HCCPhase 2NCT07099274
Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib in the Treatment of Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
A Phase 2 study testing lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib in people with HCC, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Major objectives To evaluate the efficacy of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC
- What is being tested?
- lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2025to 30 Dec 2029
- 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
- Comprehension and voluntary signing of the study's informed consent form;
- Age ≥18 years, any gender;
- Histologically or clinically confirmed hepatocellular carcinoma;
- Documented failure or intolerance to first-line therapy with PD-1/PD-L1 inhibitor plus bevacizumab;
- ECOG performance status 0-2;
- Child-Pugh class A or class B (score ≤7) without hepatic encephalopathy history;
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- Life expectancy ≥3 months;
- At least one measurable target lesion confirmed by screening imaging per RECIST v1.1;
- Adequate organ and bone marrow function within 7 days prior to initial study treatment;
- Active HBV/HCV infection requires ongoing antiviral therapy; k.Fertile patients must use highly effective contraception with partners during treatment and ≥180 days post-last dose.
- 2.Exclusion Criteria:
- Inability to comply with the study protocol or procedures;
- Histologically/cytologically confirmed fibrolamellar HCC, sarcomatoid HCC, cholangiocarcinoma, or mixed hepatocellular-cholangiocarcinoma;
- History of liver transplantation or planned transplantation;
- Presence of central nervous system metastases and/or leptomeningeal carcinomatosis;
- Baseline imaging showing Vp4 portal vein tumor thrombosis;
- Hypersensitivity to any study drug components or history of severe allergic reactions;
- Concurrent HBV and HCV co-infection;
- Clinically significant ascites requiring intervention during screening;
- Concurrent use of other investigational drugs or participation in another clinical trial within 4 weeks prior to enrollment;
- Esophageal/gastric variceal bleeding due to portal hypertension within 6 months before treatment initiation, or high-risk varices on endoscopy within 3 months;
- Current interstitial lung disease (ILD), history of steroid-required ILD, or other pulmonary fibrosis/organizing pneumonia affecting immune-related pulmonary toxicity assessment;
- Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg despite medication), coronary artery disease, arrhythmias, or heart failure (NYHA Class ≥II);
- Uncontrolled clinically significant infections requiring IV antimicrobial therapy;
- Proteinuria ≥2+ (≥1.0g/24h);
- History of hemorrhagic tendency regardless of severity within 2 months prior to enrollment;
- Arterial/venous thromboembolic events within 12 months before treatment initiation (e.g., cerebrovascular accident including TIA);
- Acute myocardial infarction, acute coronary syndrome, or CABG within 6 months before treatment;
- Unhealed fractures or chronic non-healing wounds;
- Coagulopathy, bleeding diathesis, or current therapeutic anticoagulation;
- Other malignancies within 5 years except curatively resected basal/squamous cell skin carcinoma or cervical carcinoma in situ;
- Active autoimmune disease or autoimmune disease history requiring immunosuppression within 4 weeks prior to enrollment;
- Prior allogeneic bone marrow or solid organ transplantation;
- Investigator assessment of ineligibility based on medical/safety reasons.
Who cannot join
None listed.
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300000
Tongguo Si, 18526812877, 18526812877@163.com
About this study
Official title: A Single-Arm, Single-Center Clinical Study Evaluating the Efficacy and Safety of Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib as Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
Major objectives To evaluate the efficacy of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma.
Read the detailed description
This single-arm, single-center clinical study aims to evaluate the efficacy and safety of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma. This study consists of three phases: screening, treatment, and follow-up. Efficacy evaluation and safety monitoring should be performed throughout the study.
