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NCT05414461 Clinical Trial

Efficacy of Combination Immunotherapy in Patients With Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:
Efficacy of PD-1-inhibitor-based Combination Therapy in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05414461
Other study ID # CombiImmuno mCRC
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 10, 2019
Est. completion date April 30, 2022

Study information
Verified date June 2022
Source First Affiliated Hospital of Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 97
Est. completion date April 30, 2022
Est. primary completion date October 17, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Combinations
PD-1 inhibitor-based combinaiton treatment

Locations
Country Name City State
China The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Durable clinical benefit Rate of patients who acheived CR or PR or SD that lasted more than 6 months immediately after the intervention
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