Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases
Tumor Antigen-sensitized DC Vaccine as an Adjuvant Therapy for R0 Resection of Colorectal Cancer Liver Metastases
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Chengdu/Sichuan
-
Chengdu, Chengdu/Sichuan, China, 610000
- Recruiting
- Colorectal Cancer Center, West China Hospital
-
Contact:
- Yu-Wen Zhou
- Phone Number: 8615328007741
- Email: drzhouyuwen@163.com
-
Contact:
- Phone Number: 8615328007741
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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