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Trial Title:
Tumor Antigen-sensitized DC Vaccine for Colorectal Cancer Liver Metastases
NCT ID:
NCT06545630
Condition:
Carcinoma
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Tumor antigen-sensitized DC vaccine
Description:
subcutaneous administration
Arm group label:
Participant Group/Arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Colorectal Cancer Center, West China Hospital
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu-Wen Zhou
Phone:
8615328007741
Email:
drzhouyuwen@163.com
Contact backup:
Phone:
8615328007741
Start date:
November 1, 2023
Completion date:
May 2026
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06545630
