OncoMatch/Clinical Trials/NCT07347951
A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer
Is NCT07347951 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including CAPOX chemotherapy and Targeted therapy with bevacizumab for locally advanced rectal cancer (larc).
Treatment: CAPOX chemotherapy · Targeted therapy with bevacizumab · Serplulimab immunotherapy — In a single-center, prospective, phase II study (ClinicalTrials registration number: \[to be filled in\]) initiated by our center to evaluate the safety and preliminary efficacy of short-course radiotherapy followed by sequential CAPOX chemotherapy combined with serplulimab and bevacizumab as total neoadjuvant therapy for MSS-type mid-low locally advanced rectal cancer, patients with mid-low MSS-type locally advanced rectal adenocarcinoma were enrolled. They received short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy. It is anticipated that 30 subjects with locally advanced rectal cancer will be enrolled between September 2025 and September 2027. This phase II exploratory study targets patients with locally advanced mid-low MSS/pMMR rectal cancer. It employs short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy, aiming to clarify the efficacy and safety of this new combined radiotherapy, chemotherapy, targeted therapy, and immunotherapy approach, while also assessing the rectal/anal preservation rate and quality of life of patients. After neoadjuvant therapy, patients will undergo imaging and endoscopic evaluations to determine subsequent treatment strategies. Radical surgical resection will be performed on patients after neoadjuvant immunotherapy, followed by further analysis of the pathological complete response (pCR) rate. The primary study endpoint is the pCR rate, and secondary study endpoints include the objective response rate, organ preservation rate, 3-year disease-free survival (DFS), 3-year overall survival (OS), incidence of adverse events, and quality of life scores (EORTC QLQ-C30, EORTC QLQ-CR29, Wexner).
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MSH2 positive protein expression (positive)
immunohistochemistry of tumor biopsy indicates pMMR (positive for MSH1, MSH2, MSH6, and PMS2 proteins)
Required: MSH6 positive protein expression (positive)
immunohistochemistry of tumor biopsy indicates pMMR (positive for MSH1, MSH2, MSH6, and PMS2 proteins)
Required: PMS2 positive protein expression (positive)
immunohistochemistry of tumor biopsy indicates pMMR (positive for MSH1, MSH2, MSH6, and PMS2 proteins)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: antitumor therapy
No prior antitumor therapy
Cannot have received: immunotherapy
No prior...immunotherapy
Cannot have received: anti-angiogenic therapy
No prior...anti-angiogenic therapy
Cannot have received: pelvic radiotherapy
No prior...pelvic radiotherapy
Lab requirements
Blood counts
WBC ≥3.5×10⁹/L, ANC ≥1.8×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥100 g/L; INR ≤1.5, APTT ≤1.5x ULN, or PTT ≤1.5x ULN
Kidney function
24-hour creatinine clearance rate ≥50 mL/min or serum creatinine ≤1.5x ULN
Liver function
Total bilirubin ≤1.25x ULN; ALT and AST ≤3x ULN; serum albumin ≥28 g/L
Laboratory tests must meet the following criteria: i. White blood cell count ≥3.5×10⁹/L, absolute neutrophil count ≥1.8×10⁹/L, platelet count ≥100×10⁹/L, and hemoglobin ≥100 g/L; ii. INR ≤1.5, and APTT ≤1.5 times the upper limit of normal, or partial thromboplastin time (PTT) ≤1.5 times the upper limit of normal; iii. Total bilirubin ≤1.25 times the upper limit of normal; ALT and AST ≤3 times the upper limit of normal; serum albumin ≥28 g/L; iv. 24-hour creatinine clearance rate ≥50 mL/min or serum creatinine ≤1.5 times the upper limit of normal.
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