OpenOnco · Treatment Plan

Treatment plan — Colorectal carcinoma

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

Patient

VAR-CRC-BIOMARK · Algorithm: ALGO-CRC-ADJUVANT

DiagnosisColorectal carcinoma

MOH / ICD-10C18-C20

ICD-O-38140/3; C18, C19, C20

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-MSI-STATUS	MSI-H	IA	SRC-KEYNOTE-177-ANDRE-2020 SRC-NCCN-COLON-2025 SRC-ESMO-CRC-2024 Evidence cited from clinical guidelines; per-source evidence levels not yet structured. See Phase-2-of-CIViC-pivot for re-cite roadmap.	MSI-H (microsatellite instability-high) CRC is the primary biomarker for first-line pembrolizumab monotherapy (KEYNOTE-177; mPFS 16.5 vs 8.2 mo, HR 0.60; FDA-approved 2020 for 1L mCRC MSI-H). Pembrolizumab is also FDA-approved tumor-agnostically for MSI-H/dMMR solid tumors (KEYNOTE-158, 2017). MSS/pMMR CRC does not benefit from ICI monotherapy. MSI-H (~5% of metastatic CRC) is typically detected by PCR-based fragment analysis or NGS; result correlates closely with IHC-based dMMR testing (MLH1/MSH2/MSH6/PMS2 loss). Threshold selection (MSI-H positive/negative) enforced by algorithm layer; this BMA entry surfaces ESCAT tier context only. For Lynch syndrome germline implications see BMA entries for BIO-MLH1 / BIO-MSH2 / BIO-MSH6 / BIO-PMS2.	pembrolizumab monotherapy (MSI-H 1L mCRC per SRC-KEYNOTE-177-ANDRE-2020, SRC-NCCN-COLON-2025) pembrolizumab monotherapy (tumor-agnostic MSI-H per SRC-ESMO-CRC-2024)	SRC-KEYNOTE-177-ANDRE-2020 SRC-NCCN-COLON-2025 SRC-ESMO-CRC-2024

Primary current-line option

Standard plan

★ DEFAULT

Indication

IND-CRC-ADJUVANT-STAGE3-FOLFOX

Regimen

FOLFOX (mFOLFOX6)

Drugs + NSZU

Oxaliplatin (DRUG-OXALIPLATIN) 85 mg/m² · IV over 2h, day 1 · IV ✓ NSZU covered
Leucovorin (DRUG-LEUCOVORIN) 400 mg/m² · IV over 2h, day 1 (concurrent with oxaliplatin) · IV ✓ NSZU covered
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

Reason

Primary current-line option per algorithm ALGO-CRC-ADJUVANT: selected default was filtered; promoted first remaining current-line track

Other current-line alternatives (1 tracks)

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

Standard plan

Indication

IND-CRC-ADJUVANT-STAGE3-CAPOX

Regimen

CAPOX (XELOX)

Drugs + NSZU

Oxaliplatin (DRUG-OXALIPLATIN) 130 mg/m² · IV over 2h, day 1 · IV ✓ NSZU covered
Capecitabine (DRUG-CAPECITABINE) 1000 mg/m² · PO BID, days 1-14 · PO ✓ NSZU covered

Reason

Current-line alternative presented for HCP consideration

Red flags — PRO / CONTRA aggressive

PRO-AGGRESSIVE

Triggers that push toward the aggressive track

Frailty/age profile precluding doublet-intensive or triplet chemo: ECOG ≥3, OR (age ≥80 + Charlson ≥3), OR composite (age ≥75 + albumin <3.0 + ≥2 comorbidities). Triggers de-escalation toward 5-FU/LV mono, capecitabine mono, or best supportive care. RF-CRC-FRAILTY-AGE

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-CRC-ADJUVANT-STAGE3-FOLFOX)

Do NOT delay adjuvant beyond 8 weeks post-surgery if avoidable — diminishing benefit thereafter
Do NOT continue oxaliplatin past Grade 2 functional neuropathy — switch to 5-FU/LV alone
Do NOT add bevacizumab in adjuvant — NSABP C-08 negative, NOT a standard

Standard plan (IND-CRC-ADJUVANT-STAGE3-CAPOX)

Do NOT use CAPOX if CrCl <30 mL/min — capecitabine renally cleared
Do NOT add bevacizumab — adjuvant bevacizumab NSABP C-08 negative
Do NOT apply IDEA 3-month data from CAPOX to FOLFOX (FOLFOX 3 mo was inferior)
Do NOT delay adjuvant beyond 8 weeks post-surgery
Do NOT continue oxaliplatin past Grade 2 functional neuropathy — switch to capecitabine alone

