HCCPhase 2NCT07119931
A Clinical Study Evaluating HAIC Combined With Iparomlimab and Tuvonralimab Injection Plus Bevacizumab in Patients With Initially Potentially Resectable Hepatocellular Carcinoma (ITBHaic Study)
A Phase 2 study testing lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab in people with HCC, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
Major Objectives To evaluate the efficacy of HAIC combined with Iparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) plus bevacizumab as a conversion therapy in patients with potentially resectable HCC, assessed by the conversion resection rate. 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 HAIC and bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 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
- Subjects voluntarily join this study, sign the informed consent form, and demonstrate good compliance;
- Age ≥ 18 years, regardless of gender;
- HCC confirmed histologically/cytologically or meeting the clinical diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition), with no evidence of extrahepatic metastasis;
- Potentially resectable HCC must meet ALL of the following criteria:
- Deemed unsuitable for primary surgical resection at the current stage by the Multidisciplinary Team (MDT) assessment at the research center; b. At least one untreated measurable lesion according to RECIST v1.1 criteria. (Note: Subjects who received prior local therapy for non-target lesions are eligible. Local therapy must have been completed at least 4 weeks prior to baseline scans.); c. Largest tumor diameter ≥5 cm AND ≤3 tumor lesions; d. Absence of Vp3-Vp4 stage portal vein tumor thrombus (PVTT) as per the Japanese PVTT classification system; e. Oligometastasis is permitted;
- No prior systemic therapy for HCC (including investigational systemic agents);
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- Child-Pugh score class A or well-compensated class B (score ≤7);
- Subjects with HBV or HCV infection must meet the following criteria:
- 1) HBV-infected subjects (HBsAg positive or HBV-DNA positive): Must have received guideline-recommended antiviral therapy for at least 3 days prior to the first study treatment, demonstrating a decreasing trend in HBV-DNA levels. Must continue to receive standard antiviral therapy throughout the study period; 2) HCV-infected subjects (HCVAb positive or HCV RNA positive): Must be in a stable condition per investigator assessment. If receiving antiviral therapy, must continue treatment throughout the study period; 3) Co-infection with HBV and HCV is not allowed. (Note: A history of HCV infection with undetectable HCV-RNA is considered absence of current HCV infection); 8.ECOG Performance Status score of 0-1 (Appendix 1); 9.Life expectancy ≥3 months; 10.Adequate organ function within 7 days prior to treatment, meeting all the following criteria: Hemoglobin (Hb) ≥90 g/L; White blood cell count (WBC) ≥3.5 × 10⁹/L; Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Platelet count (PLT) ≥75 × 10⁹/L; AST and ALT ≤5 × upper limit of normal (ULN); Total bilirubin ≤3 × ULN; Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CrCl) ≥40 mL/min (Appendix 2); Urinalysis showing urine protein <2+(For subjects with baseline urinalysis showing urine protein ≥2+, a 24-hour urine collection must demonstrate 24-hour urine protein <1 g); Adequate coagulation function, defined as: International Normalized Ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5 × ULN; Normal thyroid function, defined as: Thyroid-stimulating hormone (TSH) within normal range. (Subjects with baseline TSH outside normal range may enroll if free triiodothyronine (FT3) or total T3 and free thyroxine (FT4) are within normal limits); 11.Male subjects and subjects of childbearing potential must use highly effective contraception from informed consent signing until 6 months after last study treatment. Subjects of childbearing potential must have a negative pregnancy test within 7 days prior to first treatment.
Who cannot join
- Pregnant or lactating women;
- Histologically/cytologically confirmed HCC containing fibrolamellar, sarcomatoid, or cholangiocarcinoma components;
- History of other primary malignancies within 5 years (except adequately treated and stable non-melanoma skin cancer, basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix);
- Current or prior central nervous system (CNS) metastases or leptomeningeal metastasis;
- Bleeding tendency, high bleeding risk, or coagulation dysfunction: including but not limited to thromboembolic events (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism) within 6 months prior to screening; and/or history of hemoptysis (≥2.5 ml bright red blood per episode) within 3 months prior to screening; current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for treatment; significant risk of gastrointestinal bleeding as judged by the investigator;
- Presence of unhealed fractures, wound dehiscence requiring intervention, wound healing complications; tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess within 6 months prior to screening;
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- Major surgery within 4 weeks before first dose (defined as Grade III or higher surgical procedures, excluding central venous catheter placement, tumor biopsy, etc.) or significant trauma with incomplete recovery;
- Significant cardiovascular diseases (e.g., NYHA Class II or higher heart failure, myocardial infarction, or cerebrovascular events within 3 months before initiating study treatment), unstable arrhythmias, or unstable angina;
- Active autoimmune diseases or history of autoimmune disorders including but not limited to interstitial pneumonia, uveitis, inflammatory bowel disease, hepatitis, hypophysitis, vasculitis, systemic lupus erythematosus; Note: Excludes hypothyroidism stabilized with physiologic hormone replacement, type I diabetes controlled with stable insulin therapy, or autoimmune thyroiditis managed with stable hormone replacement.
