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

ConditionRcctal Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

Sponsorxiaohua li

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without using granulocyte colony-stimulating factor in the past 14 days.

Platelet count ≥ 100 x 10^9/L without transfusion in the past 14 days.

Hemoglobin > 9 g/dL without transfusion or use of erythropoietin in the past 14 days;

Total bilirubin ≤ 1.5 × upper limit of normal (ULN); if total bilirubin > 1.5 × ULN but direct bilirubin ≤ ULN, enrollment is also allowed;

Disqualifiers

Significant abnormalities in rhythm, conduction, or morphology on resting ECG that are severe and symptomatic, such as complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmia, or atrial fibrillation;

Unstable angina, congestive heart failure, chronic heart failure classified as NYHA class ≥ 2;

History of any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack;

Poorly controlled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

118 Participants

are divided into 1 treatment group

Group A: Patients with rectal cancer receiving sintilimab combined with bevacizumab and XELOX as a neoadjuvanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

assess the pathological complete response (pCR) rate of tumors after neoadjuvant chemotherapy for rectal cancer using sintilimab combined with bevacizumab

Time frame

1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

xiaohua li

Lead sponsor

Xijing Hospital of Digestive Diseases

Sponsor institution

Source ClinicalTrials.gov

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