OncoMatch/Clinical Trials/NCT06765616
Adebrelimab Injection (PD-L1) Combined With Short Course Radiotherapy and Chemotherapy for Neoadjuvant Therapy of Locally Advanced Rectal Cancer
Is NCT06765616 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Adebrelimab for rectal cancer.
Treatment: Adebrelimab — This study is a multicenter, single arm, prospective study aimed at evaluating the efficacy and safety of adebelimab combined with short course radiotherapy (5 \* 5Gy) and chemotherapy as preoperative neoadjuvant therapy for locally advanced rectal cancer patients. In the study, all subjects who met the inclusion criteria will receive a combination of adebelimab, short course radiotherapy (5 \* 5Gy), and CAPOX chemotherapy as neoadjuvant therapy according to the study plan. TME surgery will be performed 2-3 weeks after the last dose of neoadjuvant therapy. If the surgery cannot be performed within the time window specified in the protocol (such as delayed adverse reactions, etc.), the researcher will consider the actual clinical situation of the subjects comprehensively.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage CT3 OR HIGHER, CN1+, EMVI (+), MRF (+), SUSPECTED LATERAL LYMPH NODE METASTASIS (>5MM) (cTNM)
Excluded: Stage DISTANT METASTASIS
Patients with cT stage ≥ T3 or cN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (>5mm) who are determined to be operable and require neoadjuvant therapy through imaging and colonoscopy examination.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (such as CTLA-4, OX-40, CD137)
Cannot have received: systemic anti-tumor therapy
The patient has not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc
Cannot have received: systemic traditional Chinese patent medicines or immunomodulatory drugs
Have received systemic treatment of traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks before the first administration
Lab requirements
Blood counts
ANC ≥ 1.5x10^9/L (no G-CSF in past 14 days); Platelets ≥ 100 × 10^9/L (no transfusion in past 14 days); Hemoglobin >9g/dL (no transfusion or erythropoietin in past 14 days)
Kidney function
Blood creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 60 ml/min
Liver function
Total bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN
Cardiac function
Myocardial enzyme spectrum within normal range (clinically insignificant abnormalities allowed); Resting ECG: no significant, difficult to control abnormalities in rhythm, conduction, or morphology; No unstable angina, CHF NYHA ≥ 2, MI within 6 months
Adequate organ function, subjects must meet the following laboratory indicators: ... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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