Hepatocellular Carcinoma (HCC)Phase 3NCT07537946
Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer
A Phase 3 study testing Sintilimab, Lenvatinib and Comprehensive Local Consolidative Therapy in people with Hepatocellular Carcinoma (HCC) and Metastases, run by Tongji Hospital at 1 site in China.
Trial summary
This study evaluates whether comprehensive local consolidative therapy added to continued sintilimab plus lenvatinib improves survival compared with continued sintilimab plus lenvatinib alone in patients with oligo-extrahepatic metastatic hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Metastases
- What is being tested?
- Sintilimab, Lenvatinib and Comprehensive Local Consolidative Therapy
- 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
- 400 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2026to 30 Jul 2031
- Phase
- Phase 3
- 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
- Age 18 to 75 years
- Hepatocellular carcinoma confirmed by imaging and/or histology according to institutional diagnostic standards
- Advanced or unresectable disease with extrahepatic metastases meeting protocol-defined oligo-extrahepatic metastatic disease criteria: 1 to 5 extrahepatic metastatic lesions and no more than 2 involved extrahepatic organs
- At least 1 measurable lesion according to RECIST version 1.1
- No prior systemic therapy for advanced or metastatic hepatocellular carcinoma
- ECOG performance status 0 to 1
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- Child-Pugh class A or stable Child-Pugh B7
- Adequate hematologic, hepatic, renal, and coagulation function according to protocol
- Baseline center multidisciplinary team assessment indicating potential feasibility for complete consolidative intent if disease control is achieved after induction
- Written informed consent and willingness to comply with treatment, follow-up, and protocol-required assessments
Who cannot join
- More than 5 extrahepatic metastatic lesions or more than 2 involved extrahepatic organs
- Diffuse peritoneal seeding, leptomeningeal disease, or uncontrolled brain metastases
- Main portal vein trunk invasion, extensive inferior vena cava or right atrial tumor thrombus, or disease considered unlikely to become fully consolidable after induction
- Diffuse intrahepatic disease or liver tumor burden considered unlikely to be controllable with protocol-specified local treatment
- Prior PD-1, PD-L1, CTLA-4, anti-VEGF monoclonal antibody, tyrosine kinase inhibitor, or other systemic antitumor therapy for advanced HCC
- Active autoimmune disease requiring systemic immunosuppression
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- Active severe infection, including uncontrolled bacterial or fungal infection, active tuberculosis, or uncontrolled hepatitis B without appropriate antiviral therapy
- Gastrointestinal bleeding within the previous 6 months, or untreated or uncontrolled high-risk gastroesophageal varices
- Uncontrolled hypertension, recent major thrombotic event, myocardial infarction, unstable angina, or stroke
- Active interstitial lung disease or noninfectious pneumonitis requiring systemic treatment
- Severe proteinuria or renal dysfunction considered unsuitable for lenvatinib treatment
- Pregnancy or breastfeeding
- Any condition that, in the investigator's judgment, would make participation unsafe or compromise protocol compliance
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
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: Comprehensive Local Consolidative Therapy Versus Continued Sintilimab Plus Lenvatinib Alone After Induction Sintilimab Plus Lenvatinib in Patients With Oligo-Extrahepatic Metastatic Hepatocellular Carcinoma: A Multicenter Prospective Randomized Trial
This study evaluates whether comprehensive local consolidative therapy added to continued sintilimab plus lenvatinib improves survival compared with continued sintilimab plus lenvatinib alone in patients with oligo-extrahepatic metastatic hepatocellular carcinoma. All enrolled participants receive induction treatment with sintilimab plus lenvatinib for 4 cycles. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for complete consolidation are randomized in a 1:1 ratio to receive either comprehensive local consolidative therapy followed by continued systemic therapy or continued systemic therapy alone. The primary outcome is overall survival.
Read the detailed description
This is a multicenter, prospective, open-label, randomized, event-driven phase 3 strategy trial in patients with oligo-extrahepatic metastatic hepatocellular carcinoma (HCC). All enrolled participants receive induction therapy with sintilimab 200 mg intravenously every 3 weeks plus lenvatinib orally once daily for 4 cycles. The recommended lenvatinib dose is 12 mg once daily for participants with body weight greater than or equal to 60 kg and 8 mg once daily for participants with body weight less than 60 kg. Approximately 620 participants are expected to enter induction, and approximately 400 participants are expected to undergo 1:1 randomization after induction.
