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RecruitingNCT06644430Updated Dec 3, 2024

Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma

An observational study in Advanced Hepatocellular Carcinoma, Lung Cancer and Oligometastasis, sponsored by Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Sun Yat-sen University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
470
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

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

02

Conditions studied

  • Advanced Hepatocellular Carcinoma
  • Lung Cancer
  • Oligometastasis
  • Ablation
  • Systemic Therapy

Keywords

  • Advanced hepatocellular carcinoma
  • Lenvatinib
  • Sorafeinib
  • Camrelizumab
  • Tislelizumab
  • Sintilimab
  • Toripalimab
  • Apatinib
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 470 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Thermal ablation, as a minimal therapy, has been recommended as a favorable therapy for metastases worldwide. However, for advanced hepatocellular carcinoma with pulmonary oligometastasis, the standard of care is system therapy. However, the evidence of ablating the oligometastasis is limited. In this multicenter study, we want to indicate that compared with systemic therapy, patients received thermal ablation of pulmonary oligometastasis plus system therapy showed significantly longer survival. This study will supplement the current situation where system therapy is the standard of care for hepatocellular carcinoma with oligometastasis.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
470 participants (estimated)
Patient registry
No

Groups and cohorts

  • Ablation+system group

    Participants received ablation of plumonary combined systemic therapy

    Procedure: Ablation · Drug: system therapy

  • System group

    Participants received systemic therapy

    Drug: system therapy

Interventions

  • ProcedureAblation

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

  • Drugsystem therapy

    Paticipants received systemic therapy according the instructions.

06

What researchers measure

Primary outcomes

  1. Progression-Free-Survival

    Progression was defined as progressive disease by independent radiologic review

    Time frame: 12 months

Secondary outcomes

  1. Overall survival (OS)

    OS is the length of time from the date of inclusion until death from any cause.

    Time frame: 24 months

  2. Objective response rate (ORR)

    ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response is either a complete response or partial response.

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06644430
Lead sponsor
Sun Yat-sen University
Responsible party
Zhou Qunfang (Clinical Professor, Sun Yat-sen University) — Principal investigator
First posted
Oct 16, 2024
Start date
Oct 4, 2024
Primary completion
Jun 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Dec 3, 2024

Study contacts

Qunfang Zhou, MD
Contact
zhouqun988509@163.com
86 19868000115
Feng Duan, MD
Contact
duanfeng@vip.sina.com
86 13910984586
Feng Duan, MD
study director · Chinese PLA General Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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