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

Sponsor
xiaohua li
Study ID
NCT06808412
Phase
PHASE2
Status
Recruiting
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Conditions

  • Rcctal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Feb 5, 2025
Start date
Jul 5, 2024
Status verified
Jan 2025
Primary completion
May 5, 2025
Completion
Jun 5, 2025

Study Design

Enrollment
118 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with rectal cancer receiving sintilimab combined with bevacizumab and XELOX as a neoadjuvan

Primary Outcome Measure

assess the pathological complete response (pCR) rate of tumors after neoadjuvant chemotherapy for rectal cancer using sintilimab combined with bevacizumab [ Time Frame: 1 year ]

Central Contacts