- Diagnosed immunodeficiency or anticipated need for systemic immunosuppressive therapy during study treatment, or prior use of systemic corticosteroids/immunosuppressants before first treatment; Note: Excludes topical/nasal/inhaled corticosteroids, physiologic systemic corticosteroids (≤10 mg/day prednisone equivalents), and transient corticosteroid use for COPD/asthma/allergy prophylaxis;
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia on screening chest CT scan;
- Severe infection within 4 weeks before initiating study treatment, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks before first dose (excluding antiviral therapy for HBV/HCV);
- Poorly controlled comorbidities despite optimal management before first treatment: Uncontrolled hyperglycemia (defined as fasting blood glucose ≥7 mmol/L, unstable oral hypoglycemic regimen, or unstable glycemic control per specialist assessment); Uncontrolled hypertension (SBP >150 mmHg and/or DBP >100 mmHg after ≥2 antihypertensive agents) or history of hypertensive crisis/encephalopathy; Refractory malignant pleural effusion, ascites, or pericardial effusion (defined as symptomatic re-accumulation requiring re-intervention within 2 weeks after drainage);
- Known hypersensitivity to the investigational drug or its excipients;
- Any other severe/uncontrolled comorbidity that may compromise safety or efficacy assessments per investigator judgment (e.g., hepatic encephalopathy, uncorrectable coagulopathy, hepatorenal syndrome, or cachexia).
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
Official title: A Single-Arm, Single-Center, Phase II Clinical Study Evaluating the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Iparomlimab and Tuvonralimab Injection Plus Bevacizumab in Patients With Initially Potentially Resectable Hepatocellular Carcinoma (ITBHaic Study)
Major Objectives To evaluate the efficacy of HAIC combined with Iparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) plus bevacizumab as a conversion therapy in patients with potentially resectable HCC, assessed by the conversion resection rate.
Read the detailed description
This single-center, single-arm, phase II clinical study aims to evaluate the efficacy and safety of HAIC combined with Iparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) plus bevacizumab in patients with potentially resectable HCC. The study consists of four periods: screening, treatment, safety follow-up, and survival follow-up.Efficacy evaluation and safety monitoring should be performed throughout the study.
- Conditions
- HCC
- Being tested
- lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab
- Keywords
- lparomlimab and Tuvonralimab Injection, HAIC, bevacizumab
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 HAIC and bevacizumabDrug
Iparomlimab and Tuvonralimab Injection（Q1706）: 7.5 mg/kg, q3w, given on Day 1 (±7 days) of each 21-day cycle; Bevacizumab: 7.5 mg/kg, q3w, administered on Day 1 (±7 days) of each 21-day cycle; HAIC:Oxaliplatin 85 mg/m² via arterial infusion over 2-3 hours, Levoleucovorin 200 mg/m² via arterial infusion over 1-2 hours, 5-Fluorouracil 400 mg/m² via arterial bolus injection, followed by continuous arterial infusion of 2400 mg/m² over 23 hours, q3w, with the treatment interval not exceeding 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab | Experimental | lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab Receives: Drug: lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion resection rate
The percentage of initially unresectable patients who underwent curative resection after protocol-specified conversion therapy.
Measured: up to 12 month
Secondary outcomes (12)
R0 Resection Rate
Proportion of patients achieving complete tumor resection with microscopically negative margins after successful conversion therapy
Measured: up to 12 month
Pathological Complete Response
The proportion of patients in whom no residual viable tumor cells are detected upon histopathological examination of the surgically resected specimen.
Measured: up to 12 month
Major Pathological Response
the proportion of patients with significantly reduced residual viable tumor cells in the surgically resected specimens (typically defined as ≤50% residual viable tumor cells, according to the Chinese Expert Consensus on Conversion and Perioperative Therapy for Primary Liver Cancer (2024 Edition)).
Measured: up to 12 month
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) usingRECIST1.1 based oninvestiqator assessment
Measured: up to 12 month
Disease Control Rate
DCR was defined as the percentage of participants in the analysis population whohave CR (Disappearance of all target lesions) or PR (≥30% decrease in SOD of target lesions) orSD (Neither sufficient shrinkage for PR nor sufficient increase for PD lat ≥20% increase in targetlesion 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 targetlesions) or PR (≥30% decrease in SOD of target lesions) per RECIST 1.1 by investigatorassessment, DOR was defined as time from first documented CR or PR until PD or deathwhichever occurs first.
Measured: up to 12 month
Progression-Free Survival (PFS)
PFS was defined as the time from first dose of study treatment to the firstdocumented PD per RECIST 1.1 by investigator assessment, or death due to any cause, whicheveroccurred first.
