OncoMatch/Clinical Trials/NCT05954429
A Study to Explore the Third-line Treatment of Fruquintinib Combined With Serplulimab in Advanced Non-liver-limited Metastatic Colorectal Cancer: a Single-center, Phase 2 Study
Is NCT05954429 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including serplulimab and Fruquintinib for colorectal cancer.
Treatment: serplulimab · Fruquintinib — The aim of this clinical trial is to learn about efficacy of fruquintinib combined with serplulimab in patients with microsatellite stabilized mCRC who have failed standard therapy. The main purpose is to explore efficacy, safety and tolerability of the treatment. At the same time, the correlation between biomarkers (including ctDNA, TPS, CPS, tumor mutation burden, lymphocyte subpopulation, cytokines, TCR, intestinal microbes, etc.) and the efficacy and drug resistance mechanism will be analyzed, which could provide reference for determining the advantaged group.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MLH1 proficient mismatch repair (pMMR) by immunohistochemistry
tumor tissue was pMMR by immunohistochemistry
Required: MSH2 proficient mismatch repair (pMMR) by immunohistochemistry
tumor tissue was pMMR by immunohistochemistry
Required: MSH6 proficient mismatch repair (pMMR) by immunohistochemistry
tumor tissue was pMMR by immunohistochemistry
Required: PMS2 proficient mismatch repair (pMMR) by immunohistochemistry
tumor tissue was pMMR by immunohistochemistry
Required: MLH1 microsatellite stable (MSS) by PCR or NGS
MSS by PCR or NGS
Required: MLH1 microsatellite instability-low (MSI-L) by PCR or NGS
MSI-L by PCR or NGS
Excluded: MLH1 deficient mismatch repair (dMMR) by immunohistochemistry
Tumor tissues were dMMR detected by immunohistochemistry
Excluded: MLH1 microsatellite instability-high (MSI-H) by PCR or NGS
MSI-H detected by PCR or NGS
Allowed: KRAS wild-type
For RAS wild-type patients, combined with anti-EGFR monoclonal antibody
Allowed: NRAS wild-type
For RAS wild-type patients, combined with anti-EGFR monoclonal antibody
Allowed: BRAF mutation
For patients with BRAF mutations, BRAF inhibitor therapy is recommended when drugs are available
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: fluorouracil
Fluorouracil
Must have received: oxaliplatin
oxaliplatin
Must have received: irinotecan
irinotecan
Must have received: anti-VEGF monoclonal antibody
With or without anti-VEGF monoclonal antibody
Must have received: anti-EGFR monoclonal antibody
For RAS wild-type patients, combined with anti-EGFR monoclonal antibody
Must have received: BRAF inhibitor
For patients with BRAF mutations, BRAF inhibitor therapy is recommended when drugs are available
Cannot have received: anti-PD-1 therapy
Prior treatment with PD-1 antibody
Cannot have received: anti-PD-L1 therapy
Prior treatment with PD-L1 antibody
Cannot have received: anti-CTLA-4 therapy
Prior treatment with CTLA-4 antibody
Lab requirements
Blood counts
neutrophil ≥1.5×10^9/L; Platelet ≥100×10^9/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl
Kidney function
Serum creatinine ≤ 1.5x ULN, creatinine clearance ≥60ml/min
Liver function
bilirubin ≤ 1.5x ULN; ALT and AST ≤ 2x ULN
Good organ function: neutrophil ≥1.5×10^9/L; Platelet ≥100×10^9/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl; TSH ≤ 1x ULN, T3 and T4 in the normal range; bilirubin ≤ 1.5x ULN; ALT and AST ≤ 2x ULN; Serum creatinine ≤ 1.5x ULN, creatinine clearance ≥60ml/min; INR or PT ≤ 1.5x ULN, unless the patient is receiving anticoagulant therapy and the PT value is within the intended range for anticoagulant therapy; aPTT ≤ 1.5x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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