Carcinoma, HepatocellularNCT06794073
Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study
A study testing Multimodal Thermal Therapy in people with Carcinoma, Hepatocellular and Neoplasms, Glandular and Epithelial, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Adenocarcinoma
- What is being tested?
- Multimodal Thermal Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2026to 31 Aug 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years, regardless of gender.
- Clinically or pathologically confirmed HCC.
- CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.
- Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor >5 cm.
- Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment..
- ECOG PS 0-1 and an expected survival >3 months.
- Child-Pugh score ≤7.
Who cannot join
- Child-Pugh class C liver dysfunction.
- Tumor thrombus in the main portal vein or hepatic vein.
- Extensive metastatic disease with an expected survival <3 months.
- Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).
- History of esophageal/gastric variceal bleeding within the past month.
- History of other malignancies.
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- Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within <1 month.
- Active infection; HBV co-infection (HBV DNA ≥2000 IU/mL or ≥10⁴ copies/mL unless reduced by one log after antiviral therapy); HCV co-infection requiring guideline-directed antiviral treatment; HIV infection; or biliary tract inflammation.
- History of organ transplantation or hepatic encephalopathy.
- Uncorrectable coagulation disorders.
- Refractory massive ascites, pleural effusion, or cachexia.
- Pregnancy, impaired consciousness, or inability to comply with treatment.
- High tumor burden (sum of the largest liver lesion diameter and number of liver lesions >12).
- Any other condition deemed unsuitable by investigators that may affect study participation.
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
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Minjie Yang, +86 02164041990, yang.mingjie@zs-hospital.sh.cn
About this study
This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.
Read the detailed description
This study aims to evaluate the efficacy and safety of multimodal ablation combined with Tislelizumab, lenvatinib, and TACE in the treatment of primary liver cancer. By comparing preoperative and postoperative immune markers, the study seeks to clarify the clinical value of multimodal ablation combined with systemic therapy and TACE in the management of primary liver cancer.
- Conditions
- Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Adenocarcinoma, Digestive System Neoplasms, Liver Neoplasms
- Being tested
- Multimodal Thermal Therapy
- Keywords
- Multimodal, Tislelizumab, lenvatinib, TACE, unresectable primary liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Adenocarcinoma, Digestive System Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Thermal TherapyDevice
The high-burden tumor is identified as the target lesion for treatment. A pre-treatment biopsy of the target lesion is performed to obtain tumor tissue. Multimodal ablation therapy of the target lesion is conducted under CT guidance. The treatment procedure follows the tumor ablation protocol using the multimodal therapy radiofrequency temperature-controlled mode.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The patient will receive induction therapy with tislelizumab and lenvatinib within 14 days after enrollment. Subsequently, within 2-7 days (the exact timing will be determined based on clinical circumstances), they will undergo Multimodal Thermal Therapy (MTT). Following the MTT procedure, on-demand TACE treatment will be administered. Starting from day 7 post-MTT (with the exact timing adjusted according to clinical conditions), the patient will resume tislelizumab and lenvatinib therapy until disease progression, occurrence of intolerable toxicity, or withdrawal of consent. Receives: Device: Multimodal Thermal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) according to RECIST 1.1 and mRECIST
Refers to the proportion of patients whose tumors shrink to a certain extent and maintain that response for a specified period, including cases of Complete Response (CR) and Partial Response (PR). Tumor objective response is assessed using RECIST 1.1 and mRECIST criteria. At baseline, subjects must have measurable tumor lesions. According to the efficacy evaluation criteria, the outcomes are classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
Measured: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.
Secondary outcomes (3)
Progression-Free Survival（PFS）
It refers to the time from the date of enrollment to the date of the first recorded disease progression(PD)or death,whichever occurs first.
Measured: Follow-up for 12 months,with assessments conducted every 3 months.
Overall Survival（OS）
Overall Survival(OS)refers to the time from the date of enrollment to the date of death due to any cause.
Measured: Follow-up for 12 months,with assessments conducted every 3 months.
