OncoMatch/Clinical Trials/NCT05229003
Irinotecan Plus Anlotinib or Further in Combination With Penpulimab for Second-line Treatment of mCRC
Is NCT05229003 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Anlotinib and Penpulimab for metastatic colorectal cancer.
Treatment: Anlotinib · Penpulimab · Irinotecan — This is an exploratory, non-controlled, multi-cohort, phase II small-sample clinical study designed to evaluate the clinical benefit of second-line treatment with anlotinib plus irinotecan or further in combination with a PD-1 monoclonal antibody (penpulimab) in patients with advanced colorectal cancer after first-line treatment failure. To explore the rationality of the combination of chemotherapy and targeted therapy and immunotherapy strategy and obtain relevant survival and safety data. The study will fully evaluate the efficacy, PFS, OS, safety and related biomarkers of the regimen.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: KRAS any tested
the type of KRAS, NRAS, BRAF, and MSI were known
Required: NRAS any tested
the type of KRAS, NRAS, BRAF, and MSI were known
Required: BRAF wild-type
requiring wild type of BRAF
Required: MSH2 proficient mismatch repair
Cohort A required patients with MSS/pMMR status
Required: MSH6 proficient mismatch repair
Cohort A required patients with MSS/pMMR status
Required: MLH1 proficient mismatch repair
Cohort A required patients with MSS/pMMR status
Required: PMS2 proficient mismatch repair
Cohort A required patients with MSS/pMMR status
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (oxaliplatin) — first-line
The patient received oxaliplatin in combination with fluorouracil as the first-line systemic therapy (with or without anti-EGFR mab or VEGF mab) and failed. Fluorouracil (5-FU, capecitabine, or S-1) and oxaliplatin must be included in the first-line regimens.
Must have received: antimetabolite (fluorouracil, capecitabine, S-1) — first-line
Fluorouracil (5-FU, capecitabine, or S-1) and oxaliplatin must be included in the first-line regimens.
Cannot have received: topoisomerase inhibitor (irinotecan)
Former treatment of irinotecan for 1 or more cycles
Cannot have received: anti-VEGFR small molecule inhibitor (apatinib, regorafenib, fruquintinib, anlotinib)
Prior exposure to any anti-VEGFR small molecule inhibitors (e.g. Apatinib, regorafenib, Fruquintinib, Anlotinib, etc.)
Cannot have received: anti-PD-1 therapy
Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell costimulation or immune checkpoint pathways
Lab requirements
Blood counts
ANC ≥1.5x10^9/L; Hemoglobin ≥8.0g/dL; Platelet count ≥80x10^9/L
Kidney function
Serum creatinine ≤1 x ULN, the clearance rate of endogenous creatinine >50ml/min
Liver function
Total bilirubin < 1.5x ULN; ALT and AST < 2.5x ULN (with liver metastasis <5x ULN)
Cardiac function
No coronary heart disease of grade I or above, arrhythmia of grade I or above (including prolonged QTc interval >450ms in males and >470ms in females), and cardiac dysfunction of grade I or above
Bone marrow capacity and liver and kidney function were sufficiently reserved within 7 days before screening: absolute neutrophil (ANC) count ≥1.5x109 /L; Hemoglobin ≥ 8.0g/ dL; Platelet count ≥80 x109 /L; Total bilirubin < 1.5 times upper normal limit (ULN); ALT and AST< 2.5x ULN (with liver metastasis <5x ULN); Serum creatinine ≤1 x ULN, the clearance rate of endogenous creatinine >50ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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