Efficacy and Safety of Modified Hepatic Artery Infusion Chemotherapy (TOMOX-HAIC) in Combination With Sintilimab and Bevacizumab Biosimilar for the First-line Treatment of Advanced Hepatocellular Carcinoma: a Prospective, Single-arm, Phase II Clinical Study

GWK-2023-004

This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.

2023-12-01

2024-12-31

2025-12-31

Recruiting

Early phase I

65

Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial. * Males or unpregnant females who age ≥ 18 years, ≤75 years. * The investigator believes the patient is capable of complying with the study protocol. * Histologically, cytologically or clinically confirmed advanced hepatocellular carcinoma. * is not a candidate for radical surgery * not received previous systemic treatment * patients must have at least one measurable lesion (RECIST 1.1) * ECOG PS：0-1, 14 days before enrollment * Child-Pugh A or Child-Pugh B ≤ 7, 14 days before enrollment Exclusion Criteria: * Prior history of other malignant tumors * Current or prior immunodeficiency disorders or autoimmune diseases * Subjects have untreated or incompletely treated esophageal and/or gastric varices with bleeding or high risk of bleeding * Subjects who are not available for follow-up or are participating in other clinical trials that have the potential to interfere with this study * Conditions considered unsuitable for inclusion by researchers

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 65, 'type': 'ESTIMATED'}}

2024-02-29