Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma
NCT ID: NCT06285019
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
65 participants
INTERVENTIONAL
2023-12-01
2025-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Combination therapy
TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar
TOMOX-HAIC
Oxaliplatin 85mg/m\^2 plus Raltitrexed 3mg/m\^2, 21 days for a cycle
Sintilimab
200mg, ivgtt, d1, 21 days for a cycle
Bevacizumab
7.5mg/kg, ivgtt, d1, 21 days for a cycle
Interventions
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TOMOX-HAIC
Oxaliplatin 85mg/m\^2 plus Raltitrexed 3mg/m\^2, 21 days for a cycle
Sintilimab
200mg, ivgtt, d1, 21 days for a cycle
Bevacizumab
7.5mg/kg, ivgtt, d1, 21 days for a cycle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Lu Wang, MD, PhD
Director of Hepatobiliary Surgery
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GWK-2023-004
Identifier Type: -
Identifier Source: org_study_id
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