Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases

Phase 1

Recruiting

• Conditions: Carcinoma; Colorectal Cancer
• Interventions: Biological: Tumor antigen-sensitized DC vaccine

• Registration Number: NCT06545630
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-11
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participant Group/Arm	Tumor antigen-sensitized DC vaccine	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

Primary Outcome Measures

Name	Time	Method
Disease-free Survival	Up to 18 months	Time from assignment to treatment arm until a recurrence or progression of the disease

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 36 months	Time from assignment to treatment arm until death due to any cause
Adverse Events Related to Treatment	Up to 12 months	Rate of Adverse Events (AEs) related to the niraparib and dostarlimab combination per CTCAE v5.0
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	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

Trial Locations

Locations (1)

Colorectal Cancer Center, West China Hospital; 🇨🇳 Chengdu, Chengdu/Sichuan, China