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

NCT06550921 | Recruiting

• 1 other identifier: Liver Projiect 8
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Lenvatinb; Tislelizumab; Sintilimab; Camrelizumab

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival (PFS)

  Progression-Free-Survival (PFS)

  24 months

Secondary Outcomes (3)

• Overall survival (OS)

  24 months

• Objective response rate (ORR)

  12 months

• Adverse events

  24 months

Study Arms (1)

Ablation-Len-PD-1 inhibitor

EXPERIMENTAL

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

Procedure: ablation of oligometastasis

Interventions

ablation of oligometastasis PROCEDURE

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

Ablation-Len-PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases 20;
• presence of oligometastasis, the metastases found within three month of HCC diagnosis;
• metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;
• 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);
• undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC);
• classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• no history of other malignancies.
• life expectancy more than 3 months;
• agreed to participated in this clinical trial;
• 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.

You may not qualify if:

• recurrent HCC;
• advanced HCC Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
• age \< 18 years or \> 75 years;
• advanced HCC with more than five metastases;
• no response to Lenvatinib;
• metastases size \> 5 cm;
• life expectancy less than 3 months.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Chinese PLA General hospital

Beijing, None Selected, 100853, China

RECRUITING

Study Officials

• Feng Duan, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.com

Feng Duan, MD

CONTACT

86 13910984586; duanfeng@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 13, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)