Hepatocellular CarcinomaNCT06740370
TACE Combined With Lenvatinib and PD-1 Inhibitor for Ruptured Hepatocellular Carcinoma
A study testing TACE, Lenvatinib and PD-1 Inhibitors in people with Hepatocellular Carcinoma and Transcatheter Arterial Chemoembolization, run by Sun Yat-sen University at 1 site in China.
Trial summary
Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization, Anti-PD1 Antibody
- What is being tested?
- TACE, Lenvatinib and PD-1 Inhibitors
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 13 Dec 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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;
- presence of hemostasis in the enhanced CT scan;
- integrity of the tumor is disrupted and there is hematoma around the liver;
- receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
- transarterial artery chemoembolization (TACE) as local therapy;
- classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;
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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;
- non-ruptured HCC;
- Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
- age < 18 years or > 75 years;
- HCC with more than five metastases;
- History of hepatic encephalopathy and gastrointestinal bleeding
- 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
Qunfang Zhou
Beijing, None Selected, 100853
Qunfang Zhou, MD, 8619868000115, zhouqun988509@163.com
Feng Duan, MD, 8613910984586, duanfeng@vip.sina.com
About this study
Official title: TACE Combined With Lenvatinib and PD-1 Inhibitor for Spontaneous Rupture of Hepatocellular Carcinoma: a Prospective Multicenter Study
Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Then minimally therapy like transcatheter arterial chemoembolization (TACE) could effectively stanch the ruptured tumor and bleeding vessels. Then TACE combined the Lenvatinib and PD-1 inhibitor for this subtype HCC could effectively inhibit the tumor and improve the prognosis.
Read the detailed description
Spontaneous rupture of HCC is a life-threatening complication. HCC rupture is considerably higher in China. The tumor size in ruptured HCC is significantly greater than that in non-ruptured HCC. In the acute phase, hemostasis is the first concern and then tumor treatment is secondary. TACE can effectively induce hemostasis. Conservative treatment is usually system therapy for unresectable ruptured HCC. Thus, we conduct this multicenter single arm study to explore the efficacy, safety of TACE combined lenvatinib and PD-1 inhibitor for unresectable ruptured HCC. This study focuses on the efficacy of TACE combined with lenvatinib and PD-1 inhibitor as first-line therapy.
- Conditions
- Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization, Anti-PD1 Antibody, Lenvatinib
- Being tested
- TACE, Lenvatinib, PD-1 Inhibitors
- Keywords
- ruptured hepatocellular carcinoma, TACE, Lenvatinib, Tislelizumab, Sintilimab, Camrelizumab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure.
LenvatinibDrug
(12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day
PD-1 InhibitorsDrug
Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)
| Study group | Role | What they receive |
|---|---|---|
| TACE plus Lenvatinib and PD-1 inhibitor | Experimental | TACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days. Receives: Procedure: TACE; Drug: Lenvatinib; Drug: PD-1 Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free-Survival (PFS)
Progression was defined as progressive disease by independent radiologic review
Measured: 12 months
Secondary outcomes (2)
Objective response rate (ORR)
ORR, as determined based on tumor response according to mRECIST, is defined as the proportion of all included patients whose best overall response including complete response or partial response.
Measured: 12 months
Overall survival (OS)
OS is the length of time from the date of inclusion until death from any cause.
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 posted18 Dec 2024
- Study start13 Dec 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 32 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
- NCT06740370
- Sponsor's protocol ID
- Liver Projiect 14
- Status last verified
- Aug 2025
- First submitted
- 13 Dec 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TACE Combined With Lenvatinib and PD-1 Inhibitor for Spontaneous Rupture of Hepatocellular Carcinoma: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT06740370
- Acronym / sponsor ID
- Liver Projiect 14
- Conditions
- Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization, Anti-PD1 Antibody, Lenvatinib
- Keywords
- ruptured hepatocellular carcinoma, TACE, Lenvatinib, Tislelizumab, Sintilimab, Camrelizumab
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatocellular carcinoma (HCC) with spontaneous rupture is a potentially fatal complication and usually has poor prognosis. In most conditions, the tumors could not be radically moved. Then minimally therapy like transcatheter arterial chemoembolization (TACE) could effectively stanch the ruptured tumor and bleeding vessels. Then TACE combined the Lenvatinib and PD-1 inhibitor for this subtype HCC could effectively inhibit the tumor and improve the prognosis.
Detailed description
Spontaneous rupture of HCC is a life-threatening complication. HCC rupture is considerably higher in China. The tumor size in ruptured HCC is significantly greater than that in non-ruptured HCC. In the acute phase, hemostasis is the first concern and then tumor treatment is secondary. TACE can effectively induce hemostasis. Conservative treatment is usually system therapy for unresectable ruptured HCC. Thus, we conduct this multicenter single arm study to explore the efficacy, safety of TACE combined lenvatinib and PD-1 inhibitor for unresectable ruptured HCC. This study focuses on the efficacy of TACE combined with lenvatinib and PD-1 inhibitor as first-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE plus Lenvatinib and PD-1 inhibitor | Experimental | Procedure: TACE, Drug: Lenvatinib, Drug: PD-1 InhibitorsTACE was first performed, then Lenvatinib and PD-1 inhibitor were administered within seven days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;
- presence of hemostasis in the enhanced CT scan;
- integrity of the tumor is disrupted and there is hematoma around the liver;
- receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;
- transarterial artery chemoembolization (TACE) as local therapy;
Key exclusion criteria (7 listed)
- recurrent HCC;
- non-ruptured HCC;
- Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
- age < 18 years or > 75 years;
- HCC with more than five metastases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACETACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then a combination of lipiodol (5-15 ml), lobaplatin (30-50 mg), and Pirarubicin (30-50 mg) was infused into each tumor. We defined technical success as complete embolization of the tumor-feeding artery resulting in no tumor staining observed by angiogram at the end of procedure. | Procedure or surgery | TACE plus Lenvatinib and PD-1 inhibitor |
| Lenvatinib(12 mg (body weight ≥60 kg) , 8 mg (body weight <60 kg) orally once a day | Drug | TACE plus Lenvatinib and PD-1 inhibitor |
| PD-1 InhibitorsTislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks) | Drug | TACE plus Lenvatinib and PD-1 inhibitor |
Primary outcome
Progression-Free-Survival (PFS)
Time frame: 12 months
Progression was defined as progressive disease by independent radiologic review
2 secondary outcomes
Objective response rate (ORR)
Time frame: 12 months
Overall survival (OS)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Duan, MD study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TACE, Lenvatinib and PD-1 Inhibitors in people with Hepatocellular Carcinoma and Transcatheter Arterial Chemoembolization, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qunfang Zhou, MD (86 19868000115, zhouqun988509@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free-Survival (PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.