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Resectable Hepatocellular Carcinoma With High Risk of RecurrencePhase 2CCGLC-017NCT06954116

Iparomlimab and Tuvonralimab as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With High Risk of Recurrence

A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706) and Partial hepatectomy in people with Resectable Hepatocellular Carcinoma With High Risk of Recurrence, run by Tongji 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
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Trial summary

The purpose of this study is to evaluate the impact of iparomlimab and tuvonralimab as preoperative neoadjuvant therapy on recurrence-free survival (RFS), along with its potential improvement in overall survival (OS), in patients with resectable hepatocellular carcinoma (HCC) at high risk of recurrence. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Iparomlimab and Tuvonralimab (QL1706) and Partial hepatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteChina
Study dates
1 Aug 2025to 1 Apr 2029
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

  • Hepatocellular carcinoma is proven on biopsy or confirmed by the presence of radiological hallmarks, according to the American Association for the Study of Liver Diseases or European Association for the Study of the Liver guidelines.
  • Aged 18 to 75 years.
  • BCLC A/B, or BCLC C without extrahepatic metastasis.
  • Suitable for radical surgery after evaluation by the hepatobiliary tumor MDT expert group.
  • No distant metastasis confirmed by CT or MRI.
  • No prior systemic anti-tumor treatment for hepatocellular carcinoma before the first dose.
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  • ECOG ≤ 2.
  • Child-Pugh ≤ 7.
  • Adequate organ and bone marrow function, with laboratory test values meeting the following requirements within 7 days prior to inclusion (no blood components, cell growth factors, albumin, or other intravenous or subcutaneous corrective treatment drugs are allowed within 14 days prior to obtaining laboratory tests):
  • Complete blood count: Absolute Neutrophil Count (ANC) ≥1.5×10^9/L; Platelet count (PLT) ≥75×10^9/L; Hemoglobin (HGB) ≥9.0 g/dL.
  • Liver function: Total Bilirubin (TBIL) ≤2×Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤5×ULN; Serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN.
  • Kidney function: Serum Creatinine (Cr) ≤ 1.5×ULN or Clearance of Creatinine (CCr) ≥50mL/min (Cockcroft-Gault formula); Urinalysis shows proteinuria <2+; For subjects with baseline urinalysis showing proteinuria ≥2+, a 24-hour urine collection should be performed and 24-hour urinary protein quantification <1g.
  • Coagulation function: International Normalized Ratio (INR) ≤2.3 or Prothrombin Time (PT) extension ≤6 seconds.
  • Meet the criteria for resectable HCC with High Risk of Recurrence:
  • Multiple (≥2) tumors.
  • Segmental portal vein invasion (Vp1/Vp2).
  • CT/MRI imaging: gross classification: type II, III, IV.
  • Estimated life expectancy of ≥12 weeks.
  • Female subjects of childbearing age or male subjects whose sexual partners are of childbearing age need to take effective contraceptive measures during the entire treatment period and for 6 months after the last medication.
  • Signed written informed consent, and able to comply with the visit and related procedures stipulated in the protocol.

Who cannot join

  • Histologically/cytologically confirmed fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc.
  • History of hepatic encephalopathy or liver transplantation.
  • Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage. Subjects with only radiologically detected minimal pleural effusion, ascites, or pericardial effusion without symptoms can be enrolled.
  • Acute or chronic active hepatitis B or C infection, with hepatitis B virus (HBV) DNA >2000IU/ml or 10^4 copies/ml; hepatitis C virus (HCV) RNA >10^3 copies/ml; co-positive for hepatitis B surface antigen (HbsAg) and anti-HCV antibody. Subjects who meet the above criteria after antiviral treatment with nucleoside analogs can be enrolled.
  • History of esophageal or gastric variceal bleeding due to portal hypertension within the past 6 months. Subjects assessed by the investigator to be at high risk of bleeding.
  • Any life-threatening bleeding event within the past 3 months, including those requiring blood transfusion, surgery or local treatment, or continuous drug treatment.
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  • History or current diagnosis of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severe impairment of lung function, and other lung diseases.
  • Active pulmonary tuberculosis, currently receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year prior to the first dose.
  • Active autoimmune disease requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.) is allowed. History of primary immunodeficiency. Patients with only autoantibody positivity need to be confirmed by the investigator whether there is an autoimmune disease.
  • History of arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other serious thromboembolic events. Exceptions are made for thrombosis formation related to implanted venous infusion ports or catheters, or superficial vein thrombosis that has stabilized after routine anticoagulation treatment. Preventive use of low-dose low molecular weight heparin (such as enoxaparin 40 mg/day) is allowed.
  • Continuous use of aspirin (>325 mg/day) or other known platelet function inhibitors such as clopidogrel or ticlopidine for 10 days within 2 weeks prior to the first dose.
  • Uncontrolled hypertension, with systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100mmHg after optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
  • Major surgery (craniotomy, thoracotomy, or laparotomy) or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose. Minor surgical procedures or tissue biopsy within 7 days prior to the first dose, excluding venous puncture for the purpose of intravenous infusion, are excluded.
  • Uncontrolled/uncorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and/or uncertainty in survival evaluation, or other conditions judged by the investigator to be unsuitable for enrollment.
  • History of gastrointestinal perforation and/or fistula within the previous 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea.

