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Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma

NCT ID: NCT06644430

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

470 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-04

Study Completion Date

2025-12-30

Brief Summary

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Ablation has been an effective therapy in treating intrathoracic metastases. However, for hepatocellular carcinoma with pulmonary oligometastasis, ablation of metastases remains relatively unexplored and still needs clinical evidence.

Detailed Description

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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. This multicenter study focuses on the management of ablation of oligometastasis therapy combined with systemic therapy.

Conditions

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Advanced Hepatocellular Carcinoma Lung Cancer Oligometastasis Ablation Systemic Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ablation+system group

Participants received ablation of plumonary combined systemic therapy

Ablation

Intervention Type PROCEDURE

Ablation including (microwave ablation, radiofrequency ablation, cryoblation), this surgery was conducted under CT guidence. The pulmonary was completely ablated.

system therapy

Intervention Type DRUG

Paticipants received systemic therapy according the instructions.

System group

Participants received systemic therapy

system therapy

Intervention Type DRUG

Paticipants received systemic therapy according the instructions.

Interventions

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Ablation

Ablation including (microwave ablation, radiofrequency ablation, cryoblation), this surgery was conducted under CT guidence. The pulmonary was completely ablated.

Intervention Type PROCEDURE

system therapy

Paticipants received systemic therapy according the instructions.

Intervention Type DRUG

Eligibility Criteria

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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;
2. presence of pulmonary 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 first-line systemic therapy for minimum of 3 months before 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) were included;
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. intermediate HCC;
2. age \< 18 years or \> 75 years;
3. advanced HCC with more than five metastases;
4. no response to Lenvatinib;
5. metastases size \> 5 cm;
6. life expectancy less than 3 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Zhou Qunfang

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Feng Duan, MD

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Locations

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Chinese PLA General hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qunfang Zhou, MD

Role: CONTACT

[email protected]
86 19868000115

Feng Duan, MD

Role: CONTACT

[email protected]
86 13910984586

Facility Contacts

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Qunfang Zhou, MD

Role: primary

[email protected]
8619868000115

Feng Duan, MD

Role: backup

[email protected]
8613910984586

Other Identifiers

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CHEST-002

Identifier Type: -

Identifier Source: org_study_id