Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285019
• Other study ID #: GWK-2023-004
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Fudan University
• Contact: Lu Wang
• Phone: +86-18121299357
• Email: cms024mm[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors worldwide.The IMbrave150 study and the Orient-32 study demonstrated that PD-1 in combination with bevacizumab confers better survival outcomes in advanced hepatocellular carcinoma. In addition, HAIC combined with targeted therapy and immunotherapy has shown good safety and encouraging efficacy. Oxaliplatin-based FOLFOX regimen is currently the mainstream HAIC chemotherapy regimen (FOLFOX HAIC) in China.

The results of the previous study confirmed that raltitrexed shows promising antitumor activity and safety in hepatocellular carcinoma. Also, TOMOX-HAIC regimen can significantly shorten the infusion duration and is expected to improve the patient experience, quality of life, and adherence while ensuring the efficacy.

In this clinical trial, patients will receive TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar. The primary endpoint is overall response rate. The secondary endpoint are disease control rate, time to progression, duration of response, overall survival, and safety

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• TOMOX-HAIC
Oxaliplatin 85mg/m^2 plus Raltitrexed 3mg/m^2, 21 days for a cycle

Drug:
• Sintilimab
200mg, ivgtt, d1, 21 days for a cycle
• Bevacizumab
7.5mg/kg, ivgtt, d1, 21 days for a cycle

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate (ORR)	ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. and mRECIST	24 months
Secondary	disease control rate (DCR)	DCR was defined as the percentage of participants who have a confirmed complete response(CR) or partial response(PR) or stable disease(SD) per RECIST 1.1 and mRECIST as assessed by investigator	24 months
Secondary	Progression-Free Survival (PFS)	PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and mRECIST as assessed by investigator	24 months
Secondary	Time to progression (TTP)	the time from randomization until first evidence of disease progression	24 months
Secondary	Duration of response (DOR)	defined as the time from randomization to disease progression or death in patients who achieve complete or partial response	24 months
Secondary	overall survival (OS)	OS is the time from enrollment to death due to any cause.	24 months
Secondary	adverse event (AE)	using the The NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)	24 months