Treatment for unresectable macrotrabecular massive liver cancer using HAIC, Apatinib, and Camrelizumab

A Single-arm, Exploratory Clinical Study of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Apatinib and Camrelizumab in the Treatment of Unresectable Macrotrabecular-massive Hepatocellular Carcinoma

This study is testing a new treatment combining chemotherapy and two medications for people with a tough-to-treat type of liver cancer that can't be removed with surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji Hospital (other)
• Drugs / interventions: chemotherapy, Camrelizumab, Apatinib
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05839197 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) combined with Apatinib and Camrelizumab in patients with unresectable macrotrabecular massive hepatocellular carcinoma (MTM-HCC). It is a single-arm, open-label, multicenter Phase 2 study involving 38 untreated patients. The treatment involves administering standard HAIC followed by Camrelizumab for eligible patients based on liver function. The goal is to provide a new treatment option for this aggressive form of liver cancer, which currently lacks validated therapies.

Who should consider this trial

Good fit: Ideal candidates are patients with newly diagnosed unresectable macrotrabecular massive hepatocellular carcinoma who have not received prior treatment.

Not a fit: Patients with Child-Pugh liver function class C or those with prior treatment for hepatocellular carcinoma 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 unresectable MTM-HCC.

How similar studies have performed: Previous studies have shown promising results with HAIC and the combination of Apatinib and Camrelizumab, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Macrotrabecular Massive HCC diagnosed by histopathology or cytology according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022 Edition);
* Stage Ⅰa\~Ⅱb and up-to-seven（tumor number +tumor size≥7) OR stage Ⅲa according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer in China (2022 Edition);
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; expected survival ≥ 12 weeks;
* Child-Pugh liver function class A-B7
* Patients with newly diagnosed hepatocellular carcinoma who have not received any local or systemic treatment for hepatocellular carcinoma;
* At least one measurable lesion (according to RECIST1.1 standard); its diameter ≥ 1cm was accurately measured by magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement, and the target lesion had not received local treatment in the past (including not limited to hepatic arterial Infusion chemotherapy, radiofrequency ablation, argon-helium knife, radiotherapy, etc.);
* No serious organic diseases of heart, lung, brain and other organs;

Exclusion Criteria:

* Women who are pregnant (positive for pre-medication pregnancy test) or breastfeeding
* Participated in clinical trials of other antineoplastic drugs within 4 weeks before entering the group.
* Received any surgery or invasive treatment or operation (except venous catheterization, puncture and drainage, etc.) within 4 weeks before the start of the group;
* History of previous immune and targeted therapy for HCC;
* Patients who have previously received organ transplants or planned organ transplants;
* Significant clinical gastrointestinal bleeding or a potential risk of bleeding was identified by the investigator during the 30 days prior to study entry.
* Active or uncontrolled severe infection (≥ （Common Terminology Criteria for Adverse Events）CTCAE 2 grade infection);
* Suffered from other malignant tumors in the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ;
* Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the researchers, there is reason to suspect that the patient has a disease or state that is not suitable for the use of research drugs (such as having seizures and requiring treatment), or will affect the interpretation of the results of the study, or put the patient at high risk;
* The researchers judged that patients have other factors that may affect the results of the study or lead to the termination of the study, such as alcohol abuse, drug abuse, and other serious diseases (including mental illness) that need to be combined with treatment. there are serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of patients.

Where this trial is running

Wuhan, Hubei

• Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)

Study contacts

• Principal investigator: Wanguang Zhang, M.D.,Ph.D. Wanguang Zhang, M.D.,Ph.D., M.D.,Ph.D. — Medical Ethics Committee of Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
• Study coordinator: Wanguang Zhang, M.D.,Ph.D.

Conditions: Macrotrabecular Massive Hepatocellular Carcinoma, HAIC, Camrelizumab, Apatinib