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

Primary Purpose

Hepatocellular Carcinoma, Portal Vein Tumor Thrombosis

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Radiotherapy

Sintilimab

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beijing Tsinghua Changgung HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy Plus Sintilimab

Arm Description

HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment.

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events

Safety and tolerability of radiotherapy plus sintilimab based on NCI CTCAE v4.03 and RTOG/EORTC criteria

Secondary Outcome Measures

Overall response rate (ORR)

Objective response rate based on RECIST v1.1 criteria

Progression-free survival (PFS)

Overall Survival (OS)

Full Information

NCT ID

NCT04104074

First Posted

September 24, 2019

Last Updated

July 5, 2020

Sponsor

Beijing Tsinghua Chang Gung Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04104074

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

November 25, 2019 (Actual)

Primary Completion Date

July 31, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Tsinghua Chang Gung Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma, Portal Vein Tumor Thrombosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy Plus Sintilimab

Arm Type

Experimental

Arm Description

HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment.

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Other Intervention Name(s)

IBI308

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of treatment-emergent adverse events

Description

Safety and tolerability of radiotherapy plus sintilimab based on NCI CTCAE v4.03 and RTOG/EORTC criteria

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall response rate (ORR)

Description

Objective response rate based on RECIST v1.1 criteria

Time Frame

1 year

Title

Progression-free survival (PFS)

Time Frame

2 years

Title

Overall Survival (OS)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gong Li, MD

Phone

0086-10-56119427

dr_gongli@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gong Li, MD

Organizational Affiliation

Beijing Tsinghua Changgeng Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Tsinghua Changgung Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

102218

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gong Li, MD

dr_gongli@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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