Patient
VERIFIED-PDAC-L2-PDAC_METASTATIC_2L_NAL_IRI · Algorithm: ALGO-PDAC-METASTATIC-2L
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 |
|---|
| No clinically actionable variants matched in this profile. |
Primary current-line option
- Indication
- IND-PDAC-METASTATIC-2L-NAL-IRI
- Regimen
- Nal-IRI + 5-FU/LV (PDAC, 2L nanoliposomal irinotecan)
- Drugs + NSZU
- Nanoliposomal irinotecan (DRUG-NAL-IRI) 70 mg/m² free base (= 80 mg/m² irinotecan HCl salt) IV over 90 min, day 1 · Day 1 q14 days · IV ✗ Not registered in UA
- Leucovorin (DRUG-LEUCOVORIN) 400 mg/m² IV over 30 min (begin after nal-IRI infusion), day 1 · Day 1 q14 days · IV ⚠ NSZU — not for this indication
- 5-Fluorouracil (DRUG-5-FLUOROURACIL) 2400 mg/m² IV 46-hour continuous infusion (begin after LV), days 1-3 · 46h CI starting day 1, q14 days · IV_CI ✓ NSZU covered
- Reason
- Provisional current-line default from ALGO-PDAC-METASTATIC-2L: step 2 did not select a treatment branch. Biliary obstruction with bilirubin >2× ULN: address obstruction first (endoscopic biliary stent or percutaneous drain). Irinotecan and most cytotoxics are contraindicated with significant hyperbilirubinemia. Reassess for 2L once bilirubin <2× ULN.
Other current-line alternatives (1 tracks)
Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.
- Indication
- IND-PDAC-METASTATIC-1L-GEM-NAB-PAC
- Regimen
- Gemcitabine + nab-paclitaxel (MPACT)
- Drugs + NSZU
- Gemcitabine (DRUG-GEMCITABINE) 1000 mg/m² · IV days 1, 8, 15 of 28-d cycle · IV ✓ NSZU covered
- Nab-paclitaxel (albumin-bound paclitaxel) (DRUG-NAB-PACLITAXEL) 125 mg/m² · IV days 1, 8, 15 of 28-d cycle · IV ✓ NSZU covered
- 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 2
- RF-FITNESS-ECOG-FIT ★ winner: Fit performance status (ECOG 0-1): patient is fully active or restricted in physically strenuous activity but ambulatory and able to carry out light work. Eligible for full-dose chemotherapy and intensive regimens (CHOEP, BEACOPP-escalated, HD-MTX, ASCT consolidation, CAR-T).
SRC-NCCN-BCELL-2025SRC-ESMO-DLBCL-2024
Pre-treatment investigations
Investigations before treatment start · critical / standard / desired · merged across tracks
| ID | Name | Priority | Category | Where to order | Needed for |
|---|
| TEST-BILIRUBIN-TOTAL | Total bilirubin | Critical | lab | — | all tracks |
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | all tracks |
| TEST-CECT-CAP | CECT chest/abdomen/pelvis | Critical | imaging | — | all tracks |
| TEST-CMP | Comprehensive Metabolic Panel | Critical | lab | — | all tracks |
| TEST-LFT | Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin) | Critical | lab | — | all tracks |
| TEST-CA19-9 | CA 19-9 | Standard | lab | — | all tracks |
| TEST-UGT1A1-GENOTYPE | UGT1A1 genotype | Standard | genomic | — | desired (standard) |
Red flags — PRO / CONTRA aggressive
PRO-AGGRESSIVE
Triggers that push toward the aggressive track
- Obstructive jaundice / cholangitis in PDAC: total bilirubin ≥3 mg/dL with pancreatic-head mass causing biliary tree dilation, OR active cholangitis (fever + RUQ pain + jaundice). Mandates biliary drainage (ERCP-stent or PTC) BEFORE chemo, which is hepatotoxic and reduces clearance of cytotoxics.
