OpenOnco · Treatment Plan

Treatment plan — Pancreatic ductal adenocarcinoma

PLAN-VAR-PDAC-BIOMARK-V1 · v1 · 2026-05-12

Patient

VAR-PDAC-BIOMARK · Algorithm: ALGO-PDAC-METASTATIC-1L

DiagnosisPancreatic ductal adenocarcinoma

MOH / ICD-10C25

ICD-O-38500/3; C25

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-BRCA1-BRCA2-GERMLINE	BRCA1 germline pathogenic	IA	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Better Outcome) Resistance or avoidance signal SRC-CIVIC: Level B ⚠ Resistance	BRCA1 germline pathogenic in metastatic PDAC after ≥16 weeks of platinum without progression: olaparib maintenance improves PFS (POLO, Golan 2019). No OS benefit demonstrated but durable PFS responders observed. ESCAT IA / OncoKB Level 1.	olaparib monotherapy maintenance after platinum-based 1L (FOLFIRINOX or gem-cis)	SRC-NCCN-PANCREATIC-2025 SRC-ESMO-PANCREATIC-2024
BIO-BRCA1-BRCA2-GERMLINE	BRCA2 germline pathogenic	IA	Molecular evidence option SRC-CIVIC: Level A (Supports, Sensitivity/Response) SRC-CIVIC: Level B (Supports, Better Outcome) Resistance or avoidance signal SRC-CIVIC: Level B ⚠ Resistance Trial or research option SRC-CIVIC: Level C (Supports, Sensitivity/Response)	BRCA2 germline pathogenic in metastatic PDAC: olaparib maintenance after ≥16 weeks platinum without progression (POLO) → mPFS 7.4 vs 3.8 mo. ESCAT IA / OncoKB Level 1.	olaparib monotherapy maintenance after platinum induction (FOLFIRINOX preferred)	SRC-NCCN-PANCREATIC-2025 SRC-ESMO-PANCREATIC-2024

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-PDAC-METASTATIC-1L-FOLFIRINOX

Regimen

FOLFIRINOX

Drugs + NSZU

Oxaliplatin (DRUG-OXALIPLATIN) 85 mg/m² · IV day 1 every 14d · IV ✓ NSZU covered
Irinotecan (DRUG-IRINOTECAN) 180 mg/m² (full); 150 mg/m² in modified FOLFIRINOX (mFOLFIRINOX) · IV day 1 · IV ⚠ NSZU — not for this indication
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 (modified omits bolus to reduce mucositis) · Day 1 bolus, day 1-2 CIV · IV ✓ NSZU covered

Reason

Primary current-line option selected by ALGO-PDAC-METASTATIC-1L at step 3; branch-driving red flag: RF-PDAC-FIT-FOR-FOLFIRINOX.

Other current-line alternatives (3 tracks)

Same treatment line; review when biomarker, access, contraindication, or patient-context assumptions change.

Standard plan

Indication

IND-PDAC-METASTATIC-1L-NALIRIFOX

Regimen

NALIRIFOX

Drugs + NSZU

Liposomal irinotecan (DRUG-LIPOSOMAL-IRINOTECAN) 50 mg/m² free base (≈60 mg/m² salt equivalent) · IV over 90 min, day 1 every 14d · IV ✗ Not registered in UA
Oxaliplatin (DRUG-OXALIPLATIN) 60 mg/m² · IV day 1 every 14d · IV ✓ NSZU covered
Leucovorin (DRUG-LEUCOVORIN) 400 mg/m² · IV day 1 (after liposomal irinotecan + oxaliplatin) · IV ⚠ NSZU — not for this indication
5-Fluorouracil (DRUG-5-FLUOROURACIL) 2400 mg/m² CIV over 46 h · Day 1 starting after leucovorin, every 14d · IV ✓ NSZU covered

Reason

Current-line alternative presented for HCP consideration

Standard plan

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

Aggressive plan

Indication

IND-PDAC-MAINTENANCE-OLAPARIB-BRCA

Regimen

Olaparib maintenance (BRCA-mut PDAC post-platinum, POLO)

Drugs + NSZU

Olaparib (DRUG-OLAPARIB) 300 mg PO BID continuous · Continuous · PO ⚠ NSZU — not for this indication

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 3 → branch IND-PDAC-METASTATIC-1L-FOLFIRINOX

