Category | Where to order | Needed for |
|---|
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | aggressive |
| TEST-CMP | Comprehensive Metabolic Panel | Critical | lab | — | aggressive |
| TEST-CT-CHEST-ABDOMEN-PELVIS | CT chest + abdomen + pelvis with IV contrast | Critical | imaging | — | all tracks |
| TEST-LFT | Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin) | Critical | lab | — | aggressive |
| TEST-MSI-PCR-OR-NGS | MSI status by PCR or NGS | Critical | histology | CSD Lab: M065
CSD Lab ✓ (code TBC) | all tracks |
| TEST-HER2-IHC-ISH-IF-RAS-WT | HER2 IHC + reflex ISH (gastric scoring criteria) | Standard | histology | CSD Lab ✓ (code TBC) | all tracks |
| TEST-NGS-COMPREHENSIVE | Comprehensive NGS tumor panel (DNA + RNA, ≥300 genes) | Desired | histology | CSD Lab: M065 | desired (aggressive) |
Red flags — PRO / CONTRA aggressive
PRO-AGGRESSIVE
Triggers that push toward the aggressive track
- CLDN18.2 expression positive (≥75% of tumor cells with 2+/3+ membranous staining on VENTANA CLDN18 (43-14A) RxDx) in HER2-negative metastatic / unresectable gastric or GEJ adenocarcinoma — eligibility for zolbetuximab + fluoropyrimidine/oxaliplatin 1L (SPOTLIGHT mFOLFOX6 mOS 18.2 vs 15.5 mo HR 0.75; GLOW CAPOX mOS 14.4 vs 12.2 mo HR 0.77). Treatment-defining for the ~38% of HER2-negative gastric cohort. Hierarchy: HER2+ trastuzumab supersedes; MSI-H pembrolizumab supersedes; otherwise CLDN18.2+ → zolbetuximab.
RF-GASTRIC-CLDN18-2-ACTIONABLE
- Surgical/endoscopic emergency in gastric/GEJ adenocarcinoma: massive upper-GI bleed requiring transfusion, gastric outlet obstruction with intolerance of oral intake, or perforation. Mandates urgent endoscopic / surgical / interventional management BEFORE systemic therapy initiation.
RF-GASTRIC-EMERGENCY-BLEED-OBSTRUCTION
- Treatment-defining biomarkers in metastatic gastric/GEJ adenocarcinoma: HER2+ (IHC 3+ OR 2+/ISH+) → trastuzumab+chemo TOGA / T-DXd 2L+; CLDN18.2+ (≥75% of tumor cells with 2+ membranous staining) → zolbetuximab+chemo SPOTLIGHT/GLOW; MSI-H → pembrolizumab mono; EBV+ subtype (TCGA molecular class) — distinct biology, ICI-favorable.
RF-GASTRIC-HIGH-RISK-BIOLOGY
- Oligometastatic esophagogastric adenocarcinoma per OMEC-1 (OligoMetastatic Esophagogastric Cancer) European Delphi consensus (Kroese et al., Eur J Cancer 2023, PMID 36947929). Defined as ≤3 distant metastatic lesions amenable to local therapy in a patient with controllable primary disease and ECOG 0-1 fitness. Excluded scenarios: peritoneal carcinomatosis, leptomeningeal disease, >3 brain metastases. RENAISSANCE / AIO-FLOT5 trial (NCT02578368) eligibility narrower: ≤1 incurable organ-system involvement, no ascites, ≤1 retroperitoneal LN station — uses FLOT chemo ± surgical resection (gastrectomy/oesophagectomy + metastasectomy). Triggers MDT consideration of metastasis-directed local therapy (metastasectomy or SBRT) added to systemic chemo, and registration on RENAISSANCE-pattern trials where available.
