Hepatocellular CarcinomaNCT06519721
Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC
A study testing Lenvatinib Combined with VIC-1911 in people with Hepatocellular Carcinoma, run by RenJi Hospital at 1 site in China.
Trial summary
This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Lenvatinib Combined with VIC-1911
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2024to 31 Jul 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
- Gender unrestricted, age 18-75 years;
- HCC conforms to AASLD or EASL clinical diagnostic standards;
- HCC Barcelona Clinic Liver Cancer (BCLC) staging is C, with at least one measurable tumor in the liver (longest diameter ≥1cm);
- Liver function Child-Pugh Class A or Class B with a score of 7;
- ECOG score of 0-1;
- Platelet count ≥60×10^9/L, PT time prolongation ≤6 seconds.
Who cannot join
- Irreversible coagulation dysfunction, with obvious bleeding tendency;
- Patients who need long-term anticoagulation or antiplatelet treatment and cannot stop medication;
- Patients with unstable or active ulcers, gastrointestinal bleeding;
- Patients with untreated heart disease or poorly controlled hypertension as judged by the researcher;
- Severe dysfunction of important organs, such as severe cardiopulmonary dysfunction;
- Patients with hepatic encephalopathy or refractory ascites requiring treatment;
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- Human Immunodeficiency Virus (HIV) infection;
- Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (activity defined as viral load > 20000 IU/mL), or HBV, HCV positive patients who refuse to accept standardized antiviral treatment;
- Inability to swallow oral medication.
- Gastrointestinal diseases that may affect the absorption or tolerance of the study medication.
- History of corneal epithelial cysts or other causes of blurred vision, or medical abnormalities found in ophthalmic screening.
- Known allergy to VIC-1911 or its components.
- Within 4 weeks before the study, radiotherapy or interventional therapy for the disease under study was performed;
- Other concurrent antitumor treatments;
- The researcher assesses that the patient cannot or is unwilling to comply with the requirements of the study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, 200127
About this study
Official title: Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced Hepatocellular Carcinoma
This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.
Read the detailed description
This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.
Purpose of the Study:
To observe and determine the safety and efficacy of lenvatinib combined with VIC-1911 in the treatment of patients with advanced liver cancer.
Sample Size:
According to the research plan, the administration of the study medication is divided into two stages, with 3 patients enrolled in the accelerated titration phase and 12 patients in the expansion phase.
Study Subjects:
Patients with advanced HCC
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Lenvatinib Combined with VIC-1911
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib Combined with VIC-1911Drug
Oral administration:
Lenvatinib:
Take the clinically normal dose: ≤60Kg body weight, 8mg/day; >60Kg body weight, 12mg/day;
VIC-1911:
Phase 1: Accelerated titration phase Plan to enroll 3 patients. First, enroll 1 patient, give the initial dose of VIC-1911 25mg BID, observe for 1 week, if there is no dose-limiting toxicity (DLT), increase to 50mg BID. At the same time, enroll another 2 patients, give VIC-1911 25mg BID, observe for 1 week, if no DLT, increase to 50mg BID. Observe for 2 weeks at a dose of 50mg, if no DLT occurs, continue to increase to 75mg BID, observe for 4 weeks. If no DLT occurs, continue to increase by 25mg doses, with an observation period of 4 weeks, until one case of dose-limiting toxicity or two cases of moderate toxicity occur during the titration process, then reduce to the previous dose, and determine it as the final dosing regimen.
Phase 2: Expansion phase According to the final dosing regimen selected, enroll 12 patients and observe for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Accelerated titration phase | Experimental | Plan to enroll 3 patients. First, enroll 1 patient, give the initial dose of VIC-1911 25mg BID, observe for 1 week, if there is no dose-limiting toxicity (DLT), increase to 50mg BID. At the same time, enroll another 2 patients, give VIC-1911 25mg BID, observe for 1 week, if no DLT, increase to 50mg BID. Observe for 2 weeks at a dose of 50mg, if no DLT occurs, continue to increase to 75mg BID, observe for 4 weeks. If no DLT occurs, continue to increase by 25mg doses, with an observation period of 4 weeks, until one case of dose-limiting toxicity or two cases of moderate toxicity occur during the titration process, then reduce to the previous dose, and determine it as the final dosing regimen. Receives: Drug: Lenvatinib Combined with VIC-1911 |
| Phase 2: Expansion phase | Experimental | According to the final dosing regimen selected, enroll 12 patients and observe for 3 months. Receives: Drug: Lenvatinib Combined with VIC-1911 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of patients experiencing a complete or partial response to a treatment
Measured: 2 years
Secondary outcomes (2)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the length of time during a study that a patient with a known cancer diagnosis does not experience disease worsening or death due to the disease.