~70% of head-of-pancreas tumors present with jaundice. Biliary stent (preferred metallic for life expectancy >3 mo, plastic for shorter) via ERCP first-line; PTC if ERCP fails. Resolve bilirubin to <2 mg/dL before initiating gem-nab-pac…
RF-PDAC-BILIARY-OBSTRUCTION-CHOLANGITISSRC-NCCN-PANCREATIC-2025SRC-ESMO-PANCREATIC-2024 - Frailty profile precluding FOLFIRINOX in PDAC: ECOG ≥2, OR (age ≥75 + Charlson ≥3), OR composite (age ≥70 + albumin <3.0 + cachexia ≥10% weight loss). Triggers gem-nab-pac (better-tolerated alternative) OR gemcitabine monotherapy OR best supportive care.
ACCORD-11 excluded ECOG ≥2; FOLFIRINOX in real-world frail patients has Grade 3-4 toxicity ~75% + early discontinuation. MPACT trial for gem-nab-pac was more permissive (KPS 70-100); better fit for the borderline-fit patient. Pure BSC for…
RF-PDAC-FRAILTY-AGESRC-NCCN-PANCREATIC-2025SRC-ESMO-PANCREATIC-2024 - Infection-screening gate before PDAC FOLFIRINOX / gem-nab-pac: HBsAg+ / anti-HBc+ (HBV reactivation on dexamethasone-containing regimens), HIV+, OR active cholangitis (post-stent infectious complication — common given biliary instrumentation in head-of-pancreas tumors).
Cholangitis typically post-stenting (~10-20% of plastic stents, lower for metallic). Treat with antibiotics + drainage adjustment; delay chemo until afebrile + bilirubin trending down.
RF-PDAC-INFECTION-SCREENINGSRC-NCCN-PANCREATIC-2025SRC-ESMO-PANCREATIC-2024 - Organ dysfunction that may make standard PDAC systemic therapy unsafe.
Draft structural RedFlag stub added to resolve existing indication references.
RF-PDAC-ORGAN-DYSFUNCTION
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-PDAC-METASTATIC-2L-NAL-IRI)
- Не призначати при загальному білірубіno >2× ULN — спочатку дренувати жовчну обструкцію; іринотекан є гепатично метаболізованим
- Не використовувати nal-IRI монотерапію (без 5-FU/LV) — NAPOLI-1 монотерапевтична рука НЕ показала ЗВ-переваги (HR 0.99)
- Не призначати після FOLFIRINOX-базованої 1L — призначити гемцитабін ± наб-пакліyesсел як 2L (перехресна резистентnoсть по іринотекан/5-FU можлива)
- Не пропускати профілактику пізньої діареї лоперамідом — Grade 3-4 у ~13%; пацієнт повинен мати лоперамід вдома та знати схему
- Не починати при відсутності судинного доступу (PICC або порт) для 46-годинної CI 5-FU
Standard plan (IND-PDAC-METASTATIC-1L-GEM-NAB-PAC)
- Do NOT use without addressing biliary obstruction first
- Do NOT continue past Grade 2 functional neuropathy without dose reduction
Timeline
Treatment timeline — derived from regimen + monitoring schedule
Standard plan
Induction · Nal-IRI + 5-FU/LV (PDAC, 2L nanoliposomal irinotecan)
14-day cycles × Continue until progression or unacceptable toxicity
Standard plan
Induction · Gemcitabine + nab-paclitaxel (MPACT)
28-day cycles × Until progression / unacceptable toxicity
MDT brief
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: 0/0 known (100%), 0 missing, 0 default-track gaps
- Unevaluated RedFlags: RF-ATM-CONFIRMED-CARRIER, RF-ATM-FAMILY-HISTORY-SUSPICION, RF-BRCA-CONFIRMED-CARRIER, RF-BRCA-HBOC-FAMILY-HISTORY-SUSPICION, RF-CASCADE-BRCA-FDR-POSITIVE, RF-CASCADE-FAP-FDR-POSITIVE, RF-CASCADE-LYNCH-FDR-POSITIVE, RF-CDKN2A-SPECIFIC-PDAC-CARRIER, RF-CHRONIC-PANCREATITIS-PDAC-PREVENTION, RF-CHRONIC-T2DM-CANCER-RISK-PREVENTION, RF-FAMILIAL-PANCREATIC-CANCER-SYNDROME, RF-FAMMM-CONFIRMED-CARRIER, RF-FAMMM-FAMILY-HISTORY-SUSPICION, RF-FAP-CONFIRMED-CARRIER, RF-FAP-FAMILY-HISTORY-SUSPICION, RF-JPS-CONFIRMED-CARRIER, RF-LIFESTYLE-SMOKELESS-TOBACCO-PREVENTION, RF-LIFESTYLE-SUGARY-BEVERAGES-PREVENTION, RF-LIFESTYLE-TOBACCO-CANCER-PREVENTION, RF-LYNCH-CONFIRMED-CARRIER, RF-LYNCH-FAMILY-HISTORY-SUSPICION, RF-PALB2-CONFIRMED-CARRIER, RF-PALB2-FAMILY-HISTORY-SUSPICION, RF-PAN-ATM-CHEK2-CDK12-PARPI-CANDIDATE, RF-PAN-BRCA-SOMATIC-PARPI-CANDIDATE, RF-PAN-PALB2-PARPI-CANDIDATE, RF-PDAC-BILIARY-OBSTRUCTION-CHOLANGITIS, RF-PDAC-FRAILTY-AGE, RF-PDAC-HIGH-RISK-BIOLOGY, RF-PDAC-INFECTION-SCREENING, RF-PDAC-TRANSFORMATION-PROGRESSION, RF-PEUTZ-JEGHERS-CONFIRMED-CARRIER, RF-PEUTZ-JEGHERS-FAMILY-HISTORY-SUSPICION, RF-VHL-FAMILY-HISTORY-SUSPICION
