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OncoMatch/Clinical Trials/NCT06485713

Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib for Third-line Treatment of mCRC

Is NCT06485713 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including trifluridine/tipiracil combined with fufuquitinib and fufuquitinib for metastatic colorectal cancer.

Phase 2RecruitingFirst Affiliated Hospital of Wenzhou Medical UniversityNCT06485713Data as of May 2026

Treatment: trifluridine/tipiracil combined with fufuquitinib · fufuquitinib · Trifluridine/tipiracilTo evaluate the efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib in patients with unresectable metastatic colorectal cancer.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Metastatic disease required

advanced colorectal adenocarcinoma; At least 1 measurable lesion was present according to RECIST1.1 criteria

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: standard first- and second-line treatment

who had failed standard first - and second-line treatment

Lab requirements

Blood counts

Hemoglobin ≥90g/L; Absolute count of neutrophils (ANC) ≥1.5×10^9/L; Platelet ≥100×10^9/L

Kidney function

Serum creatinine (CR) <1.5 ULN or creatinine clearance (CCR) ≥50ml/min

Liver function

ALT and AST ≤2.5 ULN; ALP ≤2.5 ULN (if liver metastases ≤5 ULN); Total bilirubin (TBIL) < 1.5 ULN

Cardiac function

Left ventricular ejection fraction (LVEF) ≥50%

Good organ function, laboratory tests meet the following criteria: Hemoglobin ≥90g/L; ANC ≥1.5×10^9/L; Platelet ≥100×10^9/L; ALT and AST ≤2.5 ULN; ALP ≤2.5 ULN (if liver metastases ≤5 ULN); Total bilirubin (TBIL) < 1.5 ULN; Serum creatinine (CR) <1.5 ULN or creatinine clearance (CCR) ≥50ml/min; Serum albumin ≥30g/L; INR, PT, APTT ≤1.5 ULN; TSH ≤ULN; LVEF ≥50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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