OncoMatch/Clinical Trials/NCT06647680
Neoadjuvant Chemotherapy and PD-1 Inhibitor for Locally Advanced Rectal Cancer（CONTROL-01）
Is NCT06647680 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Cancer type
Colorectal Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06647680 currently recruiting?
Yes, this trial is currently recruiting patients.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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 qualifyRelated pages