HAIC Plus Toripalimab vs. HAIC Plus Sorafenib for HCC With PVTT: a Non-comparative, Prospective, Randomized Trial

NCT ID: NCT04135690

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-20
• Study Completion Date: 2023-12-20

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus toripalimab versus hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib in patients with hepatocellular carcinoma (HCC) with portal vein tumor thrombus.

Detailed Description

Our previous study showed that hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib was more effective and safe than sorafenib for hepatocellular carcinoma with portal vein tumor thrombus. Programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared HAIC plus toripalimab with HAIC plus sorafenib. Thus, the investigators carried out this prospective, randomized, non-comparative study to find out it.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HAIC plus toripalimab

Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Toripalimab 240mg intravenously every 3 weeks.

Group Type: EXPERIMENTAL

Hepatic arterial infusion chemotherapy

Intervention Type: PROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks

Toripalimab

Intervention Type: DRUG

240mg intravenously every 3 weeks

HAIC plus sorafenib

Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Sorafenib 400mg twice daily (Bid) oral dosing.

Group Type: ACTIVE_COMPARATOR

Hepatic arterial infusion chemotherapy

Intervention Type: PROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks

Sorafenib

Intervention Type: DRUG

400mg bid po

Patients receiving TKI plus ICI

Patients, who meet the inclusion criteria but withdraw consent or reject this study, receive systemic treatment according to the doctor. Systemic treatment include atezolizumab+bevacizumab, camrelizumab+apatinib, sintilimab+bevacizumab and so on.

Group Type: OTHER

systemic treatment

Intervention Type: DRUG

atezolizumab+bevacizumab, camrelizumab+apatinib, sintilimab+bevacizumab and so on

Interventions

Hepatic arterial infusion chemotherapy

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks

Intervention Type: PROCEDURE

Toripalimab

240mg intravenously every 3 weeks

Intervention Type: DRUG

Sorafenib

400mg bid po

Intervention Type: DRUG

systemic treatment

atezolizumab+bevacizumab, camrelizumab+apatinib, sintilimab+bevacizumab and so on

Intervention Type: DRUG

Eligibility Criteria

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 EASL criteria.
• Patients with portal vein tumor thrombus
• Eastern Cooperative Oncology Group performance status of 0 to 2
• With no previous treatment
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
• The following laboratory parameters:

Platelet ≥75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Shi Ming

Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Shi, MD

Role: CONTACT

shiming@sysucc.org.cn

+862087343938

Facility Contacts

Ming Shi, MD

Role: primary

shiming@mail.sysu.edu.cn

8620-87343115

Other Identifiers

S0905

Identifier Type: -

Identifier Source: org_study_id