NCT06808412

To Explore the Efficacy of Sintilimab Combined With Bevacizumab in Rectal Cancer

A Study on the Efficacy and Safety of Sintilimab Combined With Bevacizumab in Perioperative Neoadjuvant Chemotherapy for Locally Advanced Low Rectal Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: xiaohua li · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, exploratory clinical study. The primary endpoint of the study is to assess the pathological complete response (pCR) rate of tumors after neoadjuvant chemotherapy for rectal cancer using sintilimab combined with bevacizumab. The aim is to evaluate the efficacy and safety of sintilimab in combination with bevacizumab in the perioperative neoadjuvant chemotherapy for rectal cancer. The study includes two cohorts: Cohort A involves a retrospective collection of rectal cancer patients who previously received the XELOX regimen in the perioperative setting. Cohort B includes rectal cancer patients undergoing perioperative treatment with sintilimab and bevacizumab combined with XELOX as a neoadjuvant regimen. Each of the trial group and historical control group requires 59 cases. The administration method for the trial group (Cohort B) is as follows: Sintilimab: 200 mg, intravenous, Day 1, every 3 weeks. Bevacizumab: 7.5 mg/kg, intravenous, Day 1, every 3 weeks. Chemotherapy regimen: XELOX regimen.

Conditions

• Rcctal Cancer

Interventions

Type	Name	Description
DRUG	sintilimab combined with bevacizumab and XELOX	Patients with locally advanced low rectal cancer receiving sintilimab combined with bevacizumab and XELOX as a neoadjuvant regimen during the perioperative period.

Timeline

• Start date: 2024-07-05
• Primary completion: 2025-05-05
• Completion: 2025-06-05
• First posted: 2025-02-05
• Last updated: 2025-02-05

Locations

1 site across 1 country: China