Efficacy of Combination Immunotherapy in Patients With Me... | NCT05414461

Studies
Efficacy of Combination Immunotherapy in Patients With Metastatic Colorectal Cancer

NCT05414461

Sponsor

First Affiliated Hospital of Zhejiang University

Status

Completed

Last Update Posted

Jun 10, 2022Actual

Enrollment

97Actual

Phase

Phase 2

Conditions

Colorectal Cancer

Interventions

Combinations

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2019Actual

Primary Completion Date

Oct 17, 2021Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Jun 4, 2022

First Submission Date that Met QC Criteria

Jun 8, 2022

First Posted Date

Jun 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2022

Last Update Posted Date

Jun 10, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Feng Ye, Chief physician, First Affiliated Hospital of Zhejiang UniversityPrincipal Investigator

Lead Sponsor

First Affiliated Hospital of Zhejiang UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combination treatment	Experimental	PD-1 inhibitor-based combination treatment	Drug: Combinations

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Combinations	Drug	PD-1 inhibitor-based combinaiton treatment	Combination treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Durable clinical benefit	Rate of patients who acheived CR or PR or SD that lasted more than 6 months	immediately after the intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The First Affiliated Hospital, Zhejiang University School of Medicine		Hangzhou	Zhejiang	310003	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided