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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04104074
• Other study ID #: 19048-0-01
• Status: Recruiting
• Phase: Phase 1
• Start date: November 25, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2020
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: Gong Li, MD
• Phone: 0086-10-56119427
• Email: dr_gongli[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.

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:

1. Has previously been performed by raditotherapy for the area to be treated.

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Portal Vein Tumor Thrombosis
• Thrombosis

Intervention

Radiation:
• 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.

Drug:
• Sintilimab
Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks

Locations

Country	Name	City	State
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall response rate (ORR)	Objective response rate based on RECIST v1.1 criteria	1 year
Secondary	Progression-free survival (PFS)		2 years
Secondary	Overall Survival (OS)		2 years