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NCT05360277 | Recruiting | Metastatic Colorectal Cancer,NED


Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
Sponsor:

Yanhong Deng

Information provided by (Responsible Party):

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.

Condition or disease

Metastatic Colorectal Cancer,NED

Intervention/treatment

Tislelizumab + Capecitabine

Best supportive care

Phase

Phase 2

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 Type : Interventional
Estimated Enrollment : 52 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
Actual Study Start Date : August 22, 2023
Estimated Primary Completion Date : February 28, 2025
Estimated Study Completion Date : November 30, 2027
Arm Intervention/treatment

Experimental: 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.

Drug: Tislelizumab + Capecitabine

Active Comparator: Best supportive care

Best supportive care was the standard care in this setting.

Other: Best supportive care

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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

Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

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Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

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Locations


Recruiting

China, Guangdong

Gastrointestinal Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510655

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