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

NCT04135690 | Unknown Phase 2 DMC

• 1 other identifier: S0905
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Hepatic arterial infusion chemotherapy; Oxaliplatin, 5-Fluorouracil and Leucovorin; Toripalimab; Sorafenib

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate at 6 months

  Progression was defined as progressive disease by independent radiologic review according to RECIST or death from any cause

  6 months

Secondary Outcomes (4)

• Overall survival (OS)

  6 months

• Progression free survival (PFS)

  6 months

• Objective response rate (ORR)

  6 months

• Adverse events

  6 months

Study Arms (3)

HAIC plus toripalimab

EXPERIMENTAL

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

Procedure: Hepatic arterial infusion chemotherapy; Drug: Toripalimab

HAIC plus sorafenib

ACTIVE COMPARATOR

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

Procedure: Hepatic arterial infusion chemotherapy; Drug: Sorafenib

Patients receiving TKI plus ICI

OTHER

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.

Drug: systemic treatment

Interventions

Hepatic arterial infusion chemotherapy PROCEDURE

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

HAIC plus sorafenib; HAIC plus toripalimab

Toripalimab DRUG

240mg intravenously every 3 weeks

HAIC plus toripalimab

Sorafenib DRUG

400mg bid po

HAIC plus sorafenib

systemic treatment DRUG

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

Patients receiving TKI plus ICI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

toripalimab; Sorafenib; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Combined Modality Therapy; Therapeutics

Central Study Contacts

Ming Shi, MD

CONTACT

+862087343938; shiming@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: October 23, 2019
• Study Start: October 20, 2019
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Locations

CN (1)