Clinical trial NCT06285019: Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: objective response rate (ORR)
timeFrame: 24 months
Secondary outcomes:
measure: disease control rate (DCR)
timeFrame: 24 months
measure: Progression-Free Survival (PFS)
timeFrame: 24 months
measure: Time to progression (TTP)
timeFrame: 24 months
measure: Duration of response (DOR)
timeFrame: 24 months
measure: overall survival (OS)
timeFrame: 24 months
measure: adverse event (AE)
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References: