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OpenTrials
Completed

NCT Number: NCT05414461

Efficacy of Combination Immunotherapy in Patients With Metastatic Colorectal Cancer

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combinations

Drug

PD-1 inhibitor-based combinaiton treatment

Primary outcomes

  1. Durable clinical benefit

    Time frame: immediately after the intervention

    Rate of patients who acheived CR or PR or SD that lasted more than 6 months

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jun 10, 2022
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.