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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Lu Wang
cms024mm@163.com
+86-18121299357
Time Frame
Start Date: 2023-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 65
Treatments
Experimental: Combination therapy
TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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