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HCC - Hepatocellular CarcinomaPhase 2NCT07515469

A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk

A Phase 2 study testing Iparomlimab and Tuvonralimab in people with HCC - Hepatocellular Carcinoma and Iparomlimab and Tuvonralimab Injection, run by Tianjin Medical University Cancer Institute and Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA). Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Iparomlimab and Tuvonralimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
30 May 2026to 30 Oct 2030
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

  • Patients voluntarily participate in this study and sign the informed consent form.
  • Aged 18 to 75 years, male or female.
  • ECOG Performance Status (PS) score of 0 to 1.
  • Child-Pugh liver function classification: Grade A.
  • Histopathologically confirmed primary hepatocellular carcinoma (HCC), and the lesions meet the surgical resection indications specified in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition).
  • Preoperatively, evaluated by the investigator, with high recurrence risk factors, meeting at least one of the following: Stage IB: Single tumor with maximum diameter > 5 cm; 2-3 tumors with maximum tumor diameter ≤ 3 cm；Stage IIA: 2-3 tumors with maximum tumor diameter > 3 cm.
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  • According to the RECIST 1.1 criteria, the patient has at least one measurable lesion (measurable lesion with a long diameter ≥ 10 mm on CT/MRI scan or lymph node lesion with a short diameter ≥ 15 mm on CT/MRI scan, and the measurable lesion has not received local treatment such as radiotherapy or cryotherapy).
  • Expected survival time ≥ 6 months
  • possess normal and sound organ function
  • Females of childbearing age must agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the medication period and within 6 months after the end of medication; serum or urine pregnancy test is negative within 7 days before study enrollment, and must be a non-lactating patient; males must agree to use contraceptive measures during the study period and within 6 months after the end of the study.
  • The subject has good compliance and is willing to cooperate with follow-up.

Who cannot join

  • Previous radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapy.
  • Known hilar cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar carcinoma; other active malignant tumors except HCC within 5 years or concurrently.
  • Hypertension that cannot be well controlled with antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy.
  • The subject has a history of other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) or concurrent malignant tumors.
  • Previous treatment with Iparomlimab and Tuvonralimab or other PD-1/PD-L1/CTLA-4 inhibitors; known previous allergy of the subject to macromolecular protein preparations or any component of Iparomlimab and Tuvonralimab.
  • The subject has any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or asthma that was completely relieved in childhood and does not require any intervention in adulthood can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.
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  • The subject is using immunosuppressants, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose > 10 mg/day prednisone or other hormones with equivalent efficacy), and continues to use them within 2 weeks before enrollment.
  • Clinically symptomatic ascites or pleural effusion requiring therapeutic paracentesis or drainage.
  • Uncontrolled clinical symptoms or diseases of the heart, such as: Heart failure of NYHA Class II or above；Unstable angina pectoris；Myocardial infarction within 1 year；Patients with clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
  • The patient currently (within 3 months) has esophageal varices, active gastroduodenal ulcer, ulcerative colitis, portal hypertension and other digestive tract diseases, or active bleeding from unresected tumors, or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.
  • Previous or current severe bleeding (bleeding > 30 ml within 3 months), hemoptysis (> 5 ml of fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months.
  • The subject has an active infection or unexplained fever > 38.5 ℃ during screening or before the first dose (fever caused by tumor can be included as judged by the investigator).
  • Patients with objective evidence of previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.
  • The subject has congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria; for hepatitis B: HBV DNA ≥ 10⁴/ml; for hepatitis C: HCV RNA ≥ 10³/ml); chronic hepatitis B virus carriers with HBV DNA < 2000 IU/ml (< 10⁴ copies/ml) can be enrolled only if they receive antiviral treatment during the trial.
  • Live vaccine接种 within 4 weeks before study medication or likely to be vaccinated during the study period.
  • The subject has a known history of psychotropic drug abuse, alcoholism or drug addiction.
  • The investigator deems that the subject should be excluded from this study, for example, as judged by the investigator, the subject has other factors that may lead to the forced termination of the study in the middle, such as other serious diseases (including mental diseases) requiring combined treatment, severe laboratory test abnormalities, or family or social factors that may affect the safety of the subject or the collection of data and samples.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Long Chun Zhang, doctor contact

+86 13011290101

asif@pku.org.cn

About this study

Official title: A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With Iparomlimab and Tuvonralimab Injection, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk

This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA).

Being tested
Iparomlimab and Tuvonralimab
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Iparomlimab and TuvonralimabDrug

    Patients in the neoadjuvant Iparomlimab and Tuvonralimab group received 2 cycles of 7.5 mg/kg iv d1 q3w, followed by elective surgery 2-3 weeks thereafter.

Study groups in NCT07515469
Study groupRoleWhat they receive
AExperimentalneoadjuvant Iparomlimab and Tuvonralimab group
Receives: Drug: Iparomlimab and Tuvonralimab

What is being measured

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

  1. 1-year disease-free survival rate

    To measure and report the proportion of patients alive and free of disease recurrence, metastasis, or death within 1 year after radical resection.

    Measured: 2 years

Secondary outcomes (6)

  1. Incidence of microvascular invasion (MVI)

    To evaluate and report the presence or absence of microvascular invasion in postoperative pathological specimens, and to report the overall incidence rate.

    Measured: 2 years

  2. Pathological complete response (pCR) rate

    To measure and report the proportion of patients achieving no residual viable tumor cells in resected hepatic specimens after neoadjuvant therapy.

    Measured: 2 years

  3. Objective response rate (ORR)

    To calculate and report the proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST criteria.

    Measured: 2 years

  4. 2-year disease-free survival (DFS) rate

    To measure and report the proportion of patients alive and free of disease recurrence, metastasis, or death within 2 years after radical resection.

    Measured: 3 years

  5. Overall survival (OS) rate

    To measure and report the proportion of patients alive at a defined time point, calculated from the date of enrollment to death from any cause.

    Measured: 5 years

  6. AE

    To monitor, record, and report adverse events (AEs), treatment-related adverse events (TRAEs), serious adverse events (SAEs), laboratory abnormalities, and treatment discontinuations due to toxicity.

    Measured: 2 years

Timeline

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

  1. First posted7 Apr 2026
  2. Study start30 May 2026 (estimated)
  3. Primary completion30 May 2028 (estimated)
  4. Study completion30 Oct 2030 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07515469
Sponsor's protocol ID
E20251317A
Status last verified
Mar 2026
First submitted
31 Mar 2026
Last updated
7 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iparomlimab and Tuvonralimab in people with HCC - Hepatocellular Carcinoma and Iparomlimab and Tuvonralimab Injection, run by Tianjin Medical University Cancer Institute and Hospital.

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 11 inclusion and 17 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: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Long Chun Zhang, doctor (+86 13011290101, asif@pku.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year disease-free survival rate (time frame: 2 years). 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 NCT07515469.

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 7 Apr 2026.

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