Measured: 2 years
Overall Survival (OS)
Overall Survival (OS) is defined as the percentage of patients in a study or a group of patients who are alive for a certain period of time after the start of treatment.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start6 Aug 2024
- Primary completion24 Dec 2025
- Study completion31 Jul 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 RenJi 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519721
- Sponsor's protocol ID
- RJ-LY2022-024-B
- Status last verified
- Apr 2026
- First submitted
- 21 Jul 2024
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06519721
- Acronym / sponsor ID
- RJ-LY2022-024-B
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 25 Jul 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.
This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.
Detailed description
This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.
Purpose of the Study:
To observe and determine the safety and efficacy of lenvatinib combined with VIC-1911 in the treatment of patients with advanced liver cancer.
Sample Size:
According to the research plan, the administration of the study medication is divided into two stages, with 3 patients enrolled in the accelerated titration phase and 12 patients in the expansion phase.
Study Subjects:
Patients with advanced HCC
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Accelerated titration phase | Experimental | Drug: Lenvatinib Combined with VIC-1911Plan to enroll 3 patients. First, enroll 1 patient, give the initial dose of VIC-1911 25mg BID, observe for 1 week, if there is no dose-limiting toxicity (DLT), increase to 50mg BID. At the same time, enroll another 2 patients, give VIC-1911 25mg BID, observe for 1 week, if no DLT, increase to 50mg BID. Observe for 2 weeks at a dose of 50mg, if no DLT occurs, continue to increase to 75mg BID, observe for 4 weeks. If no DLT occurs, continue to increase by 25mg doses, with an observation period of 4 weeks, until one case of dose-limiting toxicity or two cases of moderate toxicity occur during the titration process, then reduce to the previous dose, and determine it as the final dosing regimen. |
| Phase 2: Expansion phase | Experimental | Drug: Lenvatinib Combined with VIC-1911According to the final dosing regimen selected, enroll 12 patients and observe for 3 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Gender unrestricted, age 18-75 years;
- HCC conforms to AASLD or EASL clinical diagnostic standards;
- HCC Barcelona Clinic Liver Cancer (BCLC) staging is C, with at least one measurable tumor in the liver (longest diameter ≥1cm);
- Liver function Child-Pugh Class A or Class B with a score of 7;
- ECOG score of 0-1;
Key exclusion criteria (15 listed)
- Irreversible coagulation dysfunction, with obvious bleeding tendency;
- Patients who need long-term anticoagulation or antiplatelet treatment and cannot stop medication;
- Patients with unstable or active ulcers, gastrointestinal bleeding;
- Patients with untreated heart disease or poorly controlled hypertension as judged by the researcher;
- Severe dysfunction of important organs, such as severe cardiopulmonary dysfunction;
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 Combined with VIC-1911Oral administration: Lenvatinib: Take the clinically normal dose: ≤60Kg body weight, 8mg/day; >60Kg body weight, 12mg/day; VIC-1911: Phase 1: Accelerated titration phase Plan to enroll 3 patients. First, enroll 1 patient, give the initial dose of VIC-1911 25mg BID, observe for 1 week, if there is no dose-limiting toxicity (DLT), increase to 50mg BID. At the same time, enroll another 2 patients, give VIC-1911 25mg BID, observe for 1 week, if no DLT, increase to 50mg BID. Observe for 2 weeks at a dose of 50mg, if no DLT occurs, continue to increase to 75mg BID, observe for 4 weeks. If no DLT occurs, continue to increase by 25mg doses, with an observation period of 4 weeks, until one case of dose-limiting toxicity or two cases of moderate toxicity occur during the titration process, then reduce to the previous dose, and determine it as the final dosing regimen. Phase 2: Expansion phase According to the final dosing regimen selected, enroll 12 patients and observe for 3 months. | Drug | Phase 1: Accelerated titration phase, Phase 2: Expansion phase |
Primary outcome
Objective Response Rate (ORR)
Time frame: 2 years
Objective Response Rate (ORR) is defined as the proportion of patients experiencing a complete or partial response to a treatment
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
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 30 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lenvatinib Combined with VIC-1911 in people with Hepatocellular Carcinoma, run by RenJi 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 6 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 30 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 2 years). 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 30 Apr 2026.