PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of HCC — PLTHCC  

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title: PD-1 mAb Combined With Lenvatinib and TACE in the Treatment of BCLC B/C Hepatocellular Carcinoma: Single Arm, Single Center, Non Randomized, Open Label Study

Status Recruiting

Clinical Trial Summary

The vast majority of primary liver cancer (90%) is hepatocellular carcinoma (HCC), and the majority of HCC patients have been locally advanced or metastatic disease when they are diagnosed in clinics. Most of them are not suitable for radical treatment. In the case of supportive treatment, the median survival time was only 7.9 months. Therefore, there is an urgent need for effective treatment for these patients.

At present, the overall objective response rate (ORR) of single or sequential therapy is not satisfied, and the over survival (OS) improvement is not ideal. Therefore, combined therapy maybe the good choice for patients with advanced HCC.

This study focuses on the in-operable, middle and late stage (BCLC-B and BCLC-C) HCC patients. Through the combination of immunotherapy (PD-1 monoclonal antibody), local therapy (TACE) and anti-angiogenic therapy (lenvatinib), it is expected to change the tumor microenvironment, restore the immune response, strengthen the anti-tumor effect of various treatments, and improve the therapeutic efficacy in patients with middle and late stage HCC.

Clinical Trial Description

This study is a single arm, single center, non randomized, open label study. It is estimated that 56 patients with advanced HCC who can not receive radical resection will be enrolled.

The trial period of subjects includes screening period, treatment period and follow-up period.

The drug treatment was 240 mg of PD-1 monoclonal antibody, intravenous infusion on the first day, every 21 days as a treatment cycle; lenvatinib mesylate capsule, 12 mg (body weight ≥ 60 kg) or 8 mg (body weight < 60 kg), oral once a day, continuous oral; TACE, the blank microspheres and lobaplatin (30 mg) + epirubicin (40 mg) were injected into the hepatic artery by routine procedure, repeated every 4-6 weeks, and administered for 2-4 cycles. Treatment continues until the disease progresses, intolerable toxicity occurs, new anti-tumor treatment is started, informed consent is withdrawn, follow-up is lost, death occurs or treatment termination is required。

Screening will be performed between days - 21 and - 4. Informed consent was signed up to 4 weeks prior to the first day of cycle 1 before any screening procedure or evaluation was performed and the trial was fully explained to each subject.

Baseline evaluation results must be collected prior to the first trial drug administration (day 1 of cycle 1). Baseline assessments may be performed between days - 3 and - 1 or on day 1 of cycle 1. If performed within 3 days before the first day of cycle 1, the screening results can be used as baseline results.

The tumor imaging was evaluated every 8 weeks (± 7 days) since the first administration, and every 12 weeks (± 7 days) after 36 weeks. If there are clinical indications for disease progression, tumor evaluation is more frequent. In the event of disease progression, unacceptable toxicity, the subject's request to discontinue the trial or the subject's withdrawal of consent, the subject will discontinue the trial treatment.

When the trial treatment is stopped, the treatment visit shall be stopped within 7 days after the treatment is stopped in order to stop the treatment examination.

After the end of the treatment period (up to 2 years), subjects who can benefit from the study drug will continue to study the treatment of the drug until disease progression, intolerable adverse reactions, withdrawal of intensive care facility (ICF), other anti-tumor treatment, loss of follow-up, death or termination of the study.

After the occurrence of a clinical event, if it is judged by the investigators that it should be attributed to the progress of the disease and it is unlikely to recover even if the patient continues to receive treatment, it can be evaluated as clinical deterioration. It is up to the investigator to discuss and decide whether to continue or stop the treatment for the subject and record in the study file.

At the end of the study, subjects who are still under study treatment can continue to receive treatment through another extended study or other forms at the discretion of the investigator if they are stable or relieved in the efficacy evaluation and can tolerate the adverse reactions. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

• NCT number: NCT04273100
• Study type: Interventional
• Source: Tianjin Medical University Cancer Institute and Hospital
• Status: Recruiting
• Phase: Phase 2
• Start date: November 14, 2019
• Completion date: June 30, 2021