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NCT Number: NCT07801287

Iparomlimab/Tuvonralimab Plus SBRT and Lenvatinib for Perioperative Treatment of Potentially Resectable Intermediate-Stage HCC

This study aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (the combination antibody) combined with SBRT and Lenvatinib in the perioperative treatment of patients with potentially resectable intermediate-stage hepatocellular carcinoma.. The objective is to explore potential survival benefits for this population and provide patients with more effective treatment options.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin medical university institute & hospital

Tianjin, China

Location status: Recruiting

Location contact

Maobin Meng

CONTACT

[email protected]

022-23340123

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand and voluntarily sign the informed consent form for this study. · Age ≥18 years old, male and female. · Pathologically or clinically confirmed potentially resectable intermediate-stage hepatocellular carcinoma (stage IIIa). · ECOG performance status of 0-1; · Child-Pugh score <7. · No prior anti-tumor treatment; · Expected survival ≥3 months; · At least one measurable target lesion confirmed by imaging examination during the screening period, according to RECIST v1.1 criteria; · Adequate organ and bone marrow function within 7 days prior to the first administration of study drug.· If HBV or HCV infection is present, the patient must be receiving regular treatment.· Fertile eligible patients must agree to use reliable contraceptive methods with their partner during the trial and for at least 180 days after the last dose of study drug.

Exclusion criteria

  • Unable to comply with the study protocol or study procedures;· Histologically or cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, combined hepatocellular-cholangiocarcinoma (mixed hepatocellular carcinoma), or other similar types; · Presence of extrahepatic metastatic lesions; · History of liver transplantation, or planned liver transplantation; · Evidence of central nervous system metastasis, and/or patients with carcinomatous meningitis; · History of hypersensitivity to the study drug or its formulation components, or known allergic diathesis; · Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV); · Presence of ascites requiring clinical intervention, or uncontrolled pleural effusion, pericardial effusion of moderate or greater amount, etc., as confirmed by screening examinations; · History of esophageal or gastric variceal bleeding due to portal hypertension within 6 months prior to the first dose of study drug, or known severe varices on endoscopy within 3 months prior to the first dose of study drug; · Current interstitial pneumonia or interstitial lung disease, or history of interstitial pneumonia or interstitial lung disease requiring corticosteroid treatment, or other pulmonary fibrosis or organizing pneumonia that may interfere with the assessment and management of immune-related pulmonary toxicity; · Obvious bleeding tendency or other evidence of significant coagulation disorders; · History of severe cardiovascular or cerebrovascular disease; · History of other malignancies within 5 years prior to enrollment, except for radically resected basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ; · Active autoimmune disease within 4 weeks prior to enrollment, or history of autoimmune disease; · Prior allogeneic bone marrow transplantation or organ transplantation; · Patients considered by the investigator to be unsuitable for enrollment in this study.

Treatment and study plan

Iparomlimab/Tuvonralimab plus SBRT and Lenvatinib

Combination Product

Iparomlimab/Tuvonralimab: Intravenous infusion of 7.5 mg/kg repeated every 21 days as one cycle. Administration for 2-3 cycles before sugery and continuously for one year after surgery.

Lenvatinib: orally at a dose of 8 mg once daily (for patients with body weight <60 kg) or 12 mg once daily (for patients with body weight ≥60 kg), and taken continuously for one year after surgery.

Stereotactic body radiation therapy: 40-45 Gy/5F, once daily, 1-2 weeks before Iparomlimab/Tuvonralimab.

Surgery will be performed within 4-6 weeks after the last dose of conversion therapy, with a maximum of 12 weeks.

Primary outcomes

  1. Incidence of TEAEs

    Time frame: From date of randomization until the occurrence of adverse events assessed up to 24 months

    including adverse events and their severity (classified according to CTCAE v5.0), frequency of occurrence, etc.

Secondary outcomes

  1. Rate of R0 Resection

    Time frame: From date of randomization until the completion of operation assessed about 6 months

    The proportion of patients in whom the tumor is completely removed with no residual microscopic disease (negative surgical margins).

  2. Event-Free Survival

    Time frame: From date of randomization until disease progression, recurrence, death, or treatment failure assessed up to 24 months

    The time from randomization to the occurrence of any predefined event, which may include disease progression, recurrence, death, or treatment failure.

Study contacts

Contact information is provided by the study sponsor or research team.

Maobin Meng

CONTACT

[email protected]

022-23340123

Tianqiang Song

CONTACT

022-23340123

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

A Single-Arm, Single-Center Clinical Trial Evaluating Efficacy and Safety of Iparomlimab/Tuvonralimab Plus Stereotactic Body Radiation Therapy and Lenvatinib for Perioperative Treatment of Potentially Resectable Intermediate-Stage Hepatocellular Carcinoma

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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