Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases

Sichuan University

Status and phase: Enrolling; Phase 1

Conditions: Carcinoma; Colorectal Cancer

Treatments: Biological: Tumor antigen-sensitized DC vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT06545630

NeoDC-CRC-01

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Participant Group/Arm

Experimental group

Description:

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

Treatment:

Biological: Tumor antigen-sensitized DC vaccine