Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Tislelizumab

Immunoglobulins

Immunologic Factors

Antineoplastic Agents, Immunological

Patients who meet the inclusion criteria will receive 1 cycle of PD-1 antibody on the day before ablation, then 3 cycles of PD-1 antibody after primary radiofrequency or microwave ablation, on a schedule of per 3 weeks, then be followed until disease relapse or death.

The enrolled patients received intravenous injections of PD-1 monoclonal antibody (Tislelizumab 200mg) on the 1 day before radiofrequency or microwave ablation treatment, and 21(±7) days, 42(+7) and 63(+7) after ablation.

PD-1 monoclonal antibody

The enrolled patients received primary radiofrequency or microwave ablation on the day after the first dose of PD-1 antibody treatment.

Radiofequencey or microwave ablation

Min-Shan Chen, Ph.D.

Li Xu

minshan chen, M.D.

yaojun zhang, M.D.

This is a Phase 2, single arm, single center study designed to evaluate the safety and tolerability of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with hepatocellular carcinoma(HCC), with the secondary study objective to preliminarily evaluate the efficacy of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with HCC and the exploratory study objective to evaluate the effect of ablation combined with PD-1 monoclonal antibody on immune function and hepatitis virus infection status in patients with HCC. This study will be divided into two stages, and the first stage is to enroll 6 patients for dose-limited toxicity (DLT) observation. If DLT appeared in \< 2 patients, the second stage was entered and the other 24 patients were further enrolled.

The enrolled patients received intravenous injection of PD-1 monoclonal antibody (tirelizumab 200mg) on the day before ablation and the 21 (± 7) days, the 42 (+ 7) days and the 63 (+ 7) days after ablation, respectively (a total of 4 times). Liver tumor biopsy was performed during ablation, tissue samples will be stored for pathological examination and test of PD-L1 expression.

Liver enhanced MRI or CT and contrast-enhanced ultrasound were reviewed within 4 \~ 6 weeks after the first ablation treatment to evaluate the complete response rate of the tumor after treatment. Patients suspected of local incomplete ablation in either of the two examinations could receive a salvage ablation for once within 12 weeks of the first ablation, but no extra dose of PD-1 antibody would be given. Patients with residual viable tumor after re-ablation were defined as treatment failure.

The first six patients (stage I) underwent detailed physical examination on the 2nd, 7th, 14th and 21st days after receiving the first dose of study drug, and 30 days after the 2nd and 4th doses of study drugs. Blood tests and urine routine were performed on the 2nd day after treatment, as well as ECG examination. In the second stage, the patients underwent examinations on the second and 21st days after the dose of study drug, and on the 30 days after the last dose of study drug (the above examination can be carried out within ± 7 days). If there are clinically significant study related adverse events (including abnormal test results) in patients in stage I, necessary reexamination and visit would be added in patients in stage II.

Radiological evaluation arrangement: liver enhanced MRI or CT and contrast-enhanced ultrasound were performed within 4 \~ 6 weeks after the first ablation. The second imaging examination would be completed within 4 \~ 6 weeks after the end of the study treatment, and then examined according to the following schedule: CT / MRI was repeated every 3 months within the first year, then every 4 months within the next year, and every 6 months after 2 years. The investigators will evaluate the adverse events during the follow-up. After the patients have radiologically confirmed recurrence and/or metastasis, they will be treated according to the guideline without limitation. The information of all anti-cancer treatments they received need to be collected.

Follow-up by phone will be conducted at least every 6 months until death to find out the patient's survival data, as well as their physical condition and information about other anticancer treatment received.

Evaluate the safety and tolerability of radiofrequency ablation combined with PD-1 monoclonal antibody in the treatment of patients with hepatocellular carcinoma.

Ablation Combined With PD-1 in HCC: Phase II Study

Phase II Study of Ablation Combined With PD-1 Antibody in Patients With Hepatocellular Carcinoma

Will share the data on https://www.researchdata.org.cn/default.aspx.

Treatment-related adverse events (TRAEs) and serious adverse events (SAEs) occurring from the start of PD-1 monoclonal antibody therapy to 90 days after treatment were observed and judged according to CTCAE 5.0 criteria.

Measured as the rate of patients able to complete treatment as planned in the study.

Complete response rate of single ablation combined with PD-1 monoclonal antibody in patients with hepatocellular carcinoma

Rate of treatment failure (rate of patients with lesions residue after first ablation and tumor survival after re-ablation)

1- and 2-year local recurrence rate (LRR) and distant metastasis rate (DMR) after ablation

The percentage of patients who were without disease or still alive at the 1- and 2-year time point since the first cycle of treatment. The end point of observation is death due to tumor.

median disease-free survival of patients after ablation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ablation Combined With PD-1 in HCC: Phase II Study	NCT04652440	Hepatocellular ...	PD-1 monoclonal... Radiofequencey ...	18 Years - 75 Years	Sun Yat-sen University
Ablation Combined With PD-1 in HCC: Phase II Study	NCT04652440	Hepatocellular ...	PD-1 monoclonal... Radiofequencey ...	18 Years - 75 Years	Sun Yat-sen University

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