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

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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma; Portal Vein Tumor Thrombosis
• Intervention / Treatment: Radiation: Radiotherapy; Drug: Sintilimab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Gong Li, MD; Phone Number: 0086-10-56119427; Email: dr_gongli@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 102218
      • Recruiting
      • Beijing Tsinghua Changgung Hospital
      • Contact: Gong Li, MD; Email: dr_gongli@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiotherapy Plus Sintilimab; HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment.	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; Other Names: IBI308

What is the study measuring?

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 Survival (OS)		2 years
Progression-free survival (PFS)		2 years
Overall response rate (ORR)	Objective response rate based on RECIST v1.1 criteria	1 year

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Principal Investigator: Gong Li, MD, Beijing Tsinghua Changgeng Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2019
• Primary Completion (Anticipated): July 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 5, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Embolism and Thrombosis; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Thrombosis
• Other Study ID Numbers: 19048-0-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No