AzTrials
AzTrials

Hepatocellular Carcinoma ResectablePhase 2NCT07014150

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

A Phase 2 study testing Lenvatinib and Iparomlimab and Tuvonralimab in people with Hepatocellular Carcinoma Resectable, run by Peking Union Medical College Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma Resectable
What is being tested?
Lenvatinib and Iparomlimab and Tuvonralimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
10 Jun 2025to 31 May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • Known history of active tuberculosis (Mycobacterium tuberculosis)
  • A history of gastrointestinal bleeding within the past 6 months or a clear tendency towards gastrointestinal bleeding
  • History of human immunodeficiency virus (HIV) infection
  • Positive for active hepatitis B or hepatitis C and has not received regular treatment. During the screening period, HBV DNA≥2000 IU/ml (or ≥104 copy number /ml), entecavir must be used to reduce it to <2000 IU/ml (or < 104 copy number /ml) before enrollment
  • There is drug abuse; Or any medical, psychological or social conditions that may affect the research, cause unstable patient compliance, or even endanger patient safety
  • Unresolved toxicity of grade > 1 due to any previous treatment/procedure (CTCAE 5.0, excluding alopecia, anemia, and hypothyroidism).
  • Patients with objective evidence of severe lung function impairment in the past or at present, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, and drug-related pneumonia
  • Received treatment with potent CYP3A4 inhibitors within 7 days before participating in the study
  • Accompanied by other malignant tumors, but having had other untreated malignant tumors in the past (within 5 years) or simultaneously, for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix, treated superficial bladder cancer and prostate adenocarcinoma that has undergone surgical treatment and whose PSA tumor markers are within the normal range.
  • After a comprehensive assessment of the patient's condition by the researchers, it was determined that they were not suitable to participate in this research
  • Participate in another clinical study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chengjie Li contact

86+13733879582

1624271942@qq.com

China1 site, 1 recruiting

  • Chinese Academy of Medical Sciences，Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100000

    Jiayue Li, 86+010-6915687, 1624271942@qq.com

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Study on the Neoadjuvant Therapy of iIparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma

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.

Read more

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.

Read the detailed description

This study is a single-center, single-arm, open-label phase II clinical trial, aiming to evaluate the impact of the neoadjuvant treatment regimen ofIparomlimab and Tuvonralimab plus lenvatinib on postoperative recurrence, survival, and drug safety in patients with hepatocellular carcinoma. Primary objective: Major Pathological response Secondary objectives: Efficacy indicators: Pathological complete response, progression-free survival, overall survival, recurrence-free survival, objective response rate, disease control rate. Safety indicators: Vital signs, laboratory parameters, adverse events (AE), serious adverse events (SAE), drug-related AE and SAE, and specific AE of this type of drug. Exploratory objective: To explore the impact of the combined treatment regimen on the tumor immune microenvironment in tumor tissues and peripheral blood of patients.

The target patients are：Patients with hepatocellular carcinoma (HCC) in CNLC stage Ib to IIIa who have at least one of the following high-risk factors for postoperative recurrence: AFP > 400 ng/ml; a single tumor > 5 cm; more than 3 tumors or any one of them > 3 cm; presence of vascular tumor thrombus or tumor adjacent to major vessels, etc.

Researchers will recruit 30 patients who will receive:

Iparomlimab and Tuvonralimab at 7.5 mg/kg administered intravenously every three weeks (q3w) for three cycles; Lenvatinib orally at 8 mg/day for patients weighing ≤60 kg and 12 mg/day for those >60 kg, taken daily for 9 weeks.

Researchers will evaluate whether the combination therapy improve the major pathological response rate and reduce the risk of disease recurrence or progression in HCC patients.

Being tested
Lenvatinib, Iparomlimab and Tuvonralimab
Keywords
iIparomlimab and Tuvonralimab, lenvatinib, neoadjuvant therapy, high-risk recurrence, hepatocellular carcinoma
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

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

  • Iparomlimab and TuvonralimabDrug

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

Study groups in NCT07014150
Study groupRoleWhat they receive
Combination medication groupExperimentalIparomlimab 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.
Receives: Drug: Lenvatinib; Drug: Iparomlimab and Tuvonralimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Pathological response

    Measured: after surgery immediately

Secondary outcomes (7)

  1. Overall survival

    Measured: 12 months after the last subject is enrolled

  2. Recurrence free survival

    Measured: 12 months after the last subject is enrolled

  3. Disease control rate

    Measured: From enrollment to the end of treatment at 9 weeks

  4. objective remission rate

    Measured: From enrollment to the end of treatment at 9 weeks

  5. Progression free survival

    Measured: 12 months after the last subject is enrolled

  6. Pathological complete response

    Measured: after surgery immediately

  7. Safety evaluation

    Measured: From enrollment to the end of treatment at 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study start10 Jun 2025
  3. Primary completion1 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07014150
Sponsor's protocol ID
QBA001
Status last verified
May 2025
First submitted
29 May 2025
Last updated
5 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: contact with investivator

Publications

  • 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.

    PubMed 37158938

  • 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)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib and Iparomlimab and Tuvonralimab in people with Hepatocellular Carcinoma Resectable, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chengjie Li (86+13733879582, 1624271942@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathological response (time frame: after surgery immediately). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07014150, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in