After 4 induction cycles, participants undergo imaging reassessment and central multidisciplinary team review. Only participants with disease control by blinded independent central review and central confirmation that all residual active lesions can be safely covered by comprehensive local consolidative therapy are eligible for randomization. Randomized participants are assigned to either comprehensive local consolidative therapy plus continued sintilimab and lenvatinib or continued sintilimab and lenvatinib alone.
Comprehensive local consolidative therapy is intended to treat all residual active lesions, including intrahepatic and extrahepatic disease, using protocol-specified stereotactic body radiotherapy, thermal ablation, surgery, or a combination thereof. Consolidative treatment should begin within 4 to 8 weeks after randomization. In the control arm, planned full-lesion consolidative local treatment is not permitted before RECIST-defined progression, although urgent palliative local treatment may be allowed when medically necessary and will be recorded.
The primary endpoint is overall survival from randomization. Key secondary endpoints include progression-free survival, time to strategy failure, time to widespread progression, no-evidence-of-disease rate at 12 weeks after randomization, local control rate, time to next-line systemic therapy, quality of life, and safety. Imaging is performed during induction at Week 6 and Week 12, then every 6 weeks through Week 54 after randomization and every 9 weeks thereafter until progression, treatment discontinuation, death, or study end. Safety monitoring includes treatment-related adverse events, immune-related adverse events, anti-VEGF-related adverse events, and local treatment-related complications.
- Conditions
- Hepatocellular Carcinoma (HCC), Metastases
- Being tested
- Sintilimab, Lenvatinib, Comprehensive Local Consolidative Therapy
- Keywords
- Oligometastatic, Hepatocellular Carcinoma, Sintilimab, Lenvatinib, Comprehensive Local Consolidative Therapy, Surgery, Ablation
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabDrug
Sintilimab 200 mg administered as an intravenous infusion every 3 weeks during induction and continued after randomization until disease progression, unacceptable toxicity, withdrawal of consent, investigator decision, or a maximum duration of 24 months, according to protocol.
LenvatinibDrug
Lenvatinib administered orally once daily during induction and continued after randomization until disease progression or unacceptable toxicity. The recommended dose is 12 mg once daily for participants with body weight greater than or equal to 60 kg and 8 mg once daily for participants with body weight less than 60 kg. Dose interruption, reduction, and discontinuation are managed according to protocol and product labeling.
Comprehensive Local Consolidative TherapyProcedure or surgery
Protocol-specified comprehensive local consolidative therapy directed at all residual active lesions after induction treatment, including stereotactic body radiotherapy, thermal ablation, surgery, or a combination thereof, performed within 4 to 8 weeks after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Induction Sintilimab Plus Lenvatinib Followed by Comprehensive Local Consolidative Therapy and Conti | Experimental | All enrolled participants receive induction sintilimab plus lenvatinib. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for full-lesion consolidation are randomized to receive comprehensive local consolidative therapy to all residual active lesions within 4 to 8 weeks after randomization, followed by continued sintilimab plus lenvatinib. Receives: Drug: Sintilimab; Drug: Lenvatinib; Procedure: Comprehensive Local Consolidative Therapy |
| Induction Sintilimab Plus Lenvatinib Followed by Continued Systemic Therapy Alone | Active comparator | All enrolled participants receive induction sintilimab plus lenvatinib. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for full-lesion consolidation are randomized to continue sintilimab plus lenvatinib alone without protocol-planned comprehensive local consolidative therapy before RECIST-defined progression. Receives: Drug: Sintilimab; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival is defined as the time from randomization to death from any cause.
Measured: From randomization until death from any cause, assessed up to 60 months
Secondary outcomes (2)
Time to Strategy Failure
Time to strategy failure is defined as the time from randomization to progression, inability to continue the assigned treatment strategy, initiation of non-protocol antitumor therapy, or death.
Measured: From randomization through 60 months
Time to Widespread Progression
Time to widespread progression is defined as the time from randomization to protocol-defined widespread disease progression or death.
