| Biomarker | Variant | ESCAT | Evidence | Clinical significance | Drugs | Sources |
|---|---|---|---|---|---|---|
| BIO-HRR-PANEL | ATM germline pathogenic | IIA | ATM germline pathogenic confers ~5-10× pancreatic-cancer risk; PARPi activity in ATM-mutated PDAC is modest (POLO germline-only, BRCA-restricted). NCCN recommends platinum-based chemo first; PARPi off-label or trial-only. ESCAT IIA / OncoKB Level 3A. | FOLFIRINOX or gem-cis (platinum induction) olaparib maintenance (off-label, NCCN-listed for HRR-mut) |
| |
| BIO-HRR-PANEL | PALB2 germline pathogenic | IIA |
| PALB2 germline pathogenic in metastatic PDAC: behaves BRCA-like; case series support platinum sensitivity and PARPi activity. POLO germline-only and BRCA- restricted; NCCN allows off-label olaparib for HRR-mutated. ESCAT IIA / OncoKB Level 3A. | FOLFIRINOX (platinum induction) olaparib maintenance (off-label per NCCN) |
|
IND-PDAC-METASTATIC-1L-FOLFIRINOX| ID | Name | Priority | Category | Where to order | Needed for |
|---|---|---|---|---|---|
| TEST-CBC | Complete Blood Count with Differential | Critical | lab | — | all tracks |
| 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) |
| 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 |
| NCT | Title | Phase | Status | Sponsor | UA | Eligibility (excerpt) |
|---|---|---|---|---|---|---|
| NCT07094113 | AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | Amgen | — | |
| NCT07186842 | A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9 | PHASE1 / PHASE2 | RECRUITING | BioNTech SE | — | |
| NCT06835569 | A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations | PHASE1 | RECRUITING | Alterome Therapeutics, Inc. | — | |
| NCT06060405 | Durvalumab and Oleclumab in Resectable PDAC | PHASE2 | RECRUITING | University Health Network, Toronto | — | |
| NCT06158139 | Autologous CAR-T Cells Targeting B7-H3 in PDAC | PHASE1 | RECRUITING | UNC Lineberger Comprehensive Cancer Center | — | |
| NCT06921928 | Study for AZD4360 in Participants With Advanced Solid Tumours | PHASE1 / PHASE2 | RECRUITING | AstraZeneca | — | |
| NCT07261631 | Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors | PHASE1 | RECRUITING | Novartis Pharmaceuticals | — | |
| NCT05518903 | Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma | PHASE2 | RECRUITING | Mayo Clinic | — | |
| NCT07144917 | Immunoparalysis After Pancreaticoduodenectomy | N/A | RECRUITING | Hospices Civils de Lyon | — | |
| NCT04900818 | Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | I-Mab Biopharma US Limited | — |
Verify recruitment status directly with the trial site. ctgov data can lag behind current UA-site status.
| Option | UA registration | NSZU | Cost orientation | Access pathway |
|---|---|---|---|---|
| Standard plan FOLFIRINOX (REG-FOLFIRINOX) | ✓ registered | ✓ covered | ₴-? — verify pathway | NSZU formulary |
| 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 · NCT07094113 AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07186842 A Clinical Trial to Test if the Investigational Drug BNT329 is Safe and Potentially Beneficial for People With Advanced Solid Tumors Known to Express the Tumor Marker CA19-9 No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06835569 A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations 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 · NCT06158139 Autologous CAR-T Cells Targeting B7-H3 in PDAC No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT06921928 Study for AZD4360 in Participants With Advanced Solid Tumours No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07261631 Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT05518903 Investigational Scan (68Ga-FAPI-46 PET/CT) for Imaging of Cancer-Associated Fibroblasts for Localized Pancreatic Ductal Adenocarcinoma No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| Trial · NCT07144917 Immunoparalysis After Pancreaticoduodenectomy No UA site listed — international referral required | — unknown | — unknown | self-pay: ₴0/course | Trial sponsor |
| 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 |
Cost information is orientation. Verify with a specific pharmacy / foundation / trial site. Status updated: 2026-05-04.