RF-OLIGOMET-DEFINITION
CONTRA-AGGRESSIVE
Hard contraindications to escalation
What NOT to do
Explicit prohibitive rules, each grounded in a regimen / supportive care / contraindication entity
Aggressive plan (IND-GASTRIC-METASTATIC-1L-HER2-TOGA)
- Do NOT use without baseline LVEF — trastuzumab cardiotoxic (q3-mo echo monitoring)
- Do NOT combine with anthracycline (cumulative cardiotoxicity)
- Do NOT initiate during ongoing GI bleed / obstruction
Aggressive plan (IND-GASTRIC-OLIGOMET-SYSTEMIC-PLUS-LOCAL)
- Do NOT offer surgical metastasectomy without 4 cycles induction systemic chemo first (RENAISSANCE design requires response demonstration)
- Do NOT include peritoneal carcinomatosis, leptomeningeal disease, or >3 brain mets — these are explicit OMEC-1 exclusions
- Do NOT proceed without MDT review (medical onc + surgical onc + radiation onc)
- Do NOT initiate during ongoing GI bleed / obstruction — emergency management first (RF-GASTRIC-EMERGENCY-BLEED-OBSTRUCTION)
- Do NOT use in HER2-positive disease — route via dedicated HER2 trastuzumab + chemo track
Aggressive plan (IND-GASTRIC-METASTATIC-1L-CLDN18-2-ZOLBETUXIMAB)
- Do not start zolbetuximab without confirmed CLDN18.2 ≥75% 2+/3+ by VENTANA RxDx — outside this range benefit is not proven.
- Do not prescribe zolbetuximab in HER2+ patients — TOGA trastuzumab+chemo takes priority.
- Do not prescribe zolbetuximab in MSI-H patients 1L — pembrolizumab (KEYNOTE-859) takes preference.
- Do not start without triplet antiemetic prophylaxis (5-HT3 + NK1-RA + dex) for cycle 1 — nausea/vomiting severe without it.
- Do not combine with ipilimumab/ICI outside of trials — combination safety unknown.
- Do not confirm the plan without funding pathway — zolbetuximab not registered in UA.
Aggressive plan (IND-GASTRIC-METASTATIC-1L-FGFR2B-BEMARITUZUMAB)
- Do not start bemarituzumab without confirmed FGFR2b IHC 2+/3+ ≥10% by validated IIIb-isoform-selective antibody — outside this range benefit is not proven.
- Do not use pan-FGFR2 IHC instead of FGFR2b-selective — IIIb isoform is the target; pan-FGFR2 does not differentiate isoforms.
- Do not prescribe in HER2+ patients — TOGA trastuzumab+chemo takes priority.
- Do not prescribe in MSI-H patients — pembrolizumab (KEYNOTE-859) takes preference.
- Do not start without baseline ophthalmology exam + serial monitoring plan — corneal events ~70% any-grade, ~25% grade ≥3.
- Do not confirm the plan without funding pathway — bemarituzumab not registered; access via named-patient / clinical-trial only.
- Do not combine with other FGFR-selective inhibitors or CLDN18.2-targeted therapy outside trials.
Standard plan (IND-GASTRIC-METASTATIC-1L-PDL1-CHEMO-ICI)
- Do NOT use without HER2 testing — HER2+ patients get trastuzumab+chemo instead
- Do NOT continue through Grade 3+ irAE without permanent ICI discontinuation consideration
- Do NOT initiate during ongoing GI bleed / obstruction
Timeline
Treatment timeline — derived from regimen + monitoring schedule
Aggressive plan
Induction · Trastuzumab + capecitabine + cisplatin (TOGA / KEYNOTE-811)
21-day cycles × Until progression / unacceptable toxicity (chemo backbone often capped at 6-8 cycles, trastuzumab continues mono)
Aggressive plan
Induction · FLOT
14-day cycles × 8 cycles total in perioperative use (4 pre-op + 4 post-op per FLOT4 / Al-Batran 2019); regimen not used as ongoing systemic therapy beyond periop
Aggressive plan
Induction · Zolbetuximab + mFOLFOX6 (SPOTLIGHT) — 1L CLDN18.2-positive HER2-negative gastric/GEJ
14-day cycles × Until progression / unacceptable toxicity (oxaliplatin commonly capped at 8-12 cycles for cumulative neuropathy; zolbetuximab + 5-FU/LV maintenance continues)
Aggressive plan
Induction · Bemarituzumab + mFOLFOX6 (FORTITUDE-101) — 1L FGFR2b-overexpressing HER2-non-positive gastric/GEJ
14-day cycles × Until progression / unacceptable toxicity (oxaliplatin commonly capped at 8-12 cycles for cumulative neuropathy; bemarituzumab + 5-FU/LV maintenance continues; FORTITUDE-101 protocol allows oxaliplatin discontinuation per investigator with bemarituzumab + 5-FU/LV continued)
Standard plan
Induction · FOLFOX + Nivolumab
14-day cycles × Until progression / unacceptable toxicity (chemo backbone capped at ~12 cycles in some protocols; nivo continues mono until 2 years)
MDT brief
Discussion questions (4, 0 blocking)
OQ-LDH-CURRENT
What is the current LDH? Marker of tumor burden and transformation.
