A Single-arm Clinical Study of HAIC Combined With Apatinib and Camrelizumab in the Treatment of Unresectable MTM HCC

• Status: Recruiting
• Trial end date: 2025-04-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-arm, open, multicenter II phase clinical study to compare the efficacy and safety of HAIC combined with Apatinib and Camrelizumab in the treatment of unresectable middle-advanced MTM-HCC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wan-Guang Zhang
• Treatments: Apatinib

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.