Measured: From randomization through 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start30 May 2026 (estimated)
- Primary completion30 May 2031 (estimated)
- Study completion30 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Tongji 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All enrolled participants receive induction sintilimab plus lenvatinib. Participants with disease control and central multidisciplinary team-confirmed complete consolidative feasibility after induction are randomized in a 1:1 ratio to either comprehensive local consolidative therapy plus continued sintilimab and lenvatinib or continued sintilimab and lenvatinib alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaoping, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537946
- Sponsor's protocol ID
- EXACT-EMH-HCC-011
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Local Consolidative Therapy Versus Continued Sintilimab Plus Lenvatinib Alone After Induction Sintilimab Plus Lenvatinib in Patients With Oligo-Extrahepatic Metastatic Hepatocellular Carcinoma: A Multicenter Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT07537946
- Acronym / sponsor ID
- EXACT-EMH-HCC-011
- Conditions
- Hepatocellular Carcinoma (HCC), Metastases
- Keywords
- Oligometastatic, Hepatocellular Carcinoma, Sintilimab, Lenvatinib, Comprehensive Local Consolidative Therapy, Surgery, Ablation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 30 May 2026 (estimated)
- Primary completion
- 30 May 2031 (estimated)
- Study completion
- 30 Jul 2031 (estimated)
- First posted
- 17 Apr 2026 (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 evaluates whether comprehensive local consolidative therapy added to continued sintilimab plus lenvatinib improves survival compared with continued sintilimab plus lenvatinib alone in patients with oligo-extrahepatic metastatic hepatocellular carcinoma. All enrolled participants receive induction treatment with sintilimab plus lenvatinib for 4 cycles. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for complete consolidation are randomized in a 1:1 ratio to receive either comprehensive local consolidative therapy followed by continued systemic therapy or continued systemic therapy alone. The primary outcome is overall survival.
Detailed description
This is a multicenter, prospective, open-label, randomized, event-driven phase 3 strategy trial in patients with oligo-extrahepatic metastatic hepatocellular carcinoma (HCC). All enrolled participants receive induction therapy with sintilimab 200 mg intravenously every 3 weeks plus lenvatinib orally once daily for 4 cycles. The recommended lenvatinib dose is 12 mg once daily for participants with body weight greater than or equal to 60 kg and 8 mg once daily for participants with body weight less than 60 kg. Approximately 620 participants are expected to enter induction, and approximately 400 participants are expected to undergo 1:1 randomization after induction.
After 4 induction cycles, participants undergo imaging reassessment and central multidisciplinary team review. Only participants with disease control by blinded independent central review and central confirmation that all residual active lesions can be safely covered by comprehensive local consolidative therapy are eligible for randomization. Randomized participants are assigned to either comprehensive local consolidative therapy plus continued sintilimab and lenvatinib or continued sintilimab and lenvatinib alone.
Comprehensive local consolidative therapy is intended to treat all residual active lesions, including intrahepatic and extrahepatic disease, using protocol-specified stereotactic body radiotherapy, thermal ablation, surgery, or a combination thereof. Consolidative treatment should begin within 4 to 8 weeks after randomization. In the control arm, planned full-lesion consolidative local treatment is not permitted before RECIST-defined progression, although urgent palliative local treatment may be allowed when medically necessary and will be recorded.
The primary endpoint is overall survival from randomization. Key secondary endpoints include progression-free survival, time to strategy failure, time to widespread progression, no-evidence-of-disease rate at 12 weeks after randomization, local control rate, time to next-line systemic therapy, quality of life, and safety. Imaging is performed during induction at Week 6 and Week 12, then every 6 weeks through Week 54 after randomization and every 9 weeks thereafter until progression, treatment discontinuation, death, or study end. Safety monitoring includes treatment-related adverse events, immune-related adverse events, anti-VEGF-related adverse events, and local treatment-related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All enrolled participants receive induction sintilimab plus lenvatinib. Participants with disease control and central multidisciplinary team-confirmed complete consolidative feasibility after induction are randomized in a 1:1 ratio to either comprehensive local consolidative therapy plus continued sintilimab and lenvatinib or continued sintilimab and lenvatinib alone.
