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

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

NCT ID: NCT05886465

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Atezolizumab

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

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Atezolizumab
Description: 1200 mg, iv.drip, Q3W
Arm group label: HAIC plus A+T

Intervention type: Drug
Intervention name: Bevacizumab
Description: 15mg/kg, iv.drip, Q3W
Arm group label: HAIC plus A+T

Intervention type: Procedure
Intervention name: HAIC with FOLFOX
Description: administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries, Q3W
Arm group label: HAIC plus A+T

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.

Criteria for 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. - 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 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Center Sun Yat-sen University

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Contact:
Last name: Ming Shi, MD

Phone: 8620-87343115
Email: shiming@mail.sysu.edu.cn

Start date: May 24, 2023

Completion date: December 1, 2024

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05886465