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

February 22, 2024 updated by: Lu Wang, MD, PhD, Fudan University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200062
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination therapy
TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar
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
Drug: Bevacizumab
7.5mg/kg, ivgtt, d1, 21 days for a cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate (ORR)
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: 24 months
OS is the time from enrollment to death due to any cause.
24 months
disease control rate (DCR)
Time Frame: 24 months
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
Progression-Free Survival (PFS)
Time Frame: 24 months
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
Time to progression (TTP)
Time Frame: 24 months
the time from randomization until first evidence of disease progression
24 months
Duration of response (DOR)
Time Frame: 24 months
defined as the time from randomization to disease progression or death in patients who achieve complete or partial response
24 months
adverse event (AE)
Time Frame: 24 months
using the The NCI Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 22, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GWK-2023-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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