OpenOnco · DIS-GASTRIC · Actionable biomarker present
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OpenOnco · Treatment Plan
Treatment plan — Gastric and gastroesophageal junction adenocarcinoma
PLAN-VAR-GASTRIC-BIOMARK-V1 · v1 · 2026-05-12
Patient
VAR-GASTRIC-BIOMARK · Algorithm: ALGO-GASTRIC-METASTATIC-1L
DiagnosisGastric and gastroesophageal junction adenocarcinoma
MOH / ICD-10C16
ICD-O-38140/3; C16

Clinical significance of mutations (ESCAT)

Tumor-board context — the engine does not use these tiers to rank tracks
✅ Covered biomarkers (matched in KB)
BiomarkerVariantESCATEvidenceClinical significanceDrugsSources
No clinically actionable variants matched in this profile.
⚠️ Not included in plan
BiomarkerStatus
BIO-CLDN18-2BIO definition in KB; no ESCAT BMA entry — verify with clinician

Primary current-line option

Standard plan
★ DEFAULT
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
Primary current-line option selected by ALGO-GASTRIC-METASTATIC-1L at step 3.

Other current-line alternatives (3 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
Aggressive plan
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
Aggressive plan
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
Current-line alternative presented for HCP consideration
Aggressive plan
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

Pre-treatment investigations

Investigations before treatment start · critical / standard / desired · merged across tracks
IDNamePriorityCategoryWhere to orderNeeded for
TEST-CBCComplete Blood Count with DifferentialCriticallabaggressive
TEST-CMPComprehensive Metabolic PanelCriticallabaggressive
TEST-CT-CHEST-ABDOMEN-PELVISCT chest + abdomen + pelvis with IV contrastCriticalimagingall tracks
TEST-LFTLiver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)Criticallabaggressive
TEST-MSI-PCR-OR-NGSMSI status by PCR or NGSCriticalhistologyCSD Lab: M065
CSD Lab ✓ (code TBC)
all tracks
TEST-HER2-IHC-ISH-IF-RAS-WTHER2 IHC + reflex ISH (gastric scoring criteria)StandardhistologyCSD Lab ✓ (code TBC)all tracks
TEST-NGS-COMPREHENSIVEComprehensive NGS tumor panel (DNA + RNA, ≥300 genes)DesiredhistologyCSD Lab: M065desired (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
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
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-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-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.

Timeline

Treatment timeline — derived from regimen + monitoring schedule

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)

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 · 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 · 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)

MDT brief

Discussion questions (3, 1 blocking)

MDT talk tree (4 steps)

#OwnerTopicAction
1pathologistBiomarker status BLOCKINGWhat 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.
2hematologistStaging / disease burden What is the current LDH? Marker of tumor burden and transformation.
3pathologistBiomarker status What is the status of HER2 status (solid tumors — gastric/GEJ/CRC scoring) (BIO-HER2-SOLID)? It is required by track(s): IND-GASTRIC-METASTATIC-1L-HER2-TOGA. Expected value: positive (IHC 3+ OR IHC 2+/ISH+).
4clinical_pharmacistSpecialist review Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

Skills (recommended) — for consideration (1)

  • Clinical pharmacist recommended
    Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.

Data quality

Incomplete for default-track review. Default-track review is incomplete until required biomarker gaps are resolved.
  • Biomarker coverage: 1/3 known (33%), 2 missing, 1 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 biomarkerLabelMDT ownerDefault trackRequired byNext action
BIO-PDL1-CPSPD-L1 Combined Positive Score (CPS)pathologistyesIND-GASTRIC-METASTATIC-1L-PDL1-CHEMO-ICIVerify result, method, specimen, and report date before sign-off. Expected/constraint: CPS ≥1
BIO-HER2-SOLIDHER2 status (solid tumors — gastric/GEJ/CRC scoring)pathologistnoIND-GASTRIC-METASTATIC-1L-HER2-TOGAVerify result, method, specimen, and report date before sign-off. Expected/constraint: positive (IHC 3+ OR IHC 2+/ISH+)
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).
Specialistskill_idVersionLast reviewedSign-offsDomain
Cellular therapy specialist (CAR-T)cellular_therapy_specialistv0.1.02026-04-250cellular_therapy
Clinical pharmacistclinical_pharmacistv0.1.02026-04-250clinical_pharmacy
Hematologist / oncohematologisthematologistv0.1.02026-04-250hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)hematopathologistv0.1.02026-04-250hematopathology
Infectious disease / hepatologyinfectious_disease_hepatologyv0.1.02026-04-250infectious_diseases
Medical oncologist (solid-tumor chemotherapist)medical_oncologistv0.1.02026-04-250solid_oncology
Molecular geneticist / molecular oncologistmolecular_geneticistv0.1.02026-04-250molecular_oncology
Palliative carepalliative_carev0.1.02026-04-250palliative_care
Pathologist (general)pathologistv0.1.02026-04-250pathology
Primary care / family physicianprimary_carev0.1.02026-04-250primary_care
Psycho-oncologistpsychologistv0.1.02026-04-250psychosocial
Radiation oncologistradiation_oncologistv0.1.02026-04-250radiation_oncology
Radiologistradiologistv0.1.02026-04-250diagnostic_imaging
Social worker / case managersocial_worker_case_managerv0.1.02026-04-250psychosocial
Surgical oncologistsurgical_oncologistv0.1.02026-04-250surgical_oncology
Transplant specialist (BMT)transplant_specialistv0.1.02026-04-250cellular_therapy

