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The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.
The patients were divided into two groups. The first group: the single dose of radiotherapy was 200 cGy, once a day, the total dose was 5000 cGy. The second group: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy Plus Sintilimab | Experimental | HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy | Radiation | Arm 1: The single radiotherapy dose was 200cGy, once a day, and the total dose was 5000cGy. Arm 2: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Safety and tolerability of radiotherapy plus sintilimab based on NCI CTCAE v4.03 and RTOG/EORTC criteria | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Objective response rate based on RECIST v1.1 criteria | 1 year |
| Progression-free survival (PFS) | 2 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gong Li, MD | Contact | 0086-10-56119427 | dr_gongli@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Gong Li, MD | Beijing Tsinghua Changgeng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | Beijing Municipality | 102218 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| C000632826 | sintilimab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Sintilimab | Drug | Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks |
|
|
| Overall Survival (OS) |
| 2 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |