Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

Phase 2

Recruiting

• Conditions: Metastatic Colorectal Cancer，NED
• Interventions: Drug: Tislelizumab + Capecitabine; Other: Best supportive care

• Registration Number: NCT05360277
• Lead Sponsor: Yanhong Deng

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-04-30
• Study First Submitted QC: 2022-04-30
• Study First Posted: 2022-05-04
• Study Start: 2023-08-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-12
• Primary Completion: 2025-02-28
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Age ≥ 20 years, < 80 years
2. Written informed consent
3. Histologically or cytologically confirmed CRC
4. 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.
5. cytoreduction surgery achieves CC0 (no visible residual tumor) if there is peritoneal metastasis
6. No previous chemotherapy
7. Synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved
8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
9. Adequate hematologic and organ function

Exclusion Criteria

1. Presence of any other active cancer
2. Presence of active infections requiring antibiotics
3. History of active autoimmune disease requiring systemic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tislelizumab + Capecitabine	Tislelizumab + Capecitabine	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.
Best supportive care	Best supportive care	Best supportive care was the standard care in this setting.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adverse events	60 months	Side effect of both agents
Overall survival	60 months	The time from NED to death from any cause

Trial Locations

Locations (1)

Gastrointestinal Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China