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Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma
RECRUITINGPhase 2Sponsored by Fudan University
Actively Recruiting
PhasePhase 2
SponsorFudan University
Started2023-12-01
Est. completion2024-12-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06285019
Summary
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.
Eligibility
Age: 18 Years – 75 YearsHealthy volunteers accepted
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
Conditions4
CancerHepatocellular CarcinomaLiver CancerLiver Disease
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Actively Recruiting
PhasePhase 2
SponsorFudan University
Started2023-12-01
Est. completion2024-12-31
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06285019