Safety and Efficacy of Radiotherapy Plus Sintilimab for HCC With Portal Vein Tumor Thrombosis
NCT ID: NCT04104074
Last Updated: 2020-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2019-11-25
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Radiotherapy Plus Sintilimab
HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment.
Radiotherapy
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.
Sintilimab
Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks
Interventions
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Radiotherapy
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.
Sintilimab
Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches)
3. Has at least 1 measurable lesion
4. Age ≥18 years
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
6. Adequate organ function
7. Child Pugh class A
8. Life expectancy ≥12 weeks.
9. Antiviral therapy per local standard of care for hepatitis B
10. Woman of child bearing potential must have a negative pregnancy test
11. Must use acceptable form of birth control while on study
Exclusion Criteria
2. With extrahepatic metastasis
3. History of hepatic encephalopathy or liver transplantation
4. Untreated hepatitis infection: HBV DNA\>2000IU/mlor10000 copy/ml, HCV RNA\> 1000copy/ml, both HbsAg and anti-HCV body are positive
5. Has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes
6. Has had esophageal or gastric variceal bleeding within 3 months prior to study enrollment
7. With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable
8. Evidence of active pulmonary tuberculosis (TB)
9. Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
10. History of allergic reactions to related drugs
18 Years
100 Years
ALL
No
Sponsors
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Beijing Tsinghua Chang Gung Hospital
OTHER
Responsible Party
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Principal Investigators
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Gong Li, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tsinghua Changgeng Hospital
Locations
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Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19048-0-01
Identifier Type: -
Identifier Source: org_study_id
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