drugset / Trial / NCT07854964

A Prospective, Single-center, Phase II Study of Neoadjuvant Serplulimab Plus XELOX and Bevacizumab in Locally Advanced Rectal Cancer

NCT07854964 ↗

Not yet recruiting 37 enrolled Tang-Du Hospital
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this clinical trial is to understand the treatment effects of serplulimab combined with XELOX and bevacizumab as neoadjuvant therapy for locally advanced rectal cancer. 1. What is the effectiveness of this treatment plan for the treatment of locally advanced rectal cancer ? 2. What is the safety of this treatment for locally advanced rectal cancer ? The type of this study was a single-arm study, and only the patients in the group of Serplulimab combined with XELOX and bevacizumab were observed. Participates will 1. The patient underwent four cycles of neoadjuvant therapy with Serplulimab combined with XELOX and bevacizumab (each cycle lasting three weeks). 2. Preoperative assessment: Imaging evaluation to be conducted within 2-4 weeks after completing neoadjuvant therapy. 3. Timing of surgery: Perform surgery within 4-6 weeks after completing neoadjuvant therapy. 4. Surgical method: Choose the appropriate surgical approach (total mesorectal excision, sphincter-preserving or non-sphincter-preserving) based on the tumour location and extent of descent. 5. Pathological assessment

Timeline

Start
2026-10-15
Primary completion
2030-05-15
Completion
2031-05-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 7.5 mg/kg Intravenous
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Serplulimab Monoclonal antibody 300 mg Intravenous

Indications

No indication recorded.