Neoadjuvant Therapy of Iparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma

NCT07014150 | Recruiting Phase 2 DMC

• 1 other identifier: QBA001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hepatocellular Carcinoma Resectable

Keywords

iIparomlimab and Tuvonralimab; lenvatinib; neoadjuvant therapy; high-risk recurrence; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Major Pathological response

  after surgery immediately

Secondary Outcomes (7)

• Overall survival

  12 months after the last subject is enrolled

• Recurrence free survival

  12 months after the last subject is enrolled

• Disease control rate

  From enrollment to the end of treatment at 9 weeks

• objective remission rate

  From enrollment to the end of treatment at 9 weeks

• Progression free survival

  12 months after the last subject is enrolled

Study Arms (1)

Combination medication group

EXPERIMENTAL

Iparomlimab and Tuvonralimab every 21 days up to 3cycles, 7.5mg/kg; Combined with lenvatinib, QD, 8mg/ day for less than 60kg, 12mg/ day for more than 60kg, up to 9 weeks.

Drug: Lenvatinib; Drug: Iparomlimab and Tuvonralimab

Interventions

Lenvatinib DRUG

daily,8mg/ day for less than 60kg, 12mg/ day for more than 60kg, for 9 weeks

Combination medication group

Iparomlimab and Tuvonralimab DRUG

7.5mg/kg, every 3 weeks, for 3cycles.

Combination medication group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up
• Be at least 18 years old at the time of signing the informed consent form, with no gender restrictions.
• Hepatocellular carcinoma diagnosed by histology or imaging
• At least one measurable lesion (according to the requirements of RECIST version 1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10mm or the short diameter of the enlarged lymph node is ≥15mm)
• No systematic treatment has been received before
• CNLC：Ib to IIIa
• There is at least one of the following high-risk factors for postoperative recurrence: AFP\>400ng/ml; Single tumor \>5cm; The number of tumors is greater than 3 or any one of them is greater than 3cm; There are vascular tumor thrombus or tumors adjacent to large blood vessels, etc.
• The ECOG score was 0-1 within one week before enrollment
• Hematology and organ functions are adequate
• Fertile women: Agree to abstain from sex (avoid heterosexual intercourse) or use contraceptive methods with an annual contraceptive failure rate of less than 1% during the treatment period and for at least 6 months after the last administration

You may not qualify if:

• Have received any systemic treatment
• ECOG score \>1
• Definite extrahepatic metastasis
• Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women
• Those who are known to be allergic or intolerant to recombinant humanized PD-1 monoclonal antibody drugs and their components (or any excipients)
• Previous or existing grade 3 or above digestive tract fistulas or non-digestive tract fistulas (such as skin) as defined by CTCAE 5.0 criteria
• Major surgical operations (except biopsy) have been performed within 4 weeks before the first study of drug treatment or the surgical incision has not fully healed
• Cardiovascular and cerebrovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction and severe/unstable angina pectoris that occurred within 6 months before enrollment
• Insufficiency of liver and kidney functions, such as jaundice, ascites, and/or bilirubin \>3×ULN, creatinine ratio \>3.5g/24 hours, etc
• Persistent infection of grade \>2 (CTCAE 5.0)
• A history of thromboembolism (including stroke and/or transient ischemic attack) within the past 6 months
• Hypertension that has not been well controlled after antihypertensive drug treatment (systolic blood pressure \>160mmHg, diastolic blood pressure \>100mmHg)
• An active autoimmune disease or a history of autoimmune diseases in the past two years
• Active central nervous system (CNS) metastases and/or cancerous meningitis
• Be ready or have received organ or allogeneic bone marrow transplants before

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Chinese Academy of Medical Sciences，Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (2)

• Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1.

  PMID: 37158938 BACKGROUND

• Lou, H. et al. Efficacy and safety of iparomlimab and tuvonralimab in previously treated patients with recurrent or metastatic cervical cancer: a multicenter, open-label, single-arm, phase 2 clinical trial (DUBHE-C-206). Int. J. Gynecol. Cancer 34, (2024)

  BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Chengjie Li

CONTACT

86+13733879582; 1624271942@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 10, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)