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Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

NCT ID: NCT05360277

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-22

Study Completion Date

2027-11-30

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.

Conditions

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Metastatic Colorectal Cancer，NED

Keywords

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Metastatic Colorectal Cancer，NED

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Tislelizumab + Capecitabine

Intervention Type DRUG

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.

Best supportive care

Best supportive care was the standard care in this setting.

Group Type ACTIVE_COMPARATOR

Best supportive care

Intervention Type OTHER

Best supportive care

Interventions

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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.

Intervention Type DRUG

Best supportive care

Best supportive care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yanhong Deng

OTHER

Sponsor Role lead

Responsible Party

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Yanhong Deng

Professer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Gastrointestinal Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yanhong Deng, MD

Role: primary

Other Identifiers

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GIHSYSU-24

Identifier Type: OTHER

Identifier Source: secondary_id

CSWOG-C02

Identifier Type: -

Identifier Source: org_study_id