Tianjin medical university institute & hospital
Tianjin, China
Location status: Recruiting
NCT Number: NCT07801287
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Tianjin, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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.
Interested in participating?
Request InfoTianjin Medical University Cancer Institute and Hospital
Other
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
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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