HCC - Hepatocellular CarcinomaPhase 2NCT07157969
ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC
A Phase 2 study testing Lenvatinib, Pembrolizumab and Atezolizumab in people with HCC - Hepatocellular Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma
- What is being tested?
- Lenvatinib, Pembrolizumab and Atezolizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2025to 30 Jun 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up.
- Age ≥18 years at the time of signing informed consent, regardless of gender.
- Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology.
- BCLC Stage B or C.
- At least one measurable lesion per RECIST 1.1.
- ECOG score of 0-1.
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- Child-Pugh liver function class A or B.
- Life expectancy ≥ 3 months.
- Adequate hematological and organ function.
Who cannot join
- Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver transplantation.
- Pregnant or breastfeeding women.
- Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
- Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic artery embolism, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection.
- History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
- Presence of unhealed severe wounds, active ulcers, or untreated fractures.
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- Active autoimmune disease or history of autoimmune disorders.
- Significant history of gastrointestinal diseases.
- Significant history of cardiovascular or cerebrovascular diseases.
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
Peking Union Medical College Hospital
Beijing
Haitao Zhao, +86-10-69152830, zhaoht@pumch.cn
About this study
Official title: Immune Checkpoint Inhibitors and Anti-Vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without Interventional Therapy for Advanced HCC
This trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.
- Conditions
- HCC - Hepatocellular Carcinoma
- Being tested
- Lenvatinib, Pembrolizumab, Atezolizumab, Bevacizumab, 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.
LenvatinibDrug
≥60 kg: 12 mg once daily, or <60 kg: 8 mg once daily
PembrolizumabDrug
200 mg intravenously every three weeks
AtezolizumabDrug
1200 mg intravenously every three weeks
BevacizumabDrug
15mg/kg intravenously every three weeks
CamrelizumabDrug
200 mg intravenously every three weeks
ApatinibDrug
250mg once daily
TACEProcedure or surgery
The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
HAICProcedure or surgery
The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
DEB-TACEProcedure or surgery
The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
TislelizumabDrug
200 mg intravenously every three weeks
SintilimabDrug
200 mg intravenously every three weeks
| Study group | Role | What they receive |
|---|---|---|
| Immune checkpoint inhibitors combined with anti-VEGF drugs | Active comparator | Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Receives: Drug: Lenvatinib; Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Bevacizumab; Drug: Camrelizumab; Drug: Apatinib; Drug: Tislelizumab; Drug: Sintilimab |
| Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy | Experimental | Immune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab.
Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC. Receives: Drug: Lenvatinib; Drug: Pembrolizumab; Drug: Atezolizumab; Drug: Bevacizumab; Drug: Camrelizumab; Drug: Apatinib; Procedure: TACE; Procedure: HAIC; Procedure: DEB-TACE; Drug: Tislelizumab; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR, objective response rate
Measured: 12 months after the last subject is enrolled
Secondary outcomes (6)
PFS, progression free survival
Measured: 12 months after the last subject is enrolled
OS, overall survival
Measured: 12 months after the last subject is enrolled
DCR, disease control rate
Measured: 12 months after the last subject is enrolled
DoR, duration of response
Measured: 12 months after the last subject is enrolled
Adverse events (AE)
Measured: 12 months after the last subject is enrolled
Serious adverse events (SAE)
Measured: 12 months after the last subject is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start19 Feb 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157969
- Sponsor's protocol ID
- K7470
- Status last verified
- Feb 2025
- First submitted
- 28 Aug 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim JH, Zhao H, Li C, Madoff DC, Ghobrial RM, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry AB, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS, Llovet JM; LEAP-012 investigators. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2025 Jan 18;405(10474):203-215. doi: 10.1016/S0140-6736(24)02575-3. Epub 2025 Jan 8.
PubMed 39798578
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Checkpoint Inhibitors and Anti-Vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without Interventional Therapy for Advanced HCC
- ClinicalTrials.gov ID
- NCT07157969
- Acronym / sponsor ID
- K7470
- Conditions
- HCC - Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 5 Sep 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 trial is designed to explore the efficacy and safety of interventional therapy combined with immune checkpoint inhibitors(ICIs) and anti-vascular endothelial growth factor(VEGF) antibody/tyrosine kinase inhibitors in the treatment of advanced hepatocellular carcinoma. Eligible participants will be divided into two groups based on their treatment plans: one receiving ICIs combined with anti-VEGF drugs, and the other receiving ICIs combined with anti-VEGF drugs alongside interventional therapy, which includes C-TACE, D-TACE, and HAIC. The specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition.