- Conditions
- HCC
- Being tested
- lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib
- Keywords
- Iparomlimab and Tuvonralimab Injection, TACE, Lenvatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lparomlimab and Tuvonralimab Injection in Combination with TACE and LenvatinibDrug
lparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg/kg, q3w; Lenvatinib: 8 mg once daily for patients weighing <60 kg, or 12 mg once daily for those weighing ≥60 kg, administered orally, continuous daily dosing； TACE: Administered 4-6 times, using a combination of anthracyclines, lipiodol, and microspheres. The procedure should be performed within one week before or after QL1706 administration.
| Study group | Role | What they receive |
|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib | Experimental | lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib Receives: Drug: lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first.
Measured: up to 12 month
Secondary outcomes (5)
Objective response rate
the percentage of participants in the analysis population who had a CR (Disappearance of all target lesions) or a PR (≥30% decrease in SOD of target lesions) using RECIST 1.1 based on investigator assessment.
Measured: up to 12 month
Overall survival
OS was defined as the time from the first dose of study drug to death due to any cause.
Measured: up to 36 month
Disease Control Rate
DCR was defined as the percentage of participants in the analysis population who have CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) or SD (Neither sufficient shrinkage for PR nor sufficient increase for PD [at ≥20% increase in target lesion SOD and absolute SOD increase of ≥5 mm.
Measured: up to 12 month
Duration of Response
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigator assessment, DOR was defined as time from first documented CR or PR until PD or death, whichever occurs first.
Measured: up to 12 month
Adverse Events
An AE was defined as any untoward medical occurrence in a pharmaceutical product which does not necessarily have to have a causal relationship with this treatment.
Measured: up to 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start22 Aug 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099274
- Sponsor's protocol ID
- EC-2025-0041
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 29 Aug 2025
- 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 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Single-Center Clinical Study Evaluating the Efficacy and Safety of Lparomlimab and Tuvonralimab Injection in Combination With TACE and Lenvatinib as Second-Line Therapy for Unresectable Intermediate-to-Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07099274
- Acronym / sponsor ID
- EC-2025-0041
- Conditions
- HCC
- Keywords
- Iparomlimab and Tuvonralimab Injection, TACE, Lenvatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 1 Aug 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.
Major objectives To evaluate the efficacy of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma.
Detailed description
This single-arm, single-center clinical study aims to evaluate the efficacy and safety of lparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/ CTLA-4 Combined Antibody) in combination with TACE and lenvatinib as second-line therapy in patients with unresectable intermediate-to-advanced hepatocellular carcinoma. This study consists of three phases: screening, treatment, and follow-up. Efficacy evaluation and safety monitoring should be performed throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib | Experimental | Drug: lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatiniblparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (34 listed)
- Comprehension and voluntary signing of the study's informed consent form;
- Age ≥18 years, any gender;
- Histologically or clinically confirmed hepatocellular carcinoma;
- Documented failure or intolerance to first-line therapy with PD-1/PD-L1 inhibitor plus bevacizumab;
- ECOG performance status 0-2;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatiniblparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg/kg, q3w; Lenvatinib: 8 mg once daily for patients weighing <60 kg, or 12 mg once daily for those weighing ≥60 kg, administered orally, continuous daily dosing； TACE: Administered 4-6 times, using a combination of anthracyclines, lipiodol, and microspheres. The procedure should be performed within one week before or after QL1706 administration. | Drug | lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib |
Primary outcome
Progression-Free Survival (PFS)
Time frame: up to 12 month
PFS was defined as the time from first dose of study treatment to the first documented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whichever occurred first.
5 secondary outcomes
Objective response rate
Time frame: up to 12 month
Overall survival
Time frame: up to 36 month
Disease Control Rate
Time frame: up to 12 month
Duration of Response
Time frame: up to 12 month
Adverse Events
Time frame: up to 36 month
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 29 Aug 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.
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 lparomlimab and Tuvonralimab Injection in Combination with TACE and Lenvatinib in people with HCC, run by Tianjin Medical University Cancer Institute and 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 34 inclusion and 0 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 29 Aug 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 Tongguo Si, Doctor (+86 18526812877, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: up to 12 month). 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 29 Aug 2025.