Safety and Efficacy of Radiotherapy Plus Sintilimab for HCC With Portal Vein Tumor Thrombosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Study to Evaluate the Safety and Efficacy of Radiotherapy Plus Sintilimab for Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis

Conditions
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Hepatocellular Carcinoma, Portal Vein Tumor Thrombosis

Intervention / Treatment
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* Radiation: Radiotherapy
* Drug: Sintilimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and willingness to sign a written informed consent document. Locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches) Has at least 1 measurable lesion Age ≥18 years Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Adequate organ function Child Pugh class A Life expectancy ≥12 weeks. Antiviral therapy per local standard of care for hepatitis B Woman of child bearing potential must have a negative pregnancy test Must use acceptable form of birth control while on study Exclusion Criteria: Has previously been performed by raditotherapy for the area to be treated. With extrahepatic metastasis History of hepatic encephalopathy or liver transplantation Untreated hepatitis infection: HBV DNA>2000IU/mlor10000 copy/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive Has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes Has had esophageal or gastric variceal bleeding within 3 months prior to study enrollment With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable Evidence of active pulmonary tuberculosis (TB) Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) History of allergic reactions to related drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy Plus Sintilimab<br>HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment. | Radiation: Radiotherapy<br>* 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.<br>Drug: Sintilimab<br>* Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks<br>* Other names: IBI308;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Overall Survival (OS) |  | 2 years |