Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a Phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatment in participants with mCRC-NED. Patients who underwent synchronously or staged removal of primary and metastatic lesions, achieving NED, and histologically confirmed colorectal adenocarcinoma were recruited in this trial. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival (OS) and adverse events. This study will provide novel data on the efficacy and safety profile of the combination of tislelizumab and capecitabine in patients with mCRC-NED.

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

Conditions
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Metastatic Colorectal Cancer，NED

Intervention / Treatment
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* Drug: Tislelizumab + Capecitabine
* Other: Best supportive care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 20 years, < 80 years Written informed consent Histologically or cytologically confirmed CRC Surgery with integrated treatment for metastatic colorectal cancer (mCRC) and achieved a statute of no evidence of disease (NED), as determined by a multidisciplinary tumor board. cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis No previous chemotherapy Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Adequate hematologic and organ function Exclusion Criteria: Presence of any other active cancer Presence of active infections requiring antibiotics History of active autoimmune disease requiring systemic treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tislelizumab + Capecitabine<br>Tislelizumab 200mg every 3 weeks, or 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. | Drug: Tislelizumab + Capecitabine<br>* 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.<br>|
| Active Comparator: Best supportive care<br>Best supportive care was the standard care in this setting. | Other: Best supportive care<br>* Best supportive care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival | The time from NED to the first occurrence of any of the following events: local relapse, distant metastasis, or death from any cause. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The time from NED to death from any cause | 60 months | 
| Adverse events | Side effect of both agents | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Colorectal Cancer，NED