LDH is part of the prognostic indices of indolent lymphomas.
→ hematologist
OQ-BIOMARKER-CLDN18-2
What is the status of Claudin-18.2 expression (CLDN18.2) (BIO-CLDN18-2)? It is required by track(s): IND-GASTRIC-METASTATIC-1L-CLDN18-2-ZOLBETUXIMAB. Expected value: positive — ≥75% of tumor cells with 2+/3+ membranous staining (VENTANA CLDN18 (43-14A) RxDx).
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ pathologist
OQ-BIOMARKER-FGFR2B-IHC
What is the status of FGFR2b protein expression by IHC (membranous staining) (BIO-FGFR2B-IHC)? It is required by track(s): IND-GASTRIC-METASTATIC-1L-FGFR2B-BEMARITUZUMAB. Expected value: FGFR2b 2+/3+ membranous staining in ≥10% of tumor cells (FIGHT / FORTITUDE-101 threshold).
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ pathologist
OQ-BIOMARKER-PDL1-CPS
What is the status of PD-L1 Combined Positive Score (CPS) (BIO-PDL1-CPS)? It is required by track(s): IND-GASTRIC-METASTATIC-1L-PDL1-CHEMO-ICI. Expected value: CPS ≥1.
A treatment-track biomarker requirement is missing from the patient profile; the MDT should verify the test result, method, specimen, and date before relying on this option.
→ pathologist
MDT talk tree (5 steps)
| # | Owner | Topic | Action |
|---|
| 1 | hematologist | Staging / disease burden | What is the current LDH? Marker of tumor burden and transformation. |
| 2 | pathologist | Biomarker status | What is the status of Claudin-18.2 expression (CLDN18.2) (BIO-CLDN18-2)? It is required by track(s): IND-GASTRIC-METASTATIC-1L-CLDN18-2-ZOLBETUXIMAB. Expected value: positive — ≥75% of tumor cells with 2+/3+ membranous staining (VENTANA CLDN18 (43-14A) RxDx). |
| 3 | pathologist | Biomarker status | What is the status of FGFR2b protein expression by IHC (membranous staining) (BIO-FGFR2B-IHC)? It is required by track(s): IND-GASTRIC-METASTATIC-1L-FGFR2B-BEMARITUZUMAB. Expected value: FGFR2b 2+/3+ membranous staining in ≥10% of tumor cells (FIGHT / FORTITUDE-101 threshold). |
| 4 | pathologist | Biomarker status | What is the status of PD-L1 Combined Positive Score (CPS) (BIO-PDL1-CPS)? It is required by track(s): IND-GASTRIC-METASTATIC-1L-PDL1-CHEMO-ICI. Expected value: CPS ≥1. |
| 5 | clinical_pharmacist | Specialist review | Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication. |
Skills (recommended) — for consideration (1)
Data quality
Usable with caveats. No critical default-track gap was found, but the MDT should review the listed caveats before final sign-off.
