Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases

NCT06545630 | Recruiting Phase 1

• 1 other identifier: NeoDC-CRC-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

  Time from assignment to treatment arm until a recurrence or progression of the disease

  Up to 18 months

Secondary Outcomes (3)

• Adverse Events Related to Treatment

  Up to 12 months

• Overall Survival (OS)

  Up to 36 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1 month after the last administration of Tumor Antigen-sensitized DC Vaccine

Study Arms (1)

Participant Group/Arm

EXPERIMENTAL

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

Interventions

Tumor antigen-sensitized DC vaccine BIOLOGICAL

subcutaneous administration

Participant Group/Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Colorectal Cancer Center, West China Hospital

Chengdu, Chengdu/Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: August 9, 2024
• Study Start: November 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: May 1, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)