RF-FITNESS-ECOG-FIT: 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
RF-PDAC-FIT-FOR-FOLFIRINOX ★ winner: Fitness for FOLFIRINOX in metastatic PDAC per PRODIGE-4 / ACCORD-11 inclusion criteria (Conroy NEJM 2011): ECOG 0-1, age ≤75 (≤76 by protocol; convention <=70-75 in real-world), bilirubin ≤1.5× ULN (resolved post-biliary stenting if needed), no significant cardiac comorbidity, adequate hepatic / renal / bone-marrow function. Selects IND-PDAC-METASTATIC-1L-FOLFIRINOX over IND-PDAC-METASTATIC-1L-GEM-NAB-PAC (mOS 11.1 vs 6.8 mo in PRODIGE-4; toxicity tradeoff acceptable in fit patients). Frail / ECOG ≥2 / bilirubin elevated → de-escalate to gem-nab-paclitaxel (MPACT, Von Hoff NEJM 2013). SRC-NCCN-PANCREATIC-2025SRC-ESMO-PANCREATIC-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	—	all tracks
TEST-CMP	Comprehensive Metabolic Panel	Critical	lab	—	standard
TEST-CT-CHEST-ABDOMEN-PELVIS	CT chest + abdomen + pelvis with IV contrast	Critical	imaging	—	standard
TEST-LFT	Liver Function Tests (ALT, AST, bilirubin, ALP, GGT, albumin)	Critical	lab	—	standard
TEST-CT-PET	PET-CT with FDG	Desired	imaging	—	desired (standard)
TEST-NGS-COMPREHENSIVE	Comprehensive NGS tumor panel (DNA + RNA, ≥300 genes)	Desired	histology	CSD Lab: M065	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. RF-PDAC-BILIARY-OBSTRUCTION-CHOLANGITIS
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. RF-PDAC-FRAILTY-AGE
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). RF-PDAC-INFECTION-SCREENING

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-1L-FOLFIRINOX)

Do NOT initiate without resolved jaundice (bilirubin <1.5-2 ULN) — irinotecan hepatotoxic
Do NOT use in PS ≥2 — substantial Grade 3-4 toxicity
Do NOT skip UGT1A1 testing for high-risk populations (preventable severe diarrhea + neutropenia)

Standard plan (IND-PDAC-METASTATIC-1L-NALIRIFOX)

Do NOT initiate without resolved jaundice (bilirubin <1.5-2× ULN) — liposomal irinotecan hepatically metabolized
Do NOT use in PS ≥2 — NAPOLI-3 enrolled only ECOG 0-1; for ECOG 1-2 / older / borderline-fit use gem-nab-pac
Do NOT skip UGT1A1 testing for high-risk populations — *28/*28 homozygotes need starting-dose reduction (40 mg/m² free base) to prevent severe diarrhea + neutropenia
Do NOT skip late-diarrhea loperamide prophylaxis education — Grade 3-4 ~20% (higher than gem-nab-pac); patient must have loperamide at home and know the schedule
Do NOT start without vascular access (PICC or port) for 46-h continuous-infusion 5-FU
Do NOT confuse liposomal irinotecan with conventional irinotecan — different pharmacokinetics, dosing, and approved indications; ONIVYDE and Camptosar are not interchangeable

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

Aggressive plan (IND-PDAC-MAINTENANCE-OLAPARIB-BRCA)

Do NOT start without confirmed CR/PR/SD to platinum-induction
Do NOT skip pre-treatment counseling on long-term MDS/AML risk
Do NOT use in tumor-only-BRCA without germline confirmation (POLO inclusion was germline)

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · FOLFIRINOX

14-day cycles × 12 cycles (PRODIGE-24 adjuvant); until progression / toxicity (metastatic)

Standard plan

Induction · NALIRIFOX

14-day cycles × Until disease progression or unacceptable toxicity

Standard plan

Induction · Gemcitabine + nab-paclitaxel (MPACT)

28-day cycles × Until progression / unacceptable toxicity

MDT brief

Discussion questions (1, 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

MDT talk tree (3 steps)

#	Owner	Topic	Action
1	hematologist	Staging / disease burden	What is the current LDH? Marker of tumor burden and transformation.
2	clinical_pharmacist	Specialist review	Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
3	molecular_geneticist	Specialist review	Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.

Skills (recommended) — for consideration (2)

Clinical pharmacist recommended
Chemoimmunotherapy regimen — drug-drug interactions, dose adjustments, premedication.
Molecular geneticist / molecular oncologist recommended
Indication references an actionable genomic biomarker — mutation / target / actionability interpretation needed.