Safety and Tolerability
Safety:Refers to the extent to which a drug does not cause unacceptable harm or side effects when applied in the human body.Tolerability:Refers to the degree to which patients accept the side effects that occur after treatment,reflecting their ability to endure the side effects of the medication.All adverse events will be recorded and assessed for severity based on the NCI-CTC AE 5.0 grading criteria.During the follow-up period,all subjects will be continuously monitored,and the occurrence,duration,severity,and treatment-relatedness of adverse events will be documented.
Measured: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start31 Jan 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794073
- Sponsor's protocol ID
- MTT-B2024
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study
- ClinicalTrials.gov ID
- NCT06794073
- Acronym / sponsor ID
- MTT-B2024
- Conditions
- Carcinoma, Hepatocellular, Neoplasms, Glandular and Epithelial, Adenocarcinoma, Digestive System Neoplasms, Liver Neoplasms
- Keywords
- Multimodal, Tislelizumab, lenvatinib, TACE, unresectable primary liver cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 31 Jan 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Jan 2025 (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.
This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.
Detailed description
This study aims to evaluate the efficacy and safety of multimodal ablation combined with Tislelizumab, lenvatinib, and TACE in the treatment of primary liver cancer. By comparing preoperative and postoperative immune markers, the study seeks to clarify the clinical value of multimodal ablation combined with systemic therapy and TACE in the management of primary liver cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Multimodal Thermal TherapyThe patient will receive induction therapy with tislelizumab and lenvatinib within 14 days after enrollment. Subsequently, within 2-7 days (the exact timing will be determined based on clinical circumstances), they will undergo Multimodal Thermal Therapy (MTT). Following the MTT procedure, on-demand TACE treatment will be administered. Starting from day 7 post-MTT (with the exact timing adjusted according to clinical conditions), the patient will resume tislelizumab and lenvatinib therapy until disease progression, occurrence of intolerable toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-80 years, regardless of gender.
- Clinically or pathologically confirmed HCC.
- CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.
- Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor >5 cm.
- Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment..
Key exclusion criteria (14 listed)
- Child-Pugh class C liver dysfunction.
- Tumor thrombus in the main portal vein or hepatic vein.
- Extensive metastatic disease with an expected survival <3 months.
- Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).
- History of esophageal/gastric variceal bleeding within the past month.
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 |
|---|---|---|
| Multimodal Thermal TherapyThe high-burden tumor is identified as the target lesion for treatment. A pre-treatment biopsy of the target lesion is performed to obtain tumor tissue. Multimodal ablation therapy of the target lesion is conducted under CT guidance. The treatment procedure follows the tumor ablation protocol using the multimodal therapy radiofrequency temperature-controlled mode. | Device | Treatment Group |
Primary outcome
Objective response rate (ORR) according to RECIST 1.1 and mRECIST
Time frame: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.
Refers to the proportion of patients whose tumors shrink to a certain extent and maintain that response for a specified period, including cases of Complete Response (CR) and Partial Response (PR). Tumor objective response is assessed using RECIST 1.1 and mRECIST criteria. At baseline, subjects must have measurable tumor lesions. According to the efficacy evaluation criteria, the outcomes are classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD).
3 secondary outcomes
Progression-Free Survival（PFS）
Time frame: Follow-up for 12 months,with assessments conducted every 3 months.
Overall Survival（OS）
Time frame: Follow-up for 12 months,with assessments conducted every 3 months.
Safety and Tolerability
Time frame: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.
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 11 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Thermal Therapy in people with Carcinoma, Hepatocellular and Neoplasms, Glandular and Epithelial, run by Shanghai Zhongshan Hospital 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 7 inclusion and 14 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 11 May 2026. 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 zhiping Yan, M.D (+86 13122806500, yan.zhiping@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) according to RECIST 1.1 and mRECIST (time frame: Follow-up for 12 months, with evaluations conducted at 2 weeks, 6 weeks, 3 months, 6 months, 9 months, and 12 months postoperatively.). 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 11 May 2026.