RecruitingPhase 2NCT05585814

CapeOX Combined With Bevacizumab Plus Anti-PD1 Antibody as Neoadjuvant Therapy for Microsatellite Stable Locally Advanced Rectal Cancer

CapeOX Combined With Bevacizumab Plus Pembrolizumab as Neoadjuvant Therapy for Microsatellite Stable Locally Advanced Rectal Cancer (COBP)


Sponsor

Shanghai Changzheng Hospital

Enrollment

30 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective, single-arm study aims to investigate the efficacy and safety of pembrolizumab plus bevacizumab and chemotherapy as neoadjuvant treatment in pMMR/MSS locally advanced rectal cancer patients


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding immunotherapy (an anti-PD-1 antibody) to standard chemotherapy and a targeted anti-blood-vessel drug (bevacizumab) before surgery improves outcomes for people with locally advanced rectal cancer that does not have a specific genetic feature (microsatellite stable, or MSS) that usually predicts a response to immunotherapy. **You may be eligible if...** - You have confirmed rectal cancer that has grown through the bowel wall and spread to nearby lymph nodes, but not to distant organs - Your cancer is MSS/pMMR (a specific genetic status confirmed by testing) - You are in good physical health - You have not received prior chemotherapy, targeted therapy, or recent radiation for this cancer **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body - Your cancer is MSI-high (a different genetic status) - You have poor organ function (liver, kidney, blood counts) - You have recently received chemotherapy or radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 3 cycles

DRUGOxaliplatin

Oxaliplatin is given by intravenous infusion at 130mg / m2 on Day 1 every 3 weeks for 3cycles

DRUGBevacizumab

Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 3 cycles

DRUGPembrolizumab

Pembrolizumab is given intravenously at 200 mg on day 1 every 3 weeks for 3 cycles


Locations(1)

Shanghai Changzheng Hospital

Shanghai, China

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NCT05585814


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