Timeline

Treatment timeline — derived from regimen + monitoring schedule

Standard plan

Induction · FOLFOX (mFOLFOX6)

14-day cycles × 12 cycles (6 mo) for adjuvant stage III; until progression / unacceptable toxicity for metastatic; 4 cycles (8 wk) periop trials

Standard plan

Induction · CAPOX (XELOX)

21-day cycles × 8 cycles (6 mo) adjuvant stage III; 4 cycles (3 mo) low-risk T1-3 N1 per IDEA

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-ACTIVE-AUTOIMMUNE-DISEASE-ICI-RISK, RF-CRC-BRAF-V600E-POOR-PROGNOSIS, RF-CRC-EMERGENCY-OBSTRUCTION-PERFORATION, RF-CRC-FRAILTY-AGE, RF-CRC-HER2-AMP-ACTIONABLE, RF-CRC-INFECTION-SCREENING, RF-CRC-MSI-H-ACTIONABILITY, RF-CRC-OLIGOMET-LIVER-DEFINITION, RF-CRC-RAS-MUTANT, RF-CRC-RAS-WT, RF-CRC-TRANSFORMATION-PROGRESSION

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	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-COLON-2024: ESMO CRC Clinical Practice Guideline (2024)
SRC-IDEA-GROTHEY-2018: Duration of Adjuvant Chemotherapy for Stage III Colon Cancer (2018)
SRC-MOSAIC-ANDRE-2004: Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer (2004)
SRC-NCCN-COLON-2025: NCCN Colon / Rectal Cancer (v.4.2025)

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
NCT06149481	Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)	PHASE1 / PHASE2	RECRUITING	National Cancer Institute (NCI)	—	Surrogate endpoint only Single country
NCT05378919	Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer	PHASE2	RECRUITING	Lithuanian University of Health Sciences	—	Surrogate endpoint only Single country
NCT05328765	A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection	N/A	RECRUITING	Latin American Cooperative Oncology Group	—	Single country
NCT07213609	A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors	PHASE1 / PHASE2	RECRUITING	GlaxoSmithKline	—	Small N (<50) Surrogate endpoint only
NCT06074536	Impact of Training Patient-centered Approach on Shared Decision in Colorectal Cancer Screening	NA	RECRUITING	CNGE Conseil	—	Single country
NCT04812912	Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer	N/A	RECRUITING	Memorial Sloan Kettering Cancer Center	—	Single country
NCT06663319	A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers	PHASE1	RECRUITING	Janssen Research & Development, LLC	—	Phase 1 only
NCT05848609	Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer	NA	RECRUITING	Universitair Ziekenhuis Brussel	—	Single country
NCT06815406	Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection vs. Endoscopic Submucosal Dissection	NA	RECRUITING	Azienda USL Reggio Emilia - IRCCS	—	Single country
NCT07071714	A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer	PHASE2	RECRUITING	Suzhou Suncadia Biopharmaceuticals 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 FOLFOX (mFOLFOX6) (REG-FOLFOX)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Standard plan CAPOX (XELOX) (REG-CAPOX)	✓ registered	✓ covered	₴-? — verify pathway	NSZU formulary
Trial · NCT06149481 Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC) No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05378919 Neoadjuvant Therapy vs Standard Therapy in Locally Advanced Rectal Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05328765 A Global Record of Patients With Anal Squamous Cell Carcinoma With and Without HIV Infection No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07213609 A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer Agents in Participants With Solid Tumors No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06074536 Impact of Training Patient-centered Approach on Shared Decision in Colorectal Cancer Screening No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT04812912 Changes in Reproductive and Sexual Health in People With Early Onset Colorectal Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06663319 A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT05848609 Functional Status and Quality of Life in Older Patients Undergoing Robotic Surgery for Colorectal Cancer No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT06815406 Recurrence Rate After Endoscopic Resection of , Laterally Spreading Tumor Granular Type (LST-G) of the Colon and Rectum: Endoscopic Mucosal Resection vs. Endoscopic Submucosal Dissection No UA site listed — international referral required	— unknown	— unknown	self-pay: ₴0/course	Trial sponsor
Trial · NCT07071714 A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal 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: 2026-05-12.

plan_id: PLAN-VAR-CRC-BIOMARK-V1 | version: 1 | generated: 2026-05-12T18:41:26.332908+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.