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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant Group/Arm | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor antigen-sensitized DC vaccine | Biological | subcutaneous administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | Time from assignment to treatment arm until a recurrence or progression of the disease | Up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Related to Treatment | Rate of Adverse Events (AEs) related to the niraparib and dostarlimab combination per CTCAE v5.0 | Up to 12 months |
| Overall Survival (OS) | Time from assignment to treatment arm until death due to any cause |
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Inclusion Criteria:
Pathologically confirmed diagnosis of colorectal cancerï¼› 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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorectal Cancer Center, West China Hospital | Recruiting | Chengdu | Chengdu/Sichuan | 610000 | China |
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| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007414 | Intestinal Neoplasms |
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| 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 | 1 month after the last administration of Tumor Antigen-sensitized DC Vaccine |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |