OncoMatch/Clinical Trials/NCT07284992
SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC
Is NCT07284992 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including short-term radiotherapy combined with Adebrelimab and capox and long-term radiotherapy combined with Adebrelimab and capox for rectal cancer.
Treatment: short-term radiotherapy combined with Adebrelimab and capox · long-term radiotherapy combined with Adebrelimab and capox — This is a multicenter, cohort, prospective study to evaluate the efficacy and safety of Adebrelimab combined with radiotherapy and chemotherapy as preoperative neoadjuvant therapy for patients with locally advanced rectal cancer. In the study, all subjects who meet the inclusion criteria will enter the short-term radiotherapy queue and the long-term radiotherapy queue at the ratio of 1:1. The short-term radiotherapy queue plans to receive Adebrelimab combined with short-term radiotherapy (5\*5Gy) and Capox chemotherapy as neoadjuvant therapy. The long-term radiotherapy queue plans to receive Adebrelimab combined with long-term radiotherapy (1.8gy × 25-28 times) and capox chemotherapy as neoadjuvant therapy. The TME surgery will be performed 2-3 weeks after the last neoadjuvant therapy is completed. If the surgery cannot be performed within the time window specified in the plan (such as delayed adverse reactions, etc.), the researcher will conduct the surgery according to the patients' requirements.The actual clinical conditions of the subjects were comprehensively considered.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage T3 OR HIGHER, N1+ (CT stage, CN stage)
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 judged by imaging and colonoscopy to be operable and need neoadjuvant therapy
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
have 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 (e.g., 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 Chinese patent medicine with anti-tumor indications or immunomodulatory effect
have received systemic treatment with Chinese patent medicine 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 without G-CSF in past 14 days; Platelets ≥ 100 × 10^9/l without blood transfusion in recent 14 days; Hemoglobin >9g/dl without blood transfusion or erythropoietin in recent 14 days
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 60 ml/min
Liver function
Total bilirubin ≤ 1.5 × ULN; AST and ALT ≤ 2.5 × ULN
Cardiac function
Myocardial enzyme spectrum is within the normal range; resting ECG significant abnormalities excluded; unstable angina, CHF NYHA ≥ 2, MI within 6 months excluded
sufficient organ function, the subject shall meet the following laboratory indicators: ... see full text
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