Researchers will closely monitor and rigorously evaluate the efficacy and safety of the treatment in participants through follow-up assessments. The primary endpoint is the objective response rate , while secondary endpoints include disease control rate, progression-free survival, overall survival, duration of response, adverse events, and serious adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immune checkpoint inhibitors combined with anti-VEGF drugs | Active comparator | Drug: Lenvatinib, Drug: Pembrolizumab, Drug: Atezolizumab, Drug: Bevacizumab, Drug: Camrelizumab, Drug: Apatinib, Drug: Tislelizumab, Drug: SintilimabImmune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab. Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. |
| Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy | Experimental | Drug: Lenvatinib, Drug: Pembrolizumab, Drug: Atezolizumab, Drug: Bevacizumab, Drug: Camrelizumab, Drug: Apatinib, Procedure: TACE, Procedure: HAIC, Procedure: DEB-TACE, Drug: Tislelizumab, Drug: SintilimabImmune checkpoint inhibitors include Pembrolizumab, Atezolizumab, Camrelizumab, Tislelizumab, and Sintilimab. Anti-VEGF drugs include Bevacizumab, Lenvatinib, and Apatinib. Interventional therapy includes C-TACE, D-TACE, and HAIC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and are cooperative with follow-up.
- Age ≥18 years at the time of signing informed consent, regardless of gender.
- Diagnosis of hepatocellular carcinoma confirmed by imaging (according to AASLD criteria), histology, or cytology.
- BCLC Stage B or C.
- At least one measurable lesion per RECIST 1.1.
Key exclusion criteria (9 listed)
- Patients with hepatocellular carcinoma who are candidates for surgical radical cure, or have undergone radical surgery without evaluable lesions, or have a history of or are planned for liver transplantation.
- Pregnant or breastfeeding women.
- Individuals with known allergy or intolerance to recombinant humanized PD-1/PD-L1 monoclonal antibody preparations.
- Received local-regional therapy within 4 weeks before the first dose of the study drug, including but not limited to surgery, radiotherapy, hepatic artery embolism, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection.
- History of other malignant tumors within 5 years prior to screening, except for hepatocellular carcinoma.
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 |
|---|---|---|
| Lenvatinib≥60 kg: 12 mg once daily, or <60 kg: 8 mg once daily | Drug | Immune checkpoint inhibitors combined with anti-VEGF drugs, Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
| Pembrolizumab200 mg intravenously every three weeks | Drug | Immune checkpoint inhibitors combined with anti-VEGF drugs, Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
| Atezolizumab1200 mg intravenously every three weeks | Drug | Immune checkpoint inhibitors combined with anti-VEGF drugs, Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
| Bevacizumab15mg/kg intravenously every three weeks | Drug | Immune checkpoint inhibitors combined with anti-VEGF drugs, Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
| Camrelizumab200 mg intravenously every three weeks | Drug | Immune checkpoint inhibitors combined with anti-VEGF drugs, Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
| Apatinib250mg once daily | Drug | Immune checkpoint inhibitors combined with anti-VEGF drugs, Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
| TACEThe specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. | Procedure or surgery | Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
| HAICThe specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. | Procedure or surgery | Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
| DEB-TACEThe specific number and interval of interventional therapy sessions will be determined according to the patient's individual condition. | Procedure or surgery | Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
| Tislelizumab200 mg intravenously every three weeks | Drug | Immune checkpoint inhibitors combined with anti-VEGF drugs, Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
| Sintilimab200 mg intravenously every three weeks | Drug | Immune checkpoint inhibitors combined with anti-VEGF drugs, Immune checkpoint inhibitors combined with anti-VEGF drugs alongside interventional therapy |
Primary outcome
ORR, objective response rate
Time frame: 12 months after the last subject is enrolled
6 secondary outcomes
PFS, progression free survival
Time frame: 12 months after the last subject is enrolled
OS, overall survival
Time frame: 12 months after the last subject is enrolled
DCR, disease control rate
Time frame: 12 months after the last subject is enrolled
DoR, duration of response
Time frame: 12 months after the last subject is enrolled
Adverse events (AE)
Time frame: 12 months after the last subject is enrolled
Serious adverse events (SAE)
Time frame: 12 months after the last subject is enrolled
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 1 Dec 2025.
- Background: PubMed 39798578Kudo M, Ren Z, Guo Y, Han G, Lin H, Zheng J, Ogasawara S, Kim JH, Zhao H, Li C, Madoff DC, Ghobrial RM, Kawaoka T, Gerolami R, Ikeda M, Kumada H, El-Khoueiry AB, Vogel A, Peng X, Mody K, Dutcus C, Dubrovsky L, Siegel AB, Finn RS, Llovet JM; LEAP-012 investigators. Transarterial chemoembolisation combined with lenvatinib plus pembrolizumab versus dual placebo for unresectable, non-metastatic hepatocellular carcinoma (LEAP-012): a multicentre, randomised, double-blind, phase 3 study. Lancet. 2025 Jan 18;405(10474):203-215. doi: 10.1016/S0140-6736(24)02575-3. Epub 2025 Jan 8.
- 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 Phase 2 study testing Lenvatinib, Pembrolizumab and Atezolizumab in people with HCC - Hepatocellular Carcinoma, run by Peking Union Medical College 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 9 inclusion and 9 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 1 Dec 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Shi Feng (86-18601989848, fengshi0762@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR, objective response rate (time frame: 12 months after the last subject is enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07157969, which also lists 1 linked publication.
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 1 Dec 2025.