Actively Recruiting
Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma
Led by Peking Union Medical College Hospital · Updated on 2026-05-05
33
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if the neoadjuvant therapy of iIparomlimab and Tuvonralimab plus lenvatinib works to treat hepatocellular carcinoma(HCC) patients with high risk of recurrence. It will also learn about the safety of the combination of iIparomlimab and Tuvonralimab plus lenvatinib. The main questions it aims to answer are: Does the combination therapy improve the major pathological response rate and reduce the risk of disease recurrence or progression in HCC patients? What medical problems do participants have when taking this combination regimen? Researchers will compare this combination to previous studies to evaluate its efficacy and safety in managing HCC. Participants will: Take iIparomlimab and Tuvonralimab every 3 weeks for three times and lenvatinib everyday for 9 weeks. Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms and the number of times when taking the combination regimen.
CONDITIONS
Official Title
Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- At least 18 years old with no gender restrictions
- Diagnosed with hepatocellular carcinoma by histology or imaging
- Have at least one measurable lesion meeting RECIST 1.1 criteria
- Have not received any prior systemic treatment
- Classified as CNLC stage Ib to IIIa
- Have at least one high-risk factor for postoperative recurrence such as AFP > 400 ng/ml, single tumor > 5 cm, more than 3 tumors or any tumor > 3 cm, or vascular tumor thrombus or tumor adjacent to major vessels
- ECOG performance status score of 0 or 1 within one week before enrollment
- Adequate hematology and organ function
- Fertile women agree to abstain from sex or use effective contraception during treatment and for at least 6 months after last dose
You will not qualify if you...
- Have received any prior systemic treatment
- ECOG performance status score greater than 1
- Definite extrahepatic metastasis
- Pregnant or breastfeeding women
- Known allergy or intolerance to recombinant humanized PD-1 monoclonal antibody drugs or their components
- History of grade 3 or higher digestive or non-digestive tract fistulas
- Major surgery within 4 weeks before starting study treatment or unhealed surgical incision
- Significant cardiovascular or cerebrovascular disease within 6 months prior to enrollment
- Severe liver or kidney dysfunction such as jaundice, ascites, or elevated bilirubin or creatinine
- Persistent infection of grade 2 or higher
- History of thromboembolism within past 6 months
- Uncontrolled hypertension after treatment
- Active or history of autoimmune disease in past 2 years
- Active central nervous system metastases or cancerous meningitis
- Prior organ or bone marrow transplant
- Active tuberculosis
- Recent history or tendency toward gastrointestinal bleeding
- HIV infection
- Active hepatitis B or C without regular treatment or high HBV DNA levels not reduced before enrollment
- Drug abuse or medical, psychological, or social conditions affecting compliance or safety
- Unresolved toxicity from previous treatments above grade 1 (except alopecia, anemia, hypothyroidism)
- Severe lung function impairment or history of severe pulmonary diseases
- Recent use of potent CYP3A4 inhibitors within 7 days
- Other untreated or active malignant tumors within past 5 years (some exceptions apply)
- Determined unsuitable by researchers
- Participation in another clinical study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Sciences，Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
C
Chengjie Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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