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: 1/1 known (100%), 0 missing, 0 default-track gaps
Unevaluated RedFlags: 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

Technical MDT skill metadata (2/16 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	Domain
Cellular therapy specialist (CAR-T)	`cellular_therapy_specialist`	v0.1.0	2026-04-25	cellular_therapy
Clinical pharmacist	`clinical_pharmacist`	v0.1.0	2026-04-25	clinical_pharmacy
Hematologist / oncohematologist	`hematologist`	v0.1.0	2026-04-25	hematology_oncology
Hematopathologist (lymphoma / leukemia / myeloma)	`hematopathologist`	v0.1.0	2026-04-25	hematopathology
Infectious disease / hepatology	`infectious_disease_hepatology`	v0.1.0	2026-04-25	infectious_diseases
Medical oncologist (solid-tumor chemotherapist)	`medical_oncologist`	v0.1.0	2026-04-25	solid_oncology
Molecular geneticist / molecular oncologist	`molecular_geneticist`	v0.1.0	2026-04-25	molecular_oncology
Palliative care	`palliative_care`	v0.1.0	2026-04-25	palliative_care
Pathologist (general)	`pathologist`	v0.1.0	2026-04-25	pathology
Primary care / family physician	`primary_care`	v0.1.0	2026-04-25	primary_care
Psycho-oncologist	`psychologist`	v0.1.0	2026-04-25	psychosocial
Radiation oncologist	`radiation_oncologist`	v0.1.0	2026-04-25	radiation_oncology
Radiologist	`radiologist`	v0.1.0	2026-04-25	diagnostic_imaging
Social worker / case manager	`social_worker_case_manager`	v0.1.0	2026-04-25	psychosocial
Surgical oncologist	`surgical_oncologist`	v0.1.0	2026-04-25	surgical_oncology
Transplant specialist (BMT)	`transplant_specialist`	v0.1.0	2026-04-25	cellular_therapy

Sources cited

SRC-ESMO-PANCREATIC-2024: ESMO Pancreatic Cancer (2024)
SRC-NAPOLI-3-WAINBERG-2024: NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial (2023)
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: 2026-05-12.

NCT	Title	Phase	Status	Sponsor	UA	Signals
NCT06756074	Reinforced Pancreaticojejunostomy With or Without glubran2	PHASE2	RECRUITING	Minia University	—	Single country
NCT06405490	NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC	PHASE2	RECRUITING	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	—	Small N (<50) Surrogate endpoint only Single country
NCT05851924	A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC)	PHASE2	RECRUITING	Memorial Sloan Kettering Cancer Center	—	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	Casa di Cura Dott. Pederzoli	—	Single country
NCT07224750	A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer	N/A	RECRUITING	City of Hope Medical Center	—	Single country
NCT07522073	A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma	PHASE3	RECRUITING	Incyte Corporation	—	—
NCT06060405	Durvalumab and Oleclumab in Resectable PDAC	PHASE2	RECRUITING	University Health Network, Toronto	—	Small N (<50) Single country
NCT04575363	RPSA as a Potential Prognostic Biomarker of Pancreatic Cancer	NA	RECRUITING	CHU de Reims	—	Single country
NCT02600949	Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer	PHASE1	RECRUITING	M.D. Anderson Cancer Center	—	Phase 1 only Single country
NCT06261359	A Study of CEND-1 With Chemotherapy as First-Line Therapy in Patients With Pancreatic Ductal Adenocarcinoma	PHASE2	RECRUITING	Qilu Pharmaceutical Co., Ltd.	—	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 FOLFIRINOX (REG-FOLFIRINOX)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan NALIRIFOX (REG-NALIRIFOX) 1/4 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
Aggressive plan Olaparib maintenance (BRCA-mut PDAC post-platinum, POLO) (REG-OLAPARIB-MAINT-PDAC)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT06756074 Reinforced Pancreaticojejunostomy With or Without glubran2 No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06405490 NALIRI-XELOX+AK104 for First-line Treatment of Advanced PDAC No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05851924 A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC) 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 · NCT07224750 A Noninvasive and Screening miRNA Signature for Gastrointestinal Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07522073 A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06060405 Durvalumab and Oleclumab in Resectable PDAC No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04575363 RPSA as a Potential Prognostic Biomarker of Pancreatic Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT02600949 Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer 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: 2026-05-12.

plan_id: PLAN-VAR-PDAC-BIOMARK-V1 | version: 1 | generated: 2026-05-12T18:41:26.613245+00:00

Per FDA non-device CDS positioning (CHARTER §15): Outpatient oncology treatment planning to support tumor-board discussion. Not a medical device; not for autonomous clinical decision-making.

Per FDA non-device CDS positioning (CHARTER §15): Both treatment options below are presented for review. The engine's selection of a 'recommended' default does not constitute a clinical decision. Final treatment selection requires HCP judgment incorporating information not available to the system.

This document is an informational resource supporting tumor-board discussion (per CHARTER §11). It is not a system that makes clinical decisions. Every recommendation must be verified by the treating physician.