- Biomarker coverage: 1/4 known (25%), 3 missing, 0 default-track gaps
- Unevaluated RedFlags: RF-ACTIVE-AUTOIMMUNE-DISEASE-ICI-RISK, RF-BREAST-CDH1-LOBULAR-CANDIDATE, RF-GASTRIC-CLDN18-2-ACTIONABLE, RF-GASTRIC-EMERGENCY-BLEED-OBSTRUCTION, RF-GASTRIC-FRAILTY-AGE, RF-GASTRIC-HIGH-RISK-BIOLOGY, RF-GASTRIC-INFECTION-SCREENING, RF-GASTRIC-PDL1-CPS-1-PLUS, RF-GASTRIC-TRANSFORMATION-PROGRESSION, RF-OLIGOMET-DEFINITION
| Missing biomarker | Label | MDT owner | Default track | Required by | Next action |
|---|
BIO-CLDN18-2 | Claudin-18.2 expression (CLDN18.2) | pathologist | no | IND-GASTRIC-METASTATIC-1L-CLDN18-2-ZOLBETUXIMAB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: positive — ≥75% of tumor cells with 2+/3+ membranous staining (VENTANA CLDN18 (43-14A) RxDx) |
BIO-FGFR2B-IHC | FGFR2b protein expression by IHC (membranous staining) | pathologist | no | IND-GASTRIC-METASTATIC-1L-FGFR2B-BEMARITUZUMAB | Verify result, method, specimen, and report date before sign-off. Expected/constraint: FGFR2b 2+/3+ membranous staining in ≥10% of tumor cells (FIGHT / FORTITUDE-101 threshold) |
BIO-PDL1-CPS | PD-L1 Combined Positive Score (CPS) | pathologist | no | IND-GASTRIC-METASTATIC-1L-PDL1-CHEMO-ICI | Verify result, method, specimen, and report date before sign-off. Expected/constraint: CPS ≥1 |
Technical MDT skill metadata (1/16 activated in this plan)
All registered virtual specialists. ✓ — activated for this case; ○ — not activated (available for other clinical scenarios).
| Specialist | skill_id | Version | Last reviewed | Sign-offs | Domain |
|---|
| Cellular therapy specialist (CAR-T) | cellular_therapy_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
| Clinical pharmacist | clinical_pharmacist | v0.1.0 | 2026-04-25 | 0 | clinical_pharmacy |
| Hematologist / oncohematologist | hematologist | v0.1.0 | 2026-04-25 | 0 | hematology_oncology |
| Hematopathologist (lymphoma / leukemia / myeloma) | hematopathologist | v0.1.0 | 2026-04-25 | 0 | hematopathology |
| Infectious disease / hepatology | infectious_disease_hepatology | v0.1.0 | 2026-04-25 | 0 | infectious_diseases |
| Medical oncologist (solid-tumor chemotherapist) | medical_oncologist | v0.1.0 | 2026-04-25 | 0 | solid_oncology |
| Molecular geneticist / molecular oncologist | molecular_geneticist | v0.1.0 | 2026-04-25 | 0 | molecular_oncology |
| Palliative care | palliative_care | v0.1.0 | 2026-04-25 | 0 | palliative_care |
| Pathologist (general) | pathologist | v0.1.0 | 2026-04-25 | 0 | pathology |
| Primary care / family physician | primary_care | v0.1.0 | 2026-04-25 | 0 | primary_care |
| Psycho-oncologist | psychologist | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Radiation oncologist | radiation_oncologist | v0.1.0 | 2026-04-25 | 0 | radiation_oncology |
| Radiologist | radiologist | v0.1.0 | 2026-04-25 | 0 | diagnostic_imaging |
| Social worker / case manager | social_worker_case_manager | v0.1.0 | 2026-04-25 | 0 | psychosocial |
| Surgical oncologist | surgical_oncologist | v0.1.0 | 2026-04-25 | 0 | surgical_oncology |
| Transplant specialist (BMT) | transplant_specialist | v0.1.0 | 2026-04-25 | 0 | cellular_therapy |
Sources cited
- SRC-CHECKMATE-649-JANJIGIAN-2022: First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial (2021)
- SRC-ESMO-GASTRIC-2024: ESMO Gastric Cancer (2024)
- SRC-FORTITUDE-101: Bemarituzumab (BEMA) plus chemotherapy for advanced or metastatic FGFR2b-overexpressing gastric or gastroesophageal junction cancer (G/GEJC): FORTITUDE-101 phase 3 study results ()
- SRC-NCCN-GASTRIC-2025: NCCN Gastric Cancer (v.3.2025)
- SRC-OMEC-1-KROESE-2023: Definition, diagnosis and treatment of oligometastatic oesophagogastric cancer: A Delphi consensus study in Europe (2023)
- SRC-RENAISSANCE-AIO-FLOT5: The RENAISSANCE (AIO-FLOT5) trial: effect of chemotherapy alone vs. chemotherapy followed by surgical resection on survival and quality of life in patients with limited-metastatic adenocarcinoma of the stomach or esophagogastric junction - a phase III trial of the German AIO/CAO-V/CAOGI (2017)
Experimental options (clinical trials)
Third plan track — open-enrollment trials from ClinicalTrials.gov. Render-time metadata; engine selection is not affected by this block (CHARTER §8.3). Last synced: 2026-05-13.
