RT+ Anti-PD-1 for Patients With Advanced HCC (RT+PD-1-HCC)

January 7, 2020 updated by: Jian-Hong Zhong, Guangxi Medical University

Combining Radiation Therapy With Anti-PD-1 for Patients With Advanced Hepatocellular Carcinoma (RT+PD-1-HCC)

Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Approximately 70-80% of newly diagnosed HCC patients already have advanced disease. Sorafenib and lenvatinib are recommended as first-line options for advanced HCC, the median overall survival of the patients with advanced HCC receiving sorafenib reached 10.7 months. Based on the results of phase II clinical studies and the recommendation of guidelines, the PD-1 monoclonal antibody, such as nivolumab and pembrolizumab, have been approved to treat the patients with advanced HCC by the FDA. PD-1 monoclonal antibody has been recommended as a second-line therapeutic strategy for HCC in the 2018 CSCO guidelines for the diagnosis and treatment of primary liver cancer. However, the results of existing studies indicate that the objective response rate (ORR) of first-line PD-1 antibody therapy for patients with advanced liver cancer is about 20%.

There is a growing recognition of radiation-induced cancer cells-external tumor control mechanisms, in which radiation therapy(RT) contributes not only to local control of target lesions, but also to the control of metastases away from the treatment site. In recent years, RT combined with immunotherapy as a new treatment method has achieved certain curative effect in some patients with metastatic cancer. Therefore, it is interesting to investigate the efficacy of combining radiation therapy plus systemic anti-PD-1 immunotherapy for patients with advanced hepatocellular carcinoma.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-70 years
  • Diagnosis of advanced HCC was confirmed by histopathological examination or clinical diagnosis, consistent with the following two conditions:

    1. Extrahepatic metastasis with more than one measurable lesion;
    2. Intrahepatic multifocal lesions with more than one measurable lesion independent of the radiosurgery field
  • Patients have Child-Pugh A liver function
  • Expected survival ≥ 3 months
  • Unwilling to receive or unable to tolerate first-line treatment with sorafenib

Exclusion Criteria:

  • History of other malignancy
  • History of systemic immunotherapy
  • History of Radiation therapy within 6 months before the first administration
  • History of active autoimmune diseases requiring systemic treatment within 2 years before recruiting.
  • There are active infections that require systemic treatment
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients
  • Diagnosed with immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first administration of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: radiotherapy plus PD-1
The treatment will be started within 1 week after being admitted into the trial. IMRT or SBRT are adopted , and dose of radiation: Dt-PGTV=40Gy/10fractions,Dt-PGTV=30Gy/10fractions,Dt-PGTV=20Gy/10fractions ,and so on.200mg/ of Carelizumab for injection will be given intravenously every 3 weeks for 5 times since the first day of radiotherapy until disease progression, or intolerable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective response rate
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 1 year
1 year
Abscopal effects rate
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 10, 2020

Primary Completion (ANTICIPATED)

June 30, 2020

Study Completion (ANTICIPATED)

July 30, 2020

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 9, 2019

First Posted (ACTUAL)

December 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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