Advanced Hepatocellular CarcinomaNCT06550921
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma
A study testing ablation of oligometastasis in people with Advanced Hepatocellular Carcinoma and Oligometastasis, run by Sun Yat-sen University at 1 site in China.
Trial summary
Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma, Oligometastasis, Ablation
- What is being tested?
- ablation of oligometastasis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Aug 2027
- Phase
- Interventional
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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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
- 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.
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, None Selected, 100853
Qunfang Zhou, zhouqun988509@163.com
Feng Duan, 8613910984586, duanfeng@vip.sina.com
About this study
Official title: Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma: A Multicenter, Prospective, Phase II Study
Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.
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. 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
- Being tested
- ablation of oligometastasis
- Keywords
- Lenvatinb, Tislelizumab, Sintilimab, Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablation of oligometastasisProcedure or surgery
The oligometastasis of hepatocellular carcinoma are ablation completely by ablation (including microwave ablation, radiofrequency ablation, and cryoablation)
| Study group | Role | What they receive |
|---|---|---|
| Ablation-Len-PD-1 inhibitor | Experimental | ablation of oligometastasis therapy combined with lenvatinib and PD-1 inhibitor Receives: Procedure: ablation of oligometastasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival (PFS)
Progression-Free-Survival (PFS)
Measured: 24 months
Secondary outcomes (3)
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 (BOR) is either a complete response or partial response.
Measured: 12 months
Adverse events
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Aug 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion30 Aug 2027 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital
- Responsible party
- Principal investigator, Zhou Qunfang, Sun Yat-sen University
- Investigators
- Feng Duan, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550921
- Sponsor's protocol ID
- Liver Projiect 8
- Status last verified
- Aug 2024
- First submitted
- 8 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No