Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases

August 7, 2024 updated by: Meng Qiu, West China Hospital

Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for R0 Resection of Colorectal Cancer Liver Metastases

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chengdu/Sichuan
      • Chengdu, Chengdu/Sichuan, China, 610000
        • Recruiting
        • Colorectal Cancer Center, West China Hospital
        • Contact:
        • Contact:
          • Phone Number: 8615328007741

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: Tumor antigen-sensitized DC vaccine
subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival
Time Frame: Up to 18 months
Time from assignment to treatment arm until a recurrence or progression of the disease
Up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events Related to Treatment
Time Frame: Up to 12 months
Rate of Adverse Events (AEs) related to the niraparib and dostarlimab combination per CTCAE v5.0
Up to 12 months
Overall Survival (OS)
Time Frame: Up to 36 months
Time from assignment to treatment arm until death due to any cause
Up to 36 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 1 month after the last administration of Tumor Antigen-sensitized DC Vaccine
Adverse events (AE) will be graded and documented according to NCI-CTC AE v4.0 from the beginning of treatment to 1 months after the last date of treatment. Documentary will include severity, lasting period and occurrence time. Main AEs include hypertension, albuminuria, skin reaction of hands and feet, hemorrhage, dysphonia, transaminase rise, abdominal pain / abdominal discomfort, blood bilirubin rise, thyroid dysfunction, infection, diarrhea, fatigue / fatigue, appetite decline, oral mucositis, weight loss, fecal occult blood and platelet count decline
1 month after the last administration of Tumor Antigen-sensitized DC Vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 7, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NeoDC-CRC-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma

Clinical Trials on Tumor antigen-sensitized DC vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe