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
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
Treatments tested in this trial
- sintilimab combined with bevacizumab and XELOX
Treatment groups
118 Participants
are divided into 1 treatment groupSponsors and collaborators
xiaohua li
Lead sponsor
Xijing Hospital of Digestive Diseases
Sponsor institution
Source ClinicalTrials.gov