OncoMatch/Clinical Trials/NCT06647680
Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）
Is NCT06647680 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles for rectal cancer patients.
Treatment: Receive the experimental combination of drugs (chemoradiation (Oxaliplatin and Capecitabine) + PD-1 inhibitor (Tislelizumab) for 3 cycles — To evaluate the safety and preliminary efficacy of preoperative chemotherapy and PD-1 inhibitor Tislelizumab for Rectal Cancer patients.Go through laboratory and medical tests to verify eligibility to enter the study, receive the experimental combination of drugs CAPOX (Oxaliplatin and Capecitabine) for 3 cycles prior to surgery and undergo laboratory tests and study procedures on specified days during the study period, complete end of study evaluations and tests, and participate in post-study follow up every three months for three years.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Lab requirements
Blood counts
ANC ≥ 1,200 cells/mm3; platelets ≥ 100,000 cells/mm3; hemoglobin ≥ 8.0 g/dl
Kidney function
serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 30 mL/min
Liver function
total bilirubin must be ≤ ULN (unless Gilbert's disease or similar syndrome, then ≤ 1.5 x ULN); AST and ALT must be ≤3 x ULN; if AST/ALT ≥ ULN but ≤ 3 x ULN, Hepatitis B and C serology must be negative
Adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3 Platelets ≥ 100,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl. Adequate hepatic function: total bilirubin must be ≤ ULN (unless Gilbert's disease or similar syndrome, then ≤ 1.5 x ULN); AST and ALT must be ≤3 x ULN; if AST/ALT ≥ ULN but ≤ 3 x ULN, Hepatitis B and C serology must be negative. Adequate renal function: serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify