Hepatocellular Carcinoma (HCC)Phase 2NCT07150377
A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Lenvatinib and TACE for Advanced Hepatocellular Carcinoma
A Phase 2 study testing First-line Cohort and Second-line Cohort in people with Hepatocellular Carcinoma (HCC), run by The Second Affiliated Hospital of Shandong First Medical University.
Trial summary
To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- First-line Cohort and Second-line Cohort
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 24 Aug 2025to 24 Aug 2028
- 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
- First-line Cohort:
- Confirmed diagnosis of hepatocellular carcinoma (HCC), aged > 18 years. No prior systemic therapy.
- Child-Pugh class A/B at baseline.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- Adequate organ and bone marrow function.
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- Second-line Cohort:
- Confirmed diagnosis of HCC, aged > 18 years.
- Prior first-line therapy (including targeted therapy or immunotherapy).
- Child-Pugh class A/B at baseline.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
- Measurable lesions per modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- Adequate organ and bone marrow function.
Who cannot join
- Concomitant hepatic encephalopathy.
- History of any nephrotic syndrome.
- History of clinically significant cardiovascular disease or arterial thromboembolic events, including stroke, myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization.
- Evidence of any prior or current coagulopathy or bleeding diathesis, or any type of surgery performed within the past 28 days (biopsy is not excluded).
- History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization.
- Main portal vein thrombosis visible on baseline imaging.
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- Pleural or peritoneal effusion requiring clinical intervention.
- Gastroesophageal varices.
- Portal vein invasion (VP3 or VP4).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- First-line Cohort, Second-line Cohort
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First-line CohortDrug
Iparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd
Second-line CohortDrug
Iparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular car | Experimental | Not described Receives: Drug: First-line Cohort; Drug: Second-line Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Measured: 1 year
Secondary outcomes (3)
OS
Time from randomization to death from any cause
Measured: 2 years
Objective Response Rate
It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR)
Measured: 1 year
Adverse Events
It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug It refers to all adverse medical events that occur after a subject receives an investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily be causally related to the investigational drug
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 posted2 Sep 2025
- Study start24 Aug 2025 (estimated)
- Primary completion24 Aug 2026 (estimated)
- Study completion24 Aug 2028 (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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Shandong First Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yan hai Liu, Principal investigator, The Second Affiliated Hospital of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150377
- Sponsor's protocol ID
- MT-009
- Status last verified
- Aug 2025
- First submitted
- 24 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Lenvatinib and TACE for Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07150377
- Acronym / sponsor ID
- MT-009
- Conditions
- Hepatocellular Carcinoma (HCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Shandong First Medical UniversityUniversity, hospital or other
- Study start
- 24 Aug 2025 (estimated)
- Primary completion
- 24 Aug 2026 (estimated)
- Study completion
- 24 Aug 2028 (estimated)
- First posted
- 2 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.
To evaluate the efficacy of Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular carcinoma by assessing Progression-Free Survival (PFS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular car | Experimental | Drug: First-line Cohort, Drug: Second-line Cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- First-line Cohort:
- Confirmed diagnosis of HCC, aged > 18 years.
- Prior first-line therapy (including targeted therapy or immunotherapy).
- Child-Pugh class A/B at baseline.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment.
Key exclusion criteria (9 listed)
- Concomitant hepatic encephalopathy.
- History of any nephrotic syndrome.
- History of clinically significant cardiovascular disease or arterial thromboembolic events, including stroke, myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization.
- Evidence of any prior or current coagulopathy or bleeding diathesis, or any type of surgery performed within the past 28 days (biopsy is not excluded).
- History of abdominal fistula, gastrointestinal perforation, refractory non-healing gastric ulcer, or active gastrointestinal bleeding within 6 months prior to randomization.
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 |
|---|---|---|
| First-line CohortIparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd | Drug | Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular car |
| Second-line CohortIparomlimab and Tuvonralimab: 7.5 mg/kg, IV, Q3W Lenvatinib: 12 mg (for body weight ≥60 kg) or 8 mg (for body weight ≤60 kg), po, qd | Drug | Iparomlimab and Tuvonralimab in combination with Lenvatinib and TACE for advanced hepatocellular car |
Primary outcome
PFS
Time frame: 1 year
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
3 secondary outcomes
OS
Time frame: 2 years
Objective Response Rate
Time frame: 1 year
Adverse Events
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 2 Sep 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.
yan hai Liu principal investigator
The Second Affiliated Hospital of Shandong First Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing First-line Cohort and Second-line Cohort in people with Hepatocellular Carcinoma (HCC), run by The Second Affiliated Hospital of Shandong First Medical University.
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 13 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: opening soon, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Jun qi Yi, Doctor (18265384981, yiqijun1983@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 1 year). 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 2 Sep 2025.