Sources cited

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: 2026-05-12.
NCTTitlePhaseStatusSponsorUASignalsEligibility (excerpt)
NCT06128252Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric CancerNARECRUITINGTang-Du HospitalSingle country
NCT06461910Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction AdenocarcinomaPHASE2RECRUITINGZekuan XuSmall N (<50) Single country
NCT05086692A Beta-only IL-2 ImmunoTherapY StudyPHASE1 / PHASE2RECRUITINGMedicenna Therapeutics, Inc.
NCT04895709A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid TumorsPHASE1 / PHASE2RECRUITINGBristol-Myers Squibb
NCT04840264Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel ObstructionPHASE2RECRUITINGSixth Affiliated Hospital, Sun Yat-sen UniversitySingle country
NCT04389632A Study of Sigvotatug Vedotin in Advanced Solid TumorsPHASE1RECRUITINGSeagen, a wholly owned subsidiary of PfizerPhase 1 only
NCT05585580Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior ImmunotherapyPHASE2RECRUITINGQilu Hospital of Shandong UniversitySurrogate endpoint only Single country
NCT05494060XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction AdenocarcinomaPHASE2RECRUITINGThe First Affiliated Hospital with Nanjing Medical UniversitySurrogate endpoint only Single country
NCT06091423XELOX Combined With Fruquintinib and Sintilimab Regimen Conversion Therapy for Gastric Cancer/Gastroesophageal Junction Adenocarcinoma Only With Liver and/or Retroperitoneal Lymph Node Metastasis, a Prospective Single-arm, Multicenter StudyPHASE2RECRUITINGXiaofeng ChenSmall N (<50) Surrogate endpoint only Single country
NCT06841679Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction AdenocarcinomaPHASE2 / PHASE3RECRUITINGBeijing Biostar Pharmaceuticals Co., Ltd.

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).
OptionUA registrationNSZUCost orientationAccess pathway
Standard plan
FOLFOX + Nivolumab (REG-FOLFOX-NIVO)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
Aggressive plan
FLOT (REG-FLOT)
✓ registered✓ covered₴-? — verify pathwayNSZU formulary
Aggressive plan
Trastuzumab + capecitabine + cisplatin (TOGA / KEYNOTE-811) (REG-TRASTUZUMAB-CHEMO-TOGA)
✓ registered✓ covered₴-? — verify pathwayNSZU 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 pathwaynot recorded
Trial · NCT06128252
Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06461910
Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT05086692
A Beta-only IL-2 ImmunoTherapY Study
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT04895709
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT04840264
Docetaxel, Oxaliplatin and 5-FU for Gastric Cancer With Inoperable Malignant Bowel Obstruction
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT04389632
A Study of Sigvotatug Vedotin in Advanced Solid Tumors
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT05585580
Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT05494060
XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06091423
XELOX Combined With Fruquintinib and Sintilimab Regimen Conversion Therapy for Gastric Cancer/Gastroesophageal Junction Adenocarcinoma Only With Liver and/or Retroperitoneal Lymph Node Metastasis, a Prospective Single-arm, Multicenter Study
No UA site listed — international referral required
— unknown— unknown
self-pay: ₴0/course
Trial sponsor
Trial · NCT06841679
Utidelone Capsule Combined With Fluoropyrimidine- and Platinum-containing Therapy in First-line Treatment of Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
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: 2026-05-12.