NCT05414461

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for phase_2 colorectal-cancer

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

2.6 years

First QC Date

June 4, 2022

Last Update Submit

June 8, 2022

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Durable clinical benefit

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

    immediately after the intervention

Study Arms (1)

Combination treatment

EXPERIMENTAL

PD-1 inhibitor-based combination treatment

Drug: Combinations

Interventions

CombinationsDRUG

PD-1 inhibitor-based combinaiton treatment

Combination treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who had both baseline measurable lesion(s) and at least one post-baseline radiological disease reassessment
  • patients with identified genomic status

You may not qualify if:

  • patients who received immune monotherapy
  • patients who stopped treatment for any reason without identified response assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

June 4, 2022

First Posted

June 10, 2022

Study Start

March 10, 2019

Primary Completion

October 17, 2021

Study Completion

April 30, 2022

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)