A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With On… (NCT07543848) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Prospective, Multicenter, Single-Arm Phase II Exploratory Study of Serplulimab Combined With Oncolytic Virus H101, Short-Course Radiotherapy, and XELOX Chemotherapy as Total Neoadjuvant Treatment for Locally Advanced (cT1-3N0M0) Rectal Cancer
China20 participantsStarted 2026-05-01
Plain-language summary
This study aims to evaluate the safety and effectiveness of a combination treatment including a PD-1 inhibitor (serplulimab), oncolytic virus H101, short-course radiotherapy, and XELOX chemotherapy as total neoadjuvant therapy in patients with locally advanced low rectal cancer (cT1-3N0M0).
In this prospective, multicenter, single-arm phase II study, eligible patients will receive a standardized treatment regimen consisting of intratumoral injection of oncolytic virus H101, short-course radiotherapy, chemotherapy, and immunotherapy over multiple cycles. Tumor response will be assessed using imaging, endoscopy, and clinical evaluation after completion of treatment.
The primary objective is to determine the 1-year clinical complete response rate. Secondary outcomes include tumor response rate, organ preservation rate, survival outcomes, and treatment safety.
The results of this study may help improve treatment strategies for rectal cancer, increase the rate of complete response, and provide more opportunities for organ preservation while maintaining safety.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 18 to 80 years, male or female.
✓. Histologically confirmed low rectal adenocarcinoma, with tumor located ≤5 cm from the anal verge.
✓. Clinical stage T1-3N0M0 according to AJCC staging criteria.
✓. Mismatch repair-proficient (pMMR) or microsatellite stable (MSS) tumor confirmed by immunohistochemistry or genetic testing.
✓. No prior anti-tumor treatment.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, with an expected survival of at least 3 months.
✓. Adequate organ function, including:
✓. Thyroid function within normal range or adequately controlled.
Exclusion criteria
✕. Histology other than rectal adenocarcinoma (e.g., gastrointestinal stromal tumor, lymphoma).