OncoMatch/Clinical Trials/NCT07136077
A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
Is NCT07136077 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Tislelizumab and Fruquintinib for minimal residual disease.
Treatment: Tislelizumab · Fruquintinib — To find out if a combination of fruquintinib and tislelizumab can control CRC in patients who have received treatment for the disease but still have "positive" ctDNA tests for MRD (meaning there is evidence of MRD based on this test).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy (oxaliplatin) — adjuvant
must include ≥ 3 months of oxaliplatin containing chemotherapy
Cannot have received: systemic anti-neoplastic therapy
Systemic anti-neoplastic therapies or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy, and immunotherapy
Cannot have received: systemic small molecule-targeted therapy
Systemic small molecule-targeted therapies (eg, tyrosine kinase inhibitors) within 5 halflives or 4 weeks (whichever is shorter) prior to the first dose of study drug
Cannot have received: investigational agent
Is receiving any other investigational agent
Cannot have received: allogeneic stem cell transplantation
Prior allogeneic stem cell transplantation or organ transplantation
Cannot have received: organ transplantation
Prior allogeneic stem cell transplantation or organ transplantation
Lab requirements
Blood counts
Absolute neutrophil count of ≥1.0×10^9/L; Platelet count of ≥100×10^9/L; Hemoglobin ≥9 g/dL
Kidney function
Serum creatinine <1.5× ULN and creatinine clearance (CrCl) ≥30 mL/min per Cockcroft-Gault. Urine protein ≤1+ by dipstick or 24-hour urine protein <1 g/24 hours.
Liver function
Serum total bilirubin ≤1.5× ULN (total bilirubin must be <3× ULN for participants with documented Gilbert's syndrome). ALT and AST ≤2.5× ULN (≤5× ULN with liver metastases)
Cardiac function
Mean QT interval corrected by the method of Fridericia (QTcF) <480 ms
adequate organ and marrow function as defined below: Absolute neutrophil count of ≥1.0×10^9/L; Platelet count of ≥100×10^9/L; Hemoglobin ≥9 g/dL; Serum total bilirubin ≤1.5× ULN (total bilirubin must be <3× ULN for participants with documented Gilbert's syndrome). Participants without liver metastases must have ALT and AST ≤2.5× ULN; participants with liver metastases must have ALT and AST ≤5× ULN. Urine protein ≤1+ by dipstick or 24-hour urine protein <1 g/24 hours. Participants with 2+ proteinuria by dipstick must undergo 24-hour urine collection to assess urine protein level. Serum creatinine <1.5× ULN and creatinine clearance (CrCl) ≥30 mL/min per Cockcroft-Gault. International normalized ratio (INR) and activated prothrombin time (aPTT) ≤1.5 ULN unless the participant is receiving anticoagulation therapy and INR and aPTT values are within the intended therapeutic range. Mean QT interval corrected by the method of Fridericia (QTcF) <480 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- MD Anderson Cancer Center · Houston, Texas
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