Toripalimab Plus Stereotactic Body Radiotherapy for HCC With PVTT

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Toripalimab; Radiation: Stereotactic body radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04169399

HCC-S1001

Details and patient eligibility

About

To explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus.

Full description

Programmed Cell Death Protein-1 (PD-1) was effective and tolerable in patients with advanced hepatocellular carcinoma. Additionally, previous studies showed that stereotactic body radiotherapy (SBRT) was effective for hepatocellular carcinoma with portal vein tumor thrombus (PVTT). No study has evaluated the efficacy and safety of toripalimab plus SBRT for hepatocellular carcinoma with PVTT. Thus, the investigators carried out this prospective study to find out it.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
• Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria
• The normal liver volume in the non-target area was greater than 700ml
• Portal vein tumor thrumbus confirmed in two image techniques
• Eastern Cooperative Oncology Group performance status of 0 to 2
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• With no previous radiotherapy and immunotherapy
• Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy.
• The following laboratory parameters:

Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3 Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion criteria

• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known central nervous system tumors including metastatic brain disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Toripalimab plus SBRT

Experimental group

Description:

Participants received 240mg toripalimab intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. Participants recevied Stereotactic body radiotherapy. Radiotherapy dose was 36 \~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks.

Treatment:

Drug: Toripalimab

Radiation: Stereotactic body radiotherapy