Advanced Hepatocellular CarcinomaNCT06644430
Ablation of Pulmonary Oligometastasis Combined With System for Advanced Hepatocellular Carcinoma
An observational study of Advanced Hepatocellular Carcinoma and Lung Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma, Lung Cancer, Oligometastasis
- What is being tested?
- Ablation and system therapy
- Type of treatment
- Surgery or procedure
- How many people
- 470 participants
- Where
- 1 siteChina
- Study dates
- 4 Oct 2024to 30 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- diagnosis of primary or recurrent HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- presence of pulmonary oligometastasis;
- metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;
- receipt of first-line systemic therapy for minimum of 3 months before ablation;
- undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) were included;
- classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
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- 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.
Who cannot join
- intermediate HCC;
- age < 18 years or > 75 years;
- advanced HCC with more than five metastases;
- no response to systemic therapy;
- metastases size > 5 cm;
- life expectancy less than 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General hospital
Beijing, Beijing Municipality, 100853
Qunfang Zhou, MD, 8619868000115, zhouqun988509@163.com
Feng Duan, MD, 8613910984586, duanfeng@vip.sina.com
About this study
Official title: Ablation of Pulmonary Oligometastasis Combined With System Compared System Therapy for Advanced Hepatocellular Carcinoma: a Multicenter Retrospective Study
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.
- Conditions
- Advanced Hepatocellular Carcinoma, Lung Cancer, Oligometastasis, Ablation, Systemic Therapy
- Being tested
- Ablation, system therapy
- Keywords
- Advanced hepatocellular carcinoma, Lenvatinib, Sorafeinib, Camrelizumab, Tislelizumab, Sintilimab, Toripalimab, Apatinib
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Ablation including (microwave ablation, radiofrequency ablation, cryoblation), this surgery was conducted under CT guidence. The pulmonary was completely ablated.
system therapyDrug
Paticipants received systemic therapy according the instructions.
| Study group | Role | What they receive |
|---|---|---|
| Ablation+system group | Participants received ablation of plumonary combined systemic therapy Receives: Procedure: Ablation; Drug: system therapy | |
| System group | Participants received systemic therapy Receives: Drug: system therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival
Progression was defined as progressive disease by independent radiologic review
Measured: 12 months
Secondary outcomes (2)
Overall survival (OS)
OS is the length of time from the date of inclusion until death from any cause.
Measured: 24 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start4 Oct 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Qunfang, Sun Yat-sen University
- Investigators
- Feng Duan, MD, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644430
- Sponsor's protocol ID
- CHEST-002
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided