NCT07801287 Iparomlimab/Tuvonralimab Plus SBRT and Lenvatinib for Perioperative Treatment of Potentially Resectable Intermediate-Stage HCC
| NCT ID | NCT07801287 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | HCC - Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2028-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-09-01 with a primary completion date of 2028-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07801287 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HCC - Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07801287 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07801287 currently recruiting?
Yes, NCT07801287 is actively recruiting participants. Contact the research team at mmeng@tmu.edu.cn for enrollment information.
Where is the NCT07801287 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07801287 clinical trial?
NCT07801287 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 20 participants.
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