Carcinoma, Colorectal Cancer
Conditions
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.
Interventions
BIOLOGICALTumor antigen-sensitized DC vaccine
subcutaneous administration
Sponsors
West China Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free Survival | Up to 18 months | Time from assignment to treatment arm until a recurrence or progression of the disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Overall Survival (OS) | Up to 36 months | Time from assignment to treatment arm until death due to any cause |
| 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 |
Countries
China
Outcome results
None listed