OncoMatch/Clinical Trials/NCT05752136
Preoperative Short-course Radiation Followed by Envafolimab Plus CAPEOX for MSS Locally Advanced Rectal Adenocarcinoma
Is NCT05752136 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Envafolimab for rectal cancer.
Treatment: Envafolimab — Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer.In view of the shortcomings of the current preoperative neoadjuvant treatment model for locally advanced rectal cancer, we will explore the feasibility of a new model of short-course radiotherapy combined with immunotherapy, and develop a possible optimal plan based on the existing theoretical basis, namely "short-course radiotherapy + PD-L1 monoclonal antibody combined with CAPEOX chemotherapy for 2 cycles", and explore the efficacy and adverse effects of this model. The study will also attempt to explore the characteristics of the treatment beneficiary population, explore the characteristics of the treatment beneficiary population by multi-dimensional tumor and microenvironmental information through multi-omics sequencing analysis, attempt to build an efficacy prediction model, early screening of the treatment beneficiary population for precise treatment, and thus explore a new model of radiotherapy combined with immunotherapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient
MMR protein detection or MSI gene detection of rectal cancer specimens confirmed pMMR or MSS before treatment
Required: MSI microsatellite stable
MMR protein detection or MSI gene detection of rectal cancer specimens confirmed pMMR or MSS before treatment
Excluded: MMR deficient
dMMR or MSI-H patients [excluded]
Excluded: MSI microsatellite instability-high
dMMR or MSI-H patients [excluded]
Disease stage
Required: Stage CT2-4A N+, CT3 N0, CT4A N0 (clinical (pelvic contrast-enhanced CT and pelvic high-resolution MRI))
Excluded: Stage T1-2N0, STAGE IV
The clinical staging by pelvic contrast-enhanced CT and pelvic high-resolution MRI were cT2-4a N+, cT3/T4a N0. Patients with clinical staging of T1-2N0 or T4b, or positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI [excluded]. Patients with metastases from other sites (stage IV patients) [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor therapy
Have not received anti-tumor and immunotherapy before enrollment
Cannot have received: immunotherapy
Have not received anti-tumor and immunotherapy before enrollment
Cannot have received: experimental drug
Received any other experimental drug treatment or participated in another interventional clinical trial within 30 days before screening
Lab requirements
Blood counts
White blood cell count >3.5×10^9/L, absolute value of neutrophils >1.8×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥100g/L
Kidney function
24h creatinine clearance >50mL/min or serum creatinine <1.5 times the upper limit of normal
Liver function
Total bilirubin ≤ 1.25 times the upper limit of normal; ALT and AST < 5 times the upper limit of normal
Laboratory inspections must meet the following standards: White blood cell count >3.5×10^9/L, absolute value of neutrophils >1.8×10^9/L, platelet count ≥75×10^9/L, hemoglobin ≥100g/L; INR≤1.5, and APTT≤1.5 times the upper limit of normal or partial prothrombin time (PT) ≤1.5 times the upper limit of normal; Total bilirubin ≤ 1.25 times the upper limit of normal; ALT and AST < 5 times the upper limit of normal; 24h creatinine clearance >50mL/min or serum creatinine <1.5 times the upper limit of normal.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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