Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases

West China Hospital10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma Colorectal Cancer

Interventions

Tumor antigen-sensitized DC vaccineBIOLOGICAL

subcutaneous administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Colorectal Cancer Center, West China Hospital

Chengdu, Chengdu/Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

Disease-free Survival

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

Time frame: Up to 18 months

Secondary Outcomes

Adverse Events Related to Treatment

Rate of Adverse Events (AEs) related to the niraparib and dostarlimab combination per CTCAE v5.0

Time frame: Up to 12 months

Overall Survival (OS)

Time from assignment to treatment arm until death due to any cause

Time frame: Up to 36 months

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

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

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

Data from ClinicalTrials.gov

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