HAIC Plus A+T for Patients With High-risk HCC: a Single-arm Phase 2 Trial

NCT05886465 | Unknown Phase 2 DMC

• 1 other identifier: S-014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Atezolizumab plus bevacizumab is the first-line treatment for patients with advanced hepatocellular carcinoma. However, the prognosis for high-risk hepatocellular carcinoma is still poor, with a median overall survival of 7.6 months. Hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin is effective in large hepatocellular carcinoma or hepatocellular carcinoma with major portal vein tumor thrombus. Our previous showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab (programmed cell death protein-1 antibody) had a powerful anti-tumor effect for high-risk hepatocellular carcinoma, with a median overall survival of 18 months. Thus, the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus atezolizumab plus bevacizumab for patients with high-risk hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma

Keywords

High-risk hepatocellular Carcinoma; Hepatic arterial infusion chemotherapy; Oxaliplatin, 5-Fluorouracil and Leucovorin; Atezolizumab plus Bevacizumab

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 1.1 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

  30 days

Study Arms (1)

HAIC plus A+T

EXPERIMENTAL

Drug: Atezolizumab; Drug: Bevacizumab; Procedure: HAIC with FOLFOX

Interventions

Atezolizumab DRUG

1200 mg, iv.drip, Q3W

HAIC plus A+T

Bevacizumab DRUG

15mg/kg, iv.drip, Q3W

HAIC plus A+T

HAIC with FOLFOX PROCEDURE

administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries, Q3W

HAIC plus A+T

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.
• Barcelona clinic liver cancer-stage C
• High risk disease: Vp-4 based on the Japanese standard, bile duct invasion, or tumor occupancy ≥50% of the liver
• 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:
• 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

atezolizumab; Bevacizumab; Folfox protocol

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)

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

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: Professor

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 2, 2023
• Study Start: May 24, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 2, 2023

Record last verified: 2023-05

Locations

CN (1)