HAIC Combined With Bevacizumab and Toripalimab for Advanced Hepatocellular Carcinama

NCT04627363 | Unknown Phase 2 DMC

• 1 other identifier: GYEYJR-3
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, single-arm clinical study to preliminarily observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin synchronous combined with Bevacizumab and Toripalimab as the first-line therapy for advanced HCC.

Conditions

Hepatocellular Carcinoma; Bevacizumab; Liver Neoplasms; Toripalimab; Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate at 6 months

  Progression was defined as progressive disease by independent radiologic review according to mRECIST 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 (1)

HAIC plus Bevacizumab and Toripalimab

EXPERIMENTAL

Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 240 mg intravenously every 3 weeks. Bevacizumab 15 mg/kg intravenously every 3 weeks.

Procedure: Hepatic arterial infusion chemotherapy; Drug: Bevacizumab; Drug: Toripalimab

Interventions

Hepatic arterial infusion chemotherapy PROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks

HAIC plus Bevacizumab and Toripalimab

Bevacizumab DRUG

15mg/kg intravenously every 3 weeks

HAIC plus Bevacizumab and Toripalimab

Toripalimab DRUG

240mg intravenously every 3 weeks

HAIC plus Bevacizumab and Toripalimab

Eligibility Criteria

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

You may qualify if:

• HCC diagnosed by histopathological examination or Guidelines for Diagnosis and Treatment of Primary Liver Cancer or the recurrent HCC after surgery;
• age between 18 and 75 years;
• Stage B (middle stage) or C (late stage) HCC determined in accordance with Barcelona Clinic Liver Cancer staging system (BCLC stage). In case of stage B.
• No previous use of any systemic therapy or recurrent HCC.
• Child-Pugh class A or B;
• Eastern Cooperative Group performance status (ECOG) score of 0-2;
• 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
• Prothrombin time ≤18s or international normalized ratio \< 1.7.
• Ability to understand the protocol and to agree to and sign a written informed consent document.

You may not qualify if:

• Cholangiocellular carcinoma (ICC);
• Patients with cancer thrombus in the main trunk of portal vein (Vp4), or cancer thrombus in inferior vena cava should be excluded;
• Accepting ablation or surgery or other system therapy as firt line therapy after diagnose for primary HCC, ablation or system therapy as first line therapy for recurrent HCC.
• Serious medical comorbidities.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Second Affiliated Hospital of Guangzhou Medical University: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Bevacizumab; toripalimab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Fei Gao

  Sun Yat-sen University

  STUDY DIRECTOR

• Kangshun Zhu, Professor

  Second Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Qunfnag Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.com

Fei Gao, Professor

CONTACT

gaof@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 13, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share