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|
| NCT06510010 | Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer | PHASE2 | RECRUITING | — | Single country | |
| NCT05640609 | Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer | PHASE1 / PHASE2 | RECRUITING | — | Surrogate endpoint only Single country | |
| NCT06808971 | Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC/GEJ | PHASE2 | RECRUITING | — | Surrogate endpoint only Single country | |
| NCT06266299 | A Study of KK2269 in Adult Participants With Solid Tumors | PHASE1 | RECRUITING | — | Phase 1 only | |
| NCT07284186 | First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | — | Phase 1 only Single country | |
| NCT05644431 | GastrOesophageal Tumor, Immune Microenvionnment (GOTIM) | N/A | RECRUITING | — | Single country | |
| NCT05739045 | Nivolumab Combined With SOX Used in the Perioperative Treatment | PHASE2 | RECRUITING | — | Small N (<50) Surrogate endpoint only Single country | |
| NCT06047379 | Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis | PHASE1 / PHASE2 | RECRUITING | — | Surrogate endpoint only Single country | |
| NCT06925243 | Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma | PHASE3 | RECRUITING | — | Single country | |
| NCT07353684 | Adebrelimab Plus Apatinib Combined With SOX Regimen as Conversion Therapy for Gastric Cancer | PHASE2 | RECRUITING | — | Small N (<50) Single country | |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
Option availability in Ukraine
Per-track UA registration · NSZU · cost · access pathway. Render-time metadata; engine selection does not depend on these fields (CHARTER §8.3).
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|
| Aggressive plan Trastuzumab + capecitabine + cisplatin (TOGA / KEYNOTE-811) (REG-TRASTUZUMAB-CHEMO-TOGA) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan FLOT (REG-FLOT) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Aggressive plan Zolbetuximab + mFOLFOX6 (SPOTLIGHT) — 1L CLDN18.2-positive HER2-negative gastric/GEJ (REG-ZOLBETUXIMAB-CHEMO) 1/4 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Aggressive plan Bemarituzumab + mFOLFOX6 (FORTITUDE-101) — 1L FGFR2b-overexpressing HER2-non-positive gastric/GEJ (REG-BEMARITUZUMAB-MFOLFOX6) 1/4 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Standard plan FOLFOX + Nivolumab (REG-FOLFOX-NIVO) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT06510010 Perioperative Oxaliplatin With S-1 Combined H. Pylori Eradication in the Management of Locally Advanced Gastric Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05640609 Capeox Regimen Combined With Sintilimab and Bevacizumab for Gastric Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06808971 Adebrelimab Combined With Nab-paclitaxel, Oxaliplatin and Tegafur (AOS) for Perioperative Treatment of Locally Advanced Resectable GC/GEJ No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06266299 A Study of KK2269 in Adult Participants With Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07284186 First-in-Human Study of PLX-61639 in Locally Advanced or Metastatic Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05644431 GastrOesophageal Tumor, Immune Microenvionnment (GOTIM) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05739045 Nivolumab Combined With SOX Used in the Perioperative Treatment No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06047379 Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06925243 Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07353684 Adebrelimab Plus Apatinib Combined With SOX Regimen as Conversion Therapy for Gastric Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-13.