RecruitingPhase 2NCT05360277

Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease


Sponsor

Yanhong Deng

Enrollment

52 participants

Start Date

Aug 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Surgery with integrated treatment for metastatic colorectal cancer (mCRC) has created a new clinical setting known as mCRC with no evidence of disease (NED). However, these patients have a high risk of developing persistent cancer. This study aimed to investigate the efficacy and safety of Tislelizumab combined with capecitabine as a maintenance treatment for patients with mCRC-NED.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the immunotherapy drug tislelizumab plus the oral chemotherapy drug capecitabine as maintenance treatment can prevent colorectal cancer from coming back after surgery and chemotherapy achieved no visible remaining disease. **You may be eligible if...** - You are between 20 and 79 years old - You have colorectal cancer that spread (metastatic) and underwent surgery, achieving no evidence of disease - Your surgery removed all visible tumors (CC0 resection if peritoneal spread was present) - You have not received any prior chemotherapy - You had no more than 3 sites of metastatic spread **You may NOT be eligible if...** - You had prior chemotherapy for colorectal cancer - You have active autoimmune disease - You have uncontrolled serious medical conditions - You are pregnant or breastfeeding 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

DRUGTislelizumab + Capecitabine

Tislelizumab 200mg iv every 3 weeks, for 1 year after completion of perioperative chemotherapy. Capecitabine was given at a dose of 850 mg/m2 twice a day by mouth, 2 weeks on/ 1 week off, for 1 year after completion of perioperative chemotherapy.

OTHERBest supportive care

Best supportive care


Locations(1)

Gastrointestinal Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT05360277