Measured: up to 12 month
Recurrence-Free Survival
The time from treatment initiation to the first recurrence or death from any cause, whichever occurs first.
Measured: up to 36 month
Time To Progression
the time from randomization to disease progression per investigator-assessed RECIST 1.1. Death without progression will be censored at last tumor 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 anycause.
Measured: up to 36 month
Time To Deterioration
the time from treatment initiation to first deterioration (i.e., a ≥10-point decrease from baseline in the EORTC QLQ-C30 global score).
Measured: up to 12 month
Symptom Improvement Rate
the number of subjects with "improvement" (≥10-point decrease in symptom score from baseline) achieving best overall response divided by the number of subjects with baseline symptom score ≥10;
Measured: up to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start10 Sep 2025 (estimated)
- 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
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119931
- Sponsor's protocol ID
- EC-2025-0126
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 13 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 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Single-Center, Phase II Clinical Study Evaluating the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy (HAIC) Combined With Iparomlimab and Tuvonralimab Injection Plus Bevacizumab in Patients With Initially Potentially Resectable Hepatocellular Carcinoma (ITBHaic Study)
- ClinicalTrials.gov ID
- NCT07119931
- Acronym / sponsor ID
- EC-2025-0126
- Conditions
- HCC
- Keywords
- lparomlimab and Tuvonralimab Injection, HAIC, bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 10 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 13 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 HAIC combined with Iparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) plus bevacizumab as a conversion therapy in patients with potentially resectable HCC, assessed by the conversion resection rate.
Detailed description
This single-center, single-arm, phase II clinical study aims to evaluate the efficacy and safety of HAIC combined with Iparomlimab and Tuvonralimab injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) plus bevacizumab in patients with potentially resectable HCC. The study consists of four periods: screening, treatment, safety follow-up, and survival 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 HAIC and bevacizumab | Experimental | Drug: lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumablparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab |
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 join this study, sign the informed consent form, and demonstrate good compliance;
- Age ≥ 18 years, regardless of gender;
- HCC confirmed histologically/cytologically or meeting the clinical diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition), with no evidence of extrahepatic metastasis;
- Potentially resectable HCC must meet ALL of the following criteria:
- No prior systemic therapy for HCC (including investigational systemic agents);
Key exclusion criteria (15 listed)
- Pregnant or lactating women;
- Histologically/cytologically confirmed HCC containing fibrolamellar, sarcomatoid, or cholangiocarcinoma components;
- History of other primary malignancies within 5 years (except adequately treated and stable non-melanoma skin cancer, basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix);
- Current or prior central nervous system (CNS) metastases or leptomeningeal metastasis;
- Bleeding tendency, high bleeding risk, or coagulation dysfunction: including but not limited to thromboembolic events (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism) within 6 months prior to screening; and/or history of hemoptysis (≥2.5 ml bright red blood per episode) within 3 months prior to screening; current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for treatment; significant risk of gastrointestinal bleeding as judged by the investigator;
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 HAIC and bevacizumabIparomlimab and Tuvonralimab Injection（Q1706）: 7.5 mg/kg, q3w, given on Day 1 (±7 days) of each 21-day cycle; Bevacizumab: 7.5 mg/kg, q3w, administered on Day 1 (±7 days) of each 21-day cycle; HAIC:Oxaliplatin 85 mg/m² via arterial infusion over 2-3 hours, Levoleucovorin 200 mg/m² via arterial infusion over 1-2 hours, 5-Fluorouracil 400 mg/m² via arterial bolus injection, followed by continuous arterial infusion of 2400 mg/m² over 23 hours, q3w, with the treatment interval not exceeding 4 weeks. | Drug | lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab |
Primary outcome
Conversion resection rate
Time frame: up to 12 month
The percentage of initially unresectable patients who underwent curative resection after protocol-specified conversion therapy.
12 secondary outcomes
R0 Resection Rate
Time frame: up to 12 month
Pathological Complete Response
Time frame: up to 12 month
Major Pathological Response
Time frame: up to 12 month
Objective response rate
Time frame: up to 12 month
Disease Control Rate
Time frame: up to 12 month
Duration of Response
Time frame: up to 12 month
Progression-Free Survival (PFS)
Time frame: up to 12 month
Recurrence-Free Survival
Time frame: up to 36 month
Time To Progression
Time frame: up to 12 month
Overall survival
Time frame: up to 36 month
Time To Deterioration
Time frame: up to 12 month
Symptom Improvement Rate
Time frame: up to 12 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 13 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lparomlimab and Tuvonralimab Injection in Combination with HAIC and bevacizumab in people with HCC, run by Tianjin Medical University Cancer Institute and Hospital.
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 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: opening soon, as of the sponsor's last update on 13 Aug 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 Huikai Li, Doctor (+8618526812877, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conversion resection rate (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 13 Aug 2025.