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NOT YET RECRUITING
NCT07854964
NA

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

Sponsor: Tang-Du Hospital

View on ClinicalTrials.gov

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

Official title: A Prospective, Single-center, Phase II Study of Serplulimab Combined With XELOX and Bevacizumab Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2026-10-15

Completion Date

2031-05-15

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

DRUG

Serplulimab

Intravenous infusion, 300 mg, Day 1 of every 3-week cycle, neoadjuvant treatment

DRUG

Bevacizumab

Intravenous infusion, 7.5 mg/kg, Day 1 of every 3-week cycle, neoadjuvant treatment

DRUG

Oxaliplatin

Intravenous infusion, 130 mg/m², Day 1 of every 3-week cycle, XELOX regimen

DRUG

Capecitabine

Oral administration, 1000 mg/m² twice daily, Day 1 to Day 14 of every 3-week cycle, XELOX regimen