| Arm | Type | Receives |
|---|---|---|
| Induction Sintilimab Plus Lenvatinib Followed by Comprehensive Local Consolidative Therapy and Conti | Experimental | Drug: Sintilimab, Drug: Lenvatinib, Procedure: Comprehensive Local Consolidative TherapyAll enrolled participants receive induction sintilimab plus lenvatinib. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for full-lesion consolidation are randomized to receive comprehensive local consolidative therapy to all residual active lesions within 4 to 8 weeks after randomization, followed by continued sintilimab plus lenvatinib. |
| Induction Sintilimab Plus Lenvatinib Followed by Continued Systemic Therapy Alone | Active comparator | Drug: Sintilimab, Drug: LenvatinibAll enrolled participants receive induction sintilimab plus lenvatinib. Participants who achieve disease control and are confirmed by central multidisciplinary review to be feasible for full-lesion consolidation are randomized to continue sintilimab plus lenvatinib alone without protocol-planned comprehensive local consolidative therapy before RECIST-defined progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 to 75 years
- Hepatocellular carcinoma confirmed by imaging and/or histology according to institutional diagnostic standards
- Advanced or unresectable disease with extrahepatic metastases meeting protocol-defined oligo-extrahepatic metastatic disease criteria: 1 to 5 extrahepatic metastatic lesions and no more than 2 involved extrahepatic organs
- At least 1 measurable lesion according to RECIST version 1.1
- No prior systemic therapy for advanced or metastatic hepatocellular carcinoma
Key exclusion criteria (13 listed)
- More than 5 extrahepatic metastatic lesions or more than 2 involved extrahepatic organs
- Diffuse peritoneal seeding, leptomeningeal disease, or uncontrolled brain metastases
- Main portal vein trunk invasion, extensive inferior vena cava or right atrial tumor thrombus, or disease considered unlikely to become fully consolidable after induction
- Diffuse intrahepatic disease or liver tumor burden considered unlikely to be controllable with protocol-specified local treatment
- Prior PD-1, PD-L1, CTLA-4, anti-VEGF monoclonal antibody, tyrosine kinase inhibitor, or other systemic antitumor therapy for advanced HCC
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 |
|---|---|---|
| SintilimabSintilimab 200 mg administered as an intravenous infusion every 3 weeks during induction and continued after randomization until disease progression, unacceptable toxicity, withdrawal of consent, investigator decision, or a maximum duration of 24 months, according to protocol. | Drug | Induction Sintilimab Plus Lenvatinib Followed by Comprehensive Local Consolidative Therapy and Conti, Induction Sintilimab Plus Lenvatinib Followed by Continued Systemic Therapy Alone |
| LenvatinibLenvatinib administered orally once daily during induction and continued after randomization until disease progression or unacceptable toxicity. The recommended dose is 12 mg once daily for participants with body weight greater than or equal to 60 kg and 8 mg once daily for participants with body weight less than 60 kg. Dose interruption, reduction, and discontinuation are managed according to protocol and product labeling. | Drug | Induction Sintilimab Plus Lenvatinib Followed by Comprehensive Local Consolidative Therapy and Conti, Induction Sintilimab Plus Lenvatinib Followed by Continued Systemic Therapy Alone |
| Comprehensive Local Consolidative TherapyProtocol-specified comprehensive local consolidative therapy directed at all residual active lesions after induction treatment, including stereotactic body radiotherapy, thermal ablation, surgery, or a combination thereof, performed within 4 to 8 weeks after randomization. | Procedure or surgery | Induction Sintilimab Plus Lenvatinib Followed by Comprehensive Local Consolidative Therapy and Conti |
Primary outcome
Overall Survival
Time frame: From randomization until death from any cause, assessed up to 60 months
Overall survival is defined as the time from randomization to death from any cause.
2 secondary outcomes
Time to Strategy Failure
Time frame: From randomization through 60 months
Time to Widespread Progression
Time frame: From randomization through 60 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 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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 Phase 3 study testing Sintilimab, Lenvatinib and Comprehensive Local Consolidative Therapy in people with Hepatocellular Carcinoma (HCC) and Metastases, run by Tongji 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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 17 Apr 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhao Huang, M.D (+86 13006378908, huangzhao@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From randomization until death from any cause, assessed up to 60 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 17 Apr 2026.