New treatment approach for advanced liver cancer using modified TOMOX-HAIC with immunotherapy
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 study is testing a new treatment that combines modified TOMOX-HAIC with immunotherapy to see if it helps people with advanced liver cancer feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | sintilimab, bevacizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06285019 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of a modified TOMOX-HAIC regimen combined with sintilimab and a bevacizumab biosimilar as a first-line treatment for patients with advanced hepatocellular carcinoma (HCC). The study is a single-center, single-arm phase II trial that aims to evaluate the overall response rate and other secondary endpoints such as disease control rate and overall survival. The trial builds on previous findings that suggest the combination of immunotherapy and targeted therapy can improve outcomes for HCC patients. Participants will receive the treatment and be monitored for their response and safety over the course of the study.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with histologically confirmed advanced hepatocellular carcinoma who are not candidates for radical surgery and have not received prior systemic treatment.
Not a fit: Patients with prior history of other malignancies, autoimmune diseases, or those with untreated bleeding varices may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced hepatocellular carcinoma.
How similar studies have performed: Previous studies have shown promising results with similar combinations of immunotherapy and targeted therapy in treating advanced hepatocellular carcinoma.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Lu Wang
- Email: cms024mm@163.com
- Phone: +86-18121299357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.