Back to resultsEfficacy of Combination Immunotherapy in Patients With Metastatic Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Combinations
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- patients who had both baseline measurable lesion(s) and at least one post-baseline radiological disease reassessment
- patients with identified genomic status
Exclusion Criteria:
- patients who received immune monotherapy
- patients who stopped treatment for any reason without identified response assessment.
Sites / Locations
- The First Affiliated Hospital, Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Combination treatment
Arm Description
PD-1 inhibitor-based combination treatment
Outcomes
Primary Outcome Measures
Durable clinical benefit
Rate of patients who acheived CR or PR or SD that lasted more than 6 months
Secondary Outcome Measures
Full Information
NCT ID
NCT05414461
First Posted
June 4, 2022
Last Updated
June 8, 2022
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05414461
Brief Title
Efficacy of Combination Immunotherapy in Patients With Metastatic Colorectal Cancer
Official Title
Efficacy of PD-1-inhibitor-based Combination Therapy in Patients With Metastatic Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2019 (Actual)
Primary Completion Date
October 17, 2021 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
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
Immunotherapy improved efficacy and survival in selective patients with metastatic colorectal cancer (mCRC), however, limited data revealed the landscape of immunotherapy efficacy. What's more, potential markers have not been comprehensively evaluated to identify responding patients to further improve efficacy.The investigators conducted a single-arm study to investigate the efficacy of combination immunotherapy in patients with mCRC, and the combined regimen is determined by the physician in charge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination treatment
Arm Type
Experimental
Arm Description
PD-1 inhibitor-based combination treatment
Intervention Type
Drug
Intervention Name(s)
Combinations
Intervention Description
PD-1 inhibitor-based combinaiton treatment
Primary Outcome Measure Information:
Title
Durable clinical benefit
Description
Rate of patients who acheived CR or PR or SD that lasted more than 6 months
Time Frame
immediately after the intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients who had both baseline measurable lesion(s) and at least one post-baseline radiological disease reassessment
patients with identified genomic status
Exclusion Criteria:
patients who received immune monotherapy
patients who stopped treatment for any reason without identified response assessment.
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Combination Immunotherapy in Patients With Metastatic Colorectal Cancer
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