Technical MDT skill metadata (0/16 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-ESMO-PANCREATIC-2024: ESMO Pancreatic Cancer (2024)
- SRC-NAPOLI1-WANG-GILLAM-2016: Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial ()
- SRC-NCCN-PANCREATIC-2025: NCCN Pancreatic Adenocarcinoma (v.2.2025)
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: 2026-07-15.
| NCT | Title | Phase | Status | Sponsor | UA | Signals | Eligibility (excerpt) |
|---|
| NCT04900818 | Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | — | Phase 1 only | |
| NCT04291651 | UCSF PANC Cyst Registry | N/A | RECRUITING | — | Single country | |
| NCT07542041 | Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens | NA | RECRUITING | — | Single country | |
| NCT07217717 | Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC) | PHASE3 | RECRUITING | — | Single country | |
| NCT05346536 | Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) CTCs (CTC-AXL-PANC) | NA | RECRUITING | — | Single country | |
| NCT07114861 | The KN510713 Study in Combination With mFOLFIRINOX | PHASE1 / PHASE2 | RECRUITING | — | Small N (<50) Single country | |
| NCT07532590 | Patients With Pancreatic Tumor: Use of an App to Monitor Progress in a Simple and Intuitive Way by Periodically Completing Targeted Questionnaires and Providing Educational and Informational Content (PancreasPlus). | NA | RECRUITING | — | Single country | |
| NCT07024615 | A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer | PHASE1 | RECRUITING | — | Phase 1 only Small N (<50) Single country | |
| NCT05688215 | Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma | PHASE1 / PHASE2 | RECRUITING | — | Surrogate endpoint only Single country | |
| NCT06261359 | A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma | PHASE2 | RECRUITING | — | Surrogate endpoint only 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 |
|---|
| Standard plan Nal-IRI + 5-FU/LV (PDAC, 2L nanoliposomal irinotecan) (REG-NAL-IRI-5FU-LV-PDAC) 1/3 component drug(s) not registered in Ukraine +1 | ✗ not registered | ✗ out-of-pocket | ₴-? — verify pathway | not recorded |
| Standard plan Gemcitabine + nab-paclitaxel (MPACT) (REG-GEM-NAB-PAC) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| Trial · NCT04900818 Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT04291651 UCSF PANC Cyst Registry No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07542041 Artidis Nanomechanical Signature Profiling of Pancreatic Cancer Specimens No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07217717 Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05346536 Liquid Biopsy and Pancreas Cancer: Detection of AXL(+) CTCs (CTC-AXL-PANC) No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07114861 The KN510713 Study in Combination With mFOLFIRINOX No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07532590 Patients With Pancreatic Tumor: Use of an App to Monitor Progress in a Simple and Intuitive Way by Periodically Completing Targeted Questionnaires and Providing Educational and Informational Content (PancreasPlus). No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07024615 A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05688215 Zimberelimab and Quemliclustat in Combination With Chemotherapy for the Treatment of Patients With Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06261359 A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal 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: 2026-07-15.