Neoplasms

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Digestive System Diseases

Heart and Blood Diseases

Carcinoma

Carcinoma, Hepatocellular

Embolism

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

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Antibodies

Antibodies, Monoclonal

Lenvatinib

Angiogenesis Inhibitors

Epirubicin

Immunomodulating Agents

Immunoglobulins

Chlorotrianisene

Protein Kinase Inhibitors

Enzyme Inhibitors

The participants will receive the combined treatment of immunotherapy (PD-1 monoclonal antibody), local therapy (TACE, lobaplatin and epirubicin and anti-angiogenic therapy (lenvatinib)

the combination of immunotherapy (PD-1 monoclonal antibody), local therapy (TACE) and anti-angiogenic therapy (lenvatinib)

PD-1 mAb combined with TACE and lenvatinib

Ti Zhang, MD

Wei Lu, MD

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.

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.

This study focuses on the in-operable, middle and late stage (BCLC-B and BCLC-C) HCC patients. The participants will receive the combined treatment of immunotherapy (PD-1 monoclonal antibody), local therapy (TACE) and anti-angiogenic therapy (lenvatinib).

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

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

The ratio of patients with locally advanced liver cancer who could not be operated on before to get radical operation through comprehensive treatment

The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR = CR + PR

Progression free survival period refers to the period from the beginning of treatment to the time when patients with cancer progress is observed or death occurs for any reason.

Time from the beginning of treatment to the objective progression of tumor

It is the sum of the proportion of complete response (CR), partial response(PR) and stable disease(SD). That is, DCR = CR + PR + SD

the time from the first evaluation of the tumor as CR or PR to the first evaluation as PD or any cause of death

the time from the beginning of treatment to death caused by any reason (the last follow-up time is for the patients who lost the visit; the end of the study is for the patients who are still alive)

Tianjin Medical University Cancer Institute and Hospital

Oxaliplatin

Sorafenib

The participants will receive the combined treatment of local therapy (TACE, oxaliplatin and epirubicin), anti-angiogenic therapy (sorafenib), and immunotherapy (PD-1 monoclonal antibody)

the combination of local therapy (TACE), anti-angiogenic therapy (sorafenib), and immunotherapy (PD-1 monoclonal antibody)

TACE combined with sorafenib and PD-1 mAb

Guohui Xu

Xuegang Yang

Hepatocellular carcinoma (HCC) is the fourth most common cause of cancer-related death that ranks sixth in terms of incident cases, with an overall 5 years survival of 18%. Despite a significant improvement in treatment strategy, the overall survival of HCC remains low due to high recurrence, progressive liver dysfunction and the high fatality of the disease. Surgical resection has been applied in a number of patients; however, surgery has been associated with a high incidence of recurrence (approximately 70% within 5 years). TACE is generally applied on intermediate-stage HCC. However, TACE is not satisfied with improving overall survival. 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, BCLC-B/C HCC patients. Through the combination of local therapy (TACE), anti-angiogenic therapy (Sorafenib), and immunotherapy (PD-1 monoclonal antibody), 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 BCLC-B/C HCC.

This study is a single arm, single center, open label study. It is estimated that 60 patients with BCLC-B/C 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 200 mg of PD-1 monoclonal antibody, intravenous infusion on the first day, every 21 days as a treatment cycle; mesylate sorafenib, 400 mg, oral twice a day, continuous oral; TACE, the lipiodol + blank microspheres and oxaliplatin (100 mg) + epirubicin (50 mg) were injected into the hepatic artery by routine procedure, repeated every 4-6 weeks, and administered for according to the physician in charge, TACE treatment 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 4-6 weeks since the first administration, and every 12 weeks (± 7 days) after 24 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.

This study focuses on the in-operable, BCLC-B/C stage HCC patients. The participants will receive the combined treatment of local therapy (TACE) , anti-angiogenic therapy (sorafenib), and immunotherapy (PD-1 monoclonal antibody)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of HCC	NCT04273100	Hepatocellular ...	PD-1 mAb combin...	18 Years -	Tianjin Medical University Cancer Institute and Hospital
TACE, Sorafenib and PD-1 Monoclonal Antibody in the Treatment of HCC	NCT04518852	Hepatocellular ... Liver Neoplasms Digestive Syste... Sorafenib Molecular Mecha... Liver Diseases Antineoplastic ... Protein Kinase ...	TACE combined w...	18 Years -	Sichuan Cancer Hospital and Research Institute

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