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

NCT06808412 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2025-02-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • xiaohua li

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-05
Primary Completion
2025-05-05
Completion
2025-06-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06808412 on ClinicalTrials.gov