Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases

NCT ID: NCT06545630

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-05-31

Brief Summary

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The aim of this study is to explore the safety and efficacy of tumor antigen-sensitized DC vaccine in postoperative adjuvant treatment of R0 excision Colorectal Cancer Liver Metastases.

Detailed Description

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Conditions

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Carcinoma Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participant Group/Arm

Tumor antigen-sensitized vaccine is administrated, 1-week interval, totally 2 times.

2-week later, Neo-antigen DC vaccine is administrated, 2-week interval, totally 5 times.

According to the conditions of patients, it will be used for five more times

Group Type EXPERIMENTAL

Tumor antigen-sensitized DC vaccine

Intervention Type BIOLOGICAL

subcutaneous administration

Interventions

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Tumor antigen-sensitized DC vaccine

subcutaneous administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Pathologically confirmed diagnosis of colorectal cancer; Karnofsky performance status 0-1; Patients with tumors identified by pathologic immunohistochemistry as pMMR or by genetic testing as MSS/MSI-L; Imaging diagnosis of stage IV, resection of both primary and metastatic tumors and had NED status after surgery; With a high risk of recurrence, such as liver metastasis CRS score \>3 or successful conversion therapy; Multiple peritoneal metastases after CC0; Function of the main organs is normal; Edition Patient's written informed consent

Exclusion Criteria

Tumor emergencies; Abnormal coagulation function; Contagious diseases, such as HIV, HBV, HCV infection; Mental disorders; Concomitant tumors; Immunological co-morbidities
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Meng Qiu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Colorectal Cancer Center, West China Hospital

Chengdu, Chengdu/Sichuan, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Yu-Wen Zhou

Role: primary

8615328007741

Role: backup

8615328007741

Other Identifiers

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NeoDC-CRC-01

Identifier Type: -

Identifier Source: org_study_id

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