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Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer (CAMCO2)

Primary Purpose

Metastatic Colorectal Cancer

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tislelizumab + Capecitabine
Best supportive care
Sponsored by
Yanhong Deng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tislelizumab + Capecitabine

    Best supportive care

    Arm Description

    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 was the standard care in this setting.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Overall survival
    The time from NED to death from any cause
    Adverse events
    Side effect of both agents

    Full Information

    First Posted
    April 30, 2022
    Last Updated
    September 22, 2022
    Sponsor
    Yanhong Deng
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05360277
    Brief Title
    Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer
    Acronym
    CAMCO2
    Official Title
    Maintenance Tislelizumab Combined With Capecitabine to Treat Metastatic Colorectal Cancer With No Evidence of Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    November 30, 2024 (Anticipated)
    Study Completion Date
    November 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Yanhong Deng

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Colorectal Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tislelizumab + Capecitabine
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Best supportive care
    Arm Type
    Active Comparator
    Arm Description
    Best supportive care was the standard care in this setting.
    Intervention Type
    Drug
    Intervention Name(s)
    Tislelizumab + Capecitabine
    Intervention Description
    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
    Other
    Intervention Name(s)
    Best supportive care
    Intervention Description
    Best supportive care
    Primary Outcome Measure Information:
    Title
    Disease-free survival
    Description
    The time from NED to the first occurrence of any of the following events: local relapse, distant metastasis, or death from any cause.
    Time Frame
    36 months
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Description
    The time from NED to death from any cause
    Time Frame
    60 months
    Title
    Adverse events
    Description
    Side effect of both agents
    Time Frame
    60 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Maintenance Tislelizumab + Capecitabine to Treat Metastatic Colorectal Cancer

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