A Single-Arm, Multicenter, Exploratory Clinical Study of TACE Combined With Iparomlimab and Tuvonralimab Injection (QL1706) and Lenvatinib for Perioperative Treatment of Resectable Hepatocellular Carcinoma

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Aug 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination of treatments for people with a type of liver cancer called hepatocellular carcinoma (HCC) that can be removed by surgery. The study is testing whether giving a procedure called TACE (which blocks the blood supply to the tumor) along with two immune-boosting medicines (Iparomlimab and Tuvonralimab) and a targeted drug called lenvatinib before and around the time of surgery can help improve treatment outcomes. The main goal is to see how well this combination works in shrinking the tumor before surgery.

People who might be eligible for this study are adults aged 18 to 75 who have a confirmed diagnosis of liver cancer that can be surgically removed and meet certain risk criteria. Participants should be in good overall health, have good liver function, and not have had prior treatments like chemotherapy or immunotherapy for their cancer. If accepted, participants will receive the study treatments and be closely monitored for safety and how well the treatment works. This trial is still not recruiting yet, but if you or a loved one fits these criteria, discussing this option with a healthcare provider might be worthwhile.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily participate, sign ICF, demonstrate good expected compliance, and be willing to cooperate with follow-up.
• • 2. Age 18-75 years, any gender.
• • 3. HCC diagnosis confirmed by histopathology, cytology, or imaging.
• • 4. Resectable HCC staged as CNLC IIb-IIIa (excluding Vp3 and Vp4) or CNLC Ib-IIa with high-risk recurrence factors, confirmed by multidisciplinary liver surgery expert panel.
• • 5. For CNLC Ib-IIa subjects, presence of at least ONE high-risk recurrence factor.
• • 6. No prior systemic therapy for HCC (chemotherapy, targeted therapy, immunotherapy, etc.). Subjects with prior curative surgery or ablation are eligible only if recurrence occurred \>2 years post-resection. Subjects with prior other local therapies are excluded.
• • 7. Child-Pugh class A.
• • 8. ECOG PS score 0-1.
• • 9. Expected survival ≥12 months.
• • 10. Adequate organ function within 7 days prior to study intervention.
• • 11. For subjects with HBV infection.
• • 12. Women of childbearing potential: Must agree to abstinence or use highly effective contraception from ICF signing until ≥120 days after last study drug dose. Negative pregnancy test within 7 days prior to intervention. Not breastfeeding.
• • 13. Male subjects with WOCBP partners: Must agree to abstinence or use highly effective contraception from ICF signing until ≥120 days after last study drug dose. Must not donate sperm during this period. Males with pregnant partners must use condoms.
• Exclusion Criteria:
• • 1. Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed carcinoma (\>30% ICC component), or fibrolamellar carcinoma. Active malignancy other than HCC within 5 years or concurrently. Cured localized cancers are eligible.
• • 2. Current or history of interstitial lung disease/pneumonitis requiring steroids, or other active lung disease potentially interfering with immune-related pulmonary toxicity evaluation/management, or active pneumonia/severe impaired pulmonary function on screening CT. Active tuberculosis.
• • 3. Active autoimmune disease or history of autoimmune disease with potential recurrence. Vitiligo, psoriasis, alopecia not requiring systemic therapy, controlled Type I diabetes on insulin, or childhood asthma resolved in adulthood without intervention are eligible. Asthma requiring bronchodilators is excluded.
• • 4. Systemic immunosuppressive therapy (\>10 mg/day prednisone equivalent) within 2 weeks prior to intervention.
• • 5. Active infection, unexplained fever ≥38.5°C within 1 week prior, or baseline WBC \>15 × 10⁹/L. Therapeutic antibiotics (IV/oral) within 2 weeks prior (prophylactic IV antibiotics ≤48h duration allowed).
• • 6. Primary or acquired immunodeficiency.
• • 7. Live attenuated vaccine within 4 weeks prior to intervention or anticipated need during study or within 60 days after last Iparomlimab and Tuvonralimab Injection dose.
• • 8. Significant bleeding symptoms or predisposition within 6 months prior. If baseline fecal occult blood positive, repeat test; if still positive, requires gastroscopy.
• • 9. Known hereditary/acquired bleeding/thrombotic diathesis. Current therapeutic-dose anticoagulants/thrombolytics (prophylactic low-dose aspirin allowed).
• • 10. Arterial thromboembolic events within 6 months prior.
• • 11. Poorly controlled cardiac disease.
• • 12. Hypertension uncontrolled by medication (average SBP ≥140 mmHg or DBP ≥90 mmHg on ≥2 readings). History of hypertensive crisis or encephalopathy.
• • 13. Major vascular disease within 6 months prior.
• • 14. Serious unhealed wounds, active ulcers, or untreated fractures.
• • 15. Major surgery within 4 weeks prior or anticipated major surgery during study.
• • 16. Inability to swallow pills, malabsorption syndrome, or GI condition affecting absorption.
• • 17. Bowel obstruction or related symptoms/signs within 6 months prior requiring parenteral support/feeding. Subjects with prior resolved obstruction treated definitively (surgically) may be eligible after assessment.
• • 18. Strong CYP3A4 inducers within 2 weeks prior or strong CYP3A4 inhibitors within 1 week prior.
• • 19. Known hypersensitivity to any study drug or excipient.
• • 20. Participation in another investigational drug study within 4 weeks prior.
• • 21. Pregnancy or lactation.
• • 22. Any other condition deemed unsuitable by the investigator.