Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tislelizumab + Capecitabine, Best supportive care.
- Who it may be relevant to
- Registry conditions: Metastatic Colorectal Cancer，NED. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
Overview
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.
Interventions
- Drug Tislelizumab + 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. - Other Best supportive care
Best supportive care
Primary outcome measures
- Disease-free survival [Time frame: 36 months]
Secondary outcome measures (2)
- Overall survival [Time frame: 60 months]
- Adverse events [Time frame: 60 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Gastrointestinal Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT05360277 · CSWOG-C02 · GIHSYSU-24