OncoMatch/Clinical Trials/NCT06148402
Fruquintinib Plus Camrelizumab and Capecitabine as Salvage Therapy After Progression on FOLFOXIRI-based First-line Treatment in Patients With Unresectable/Metastatic Colorectal Cancer
Is NCT06148402 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fruquintinib plus camrelizumab and capecitabine for unresectable/metastatic colorectal cancer.
Treatment: Fruquintinib plus camrelizumab and capecitabine — FOLFOXIRI-based regimen is more used as a first-line therapeutic approach for patients diagnosed with unresectable or metastatic colorectal cancer for its superior efficacy. However, there are no standard recommendations for second-line therapy after progression on FOLFOXIRI with or without targeted therapy. Here, the investigators conduct this open-label, single arm phase II study to evaluate whether fruquintinib in combination with camrelizumab and capecitabine can be the salvage therapy following FOLFOXIRI based regimen for mCRC. Patients diagnosed with unresectable or metastatic colorectal cancer progression on FOLFOXIRI-based regimen are included;or patients have progression or untolerated toxicity with irinotecan, oxaliplatin and fluorouracil successively within one year; patients with BRAF mutation were allowed to receive BRAF inhibitor therapy with or without MEK inhibitor therapy after FOLFOXIRI-based regimen. Patients participated in this study will receive fruquintinib 5 mg once daily, 2 weeks on/1 week off, plus camrelizumab 200 mg Q3W and capecitabine 750mg/square meter twice, 2 weeks on/1 week off, repeated every three weeks. The primary endpoint is Objective Response Rate(ORR). The investigators estimated that 30 patients were necessary. Secondary endpoints include progression-free survival, overall survival, safety, and exploratory ctDNA for efficacy prediction for unresectable or metastatic colorectal cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Allowed: BRAF mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: FOLFOXIRI regimen or sequential administration of irinotecan, oxaliplatin, and fluorouracil (irinotecan, oxaliplatin, fluorouracil) — first-line
Progression or toxicity intolerance of first-line treatment with or without targeted drugs (bevacizumab or cetuximab) with FOLFOXIRI regimen or the sequential administration of irinotecan, oxaliplatin, and fluorouracil within a year
Cannot have received: fruquintinib (fruquintinib)
previous treatment with fruquintinib
Cannot have received: antitumor chemotherapy or biotherapy
Exception: single dose of radiotherapy up to 8Gy for pain relief of non-target lesion during the first 14 days of enrollment
Received antitumor chemotherapy or biotherapy within 28 days prior to the first use of the investigational drug
Lab requirements
Blood counts
Hemoglobin ≥8g/dl, neutrophil absolute count ≥1000/μL, platelets ≥ 75,000 /μL
Kidney function
Serum creatinine ≤1.5 x ULN or calculated creatinine clearance >50mL/min (Cockcroft Gault formula); urinary protein excretion (if protein >30 mg/dL or 2+, 24-hour urinary protein quantity must ≤1g)
Liver function
Total bilirubin ≤1.5 x ULN; alkaline phosphatase, AST (SGOT) and ALT (SGPT) ≤2.5 x ULN (if liver metastasis is present, ≤5 x ULN)
Cardiac function
No history of CHF grade II or higher, active coronary artery disease, MI within 6 months, new/unstable angina, arrhythmias requiring therapy (unless stable/controlled)
Adequate blood, liver and kidney function, as follows: Hemoglobin ≥8g/dl, neutrophil absolute count ≥1000/μL, platelets ≥ 75,000 /μL; Total bilirubin ≤1.5 x ULN, alkaline phosphatase, AST (SGOT) and ALT (SGPT) ≤2.5 x ULN (if liver metastasis is present, ≤5 x ULN), Serum creatinine ≤1.5 x ULN or calculated creatinine clearance >50mL/min (Cockcroft Gault formula), urinary protein excretion (if protein >30 mg/dL or 2+, 24-hour urinary protein quantity must ≤1g); INR or APTT <1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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