Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma

NCT ID: NCT06550921

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-08-30

Brief Summary

Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.

Detailed Description

Systemic therapy is the standard treatment for advanced hepatocellular carcinoma (HCC) with metastasis. However, metastases with limited number (oligometastasis) can represent a subtype and transition point between localized disease and widespread metastases. Thus, eliminating metastases could be advantageous and beneficial to the prognosis if feasible and permitted. Image-guided ablation therapy, such as microwave ablation (MWA), radiofrequency ablation (RFA), and cryoablation, has attracted great interest as a minimally invasive approach against intrathoracic metastases. Recently, ablation has been used on patients with pulmonary metastases from various cancers. This technique yields high proportions of sustained complete responses and is associated with relatively low morbidity. Thus, we conduct this multicenter single arm study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with metastases-directed ablation in advanced HCC. This study focuses on the management of ablation of oligometastasis therapy combined with lenvatinib and PD-1 inhibitor. This study aims to evaluate the survival benefits of ablating oligometastasis for advanced HCC.

Conditions

Advanced Hepatocellular Carcinoma; Oligometastasis; Ablation; Anti-PD1 Antibody; Lenvatinib

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ablation-Len-PD-1 inhibitor

ablation of oligometastasis therapy combined with lenvatinib and PD-1 inhibitor

Group Type: EXPERIMENTAL

ablation of oligometastasis

Intervention Type: PROCEDURE

The oligometastasis of hepatocellular carcinoma are ablation completely by ablation (including microwave ablation, radiofrequency ablation, and cryoablation)

Interventions

ablation of oligometastasis

The oligometastasis of hepatocellular carcinoma are ablation completely by ablation (including microwave ablation, radiofrequency ablation, and cryoablation)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases 20;

2. presence of oligometastasis, the metastases found within three month of HCC diagnosis;

3. metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;

4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy for a minimum of 3 months before study ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST);

5. undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC);

6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;

7. no history of other malignancies.

8. life expectancy more than 3 months;

9. agreed to participated in this clinical trial;

10. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

Exclusion Criteria

1. recurrent HCC;

2. advanced HCC Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;

3. age < 18 years or > 75 years;

4. advanced HCC with more than five metastases;

5. no response to Lenvatinib;

6. metastases size > 5 cm;

7. life expectancy less than 3 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhou Qunfang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Duan, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Chinese PLA General hospital

Beijing, None Selected, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qunfang Zhou, MD

Role: CONTACT

zhouqun988509@163.com

86 19868000115

Feng Duan, MD

Role: CONTACT

duanfeng@vip.sina.com

86 13910984586

Facility Contacts

Qunfang Zhou

Role: primary

zhouqun988509@163.com

Feng Duan

Role: backup

duanfeng@vip.sina.com

8613910984586

Other Identifiers

Liver Projiect 8

Identifier Type: -

Identifier Source: org_study_id