Trial locations and contacts

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

Ze-yang Ding, M.D. contact

+8613407156200

zyding@tjh.tjmu.edu.cn

Han Gao contact

+8617730117747

gh1023606887@163.com

China1 site, 1 recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Ze-yang Ding, M.D., +8613407156200, zyding@tjh.tjmu.edu.cn

    Han Gao, +8617730117747, gh1023606887@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Open-Label, Single-Arm, Exploratory Clinical Study on the Anti-Recurrence Effect of Neoadjuvant Iparomlimab and Tuvonralimab in Resectable Hepatocellular Carcinoma With High Risk of Recurrence After Radical Resection

The purpose of this study is to evaluate the impact of iparomlimab and tuvonralimab as preoperative neoadjuvant therapy on recurrence-free survival (RFS), along with its potential improvement in overall survival (OS), in patients with resectable hepatocellular carcinoma (HCC) at high risk of recurrence.

Read the detailed description

CCGLC-017 is a prospective, open-label, single-arm, exploratory clinical study. This study primarily evaluates the impact of iparomlimab and tuvonralimab (QL1706) as preoperative neoadjuvant therapy on recurrence-free survival (RFS), with exploratory analysis of its potential benefits on overall survival (OS) in patients with resectable hepatocellular carcinoma (HCC) at high risk of recurrence. Enrolled patients will receive a single dose of iparomlimab and tuvonralimab within one week prior to surgery, followed by six cycles of iparomlimab and tuvonralimab therapy postoperatively.

Being tested
Iparomlimab and Tuvonralimab (QL1706), Partial hepatectomy
Keywords
Hepatocellular Carcinoma, Neoadjuvant Therapy, Iparomlimab and Tuvonralimab, Immunotherapy, Anti-recurrence
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 Tuvonralimab (QL1706)Drug

    Neoadjuvant phase: A single cycle of Iparomlimab and Tuvonralimab (7.5 mg/kg) will be administered within 1 week prior to surgery.

    Adjuvant phase: Six cycles of Iparomlimab and Tuvonralimab (7.5 mg/kg, Q3W) will be initiated starting at 2 weeks postoperatively.

  • Partial hepatectomyProcedure or surgery

    Will be performed at an appropriate interval following neoadjuvant therapy initiation.

Study groups in NCT06954116
Study groupRoleWhat they receive
Experimental: Iparomlimab and TuvonralimabExperimentalPatients will receive a single preoperative dose of Iparomlimab and Tuvonralimab (7.5 mg/kg) within one week prior to surgery. Partial hepatectomy will be performed at an appropriate interval following neoadjuvant therapy initiation. From the second week postoperatively, adjuvant therapy with six cycles of Iparomlimab and Tuvonralimab (7.5 mg/kg, Q3W) will be administered.
Receives: Drug: Iparomlimab and Tuvonralimab (QL1706); Procedure: Partial hepatectomy

What is being measured

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

  1. Recurrence-Free Survival (RFS)

    The duration will be calculated from the date of achieving complete response (CR) after surgery to the first documented occurrence of intrahepatic or extrahepatic HCC recurrence, or death from any cause, whichever comes first.

    Measured: From the date of achieving complete response (CR) after surgery until the date of first documented recurrence or death from any cause, assessed up to 24 months post-surgery.

Secondary outcomes (10)

  1. Overall Survival (OS)

    Overall survival (OS): measured from date of first treatment to the date of death from any cause. Participants alive or lost to follow-up will be censored at the date of their last visit.

    Measured: from the date of first treatment to the date of death from any cause, assessed up to 5 years

  2. Major Pathological Response (MPR)

    Defined as the presence of ≤50% residual viable tumor cells in the resected specimen confirmed by postoperative pathological examination.

    Measured: Intraoperative frozen section assessment and final postoperative pathology (assessed within 4 weeks after surgery).

  3. Investigator-Assessed Recurrence-Free Survival (RFS)

    Defined as the time from treatment initiation to the first documented intrahepatic or extrahepatic HCC recurrence, or death from any cause (whichever occurs first), as determined by the investigator.

    Measured: From treatment initiation until the date of first documented HCC recurrence or death from any cause, whichever occurs first, assessed up to 24 months.

  4. Time to Recurrence (TTR)

    Defined as the time from treatment initiation to the first documented intrahepatic or extrahepatic HCC recurrence event.

    Measured: From treatment initiation until the date of first documented HCC recurrence, assessed up to 24 months.

  5. IRF-Assessed RFS Rate at 12 and 24 Months

    Defined as the proportion of patients without documented intrahepatic/extrahepatic HCC recurrence or death from any cause at 12 and 24 months post-treatment, assessed by an independent review facility (IRF) using standardized imaging criteria (RECIST 1.1/mRECIST).

    Measured: At 12 and 24 months post-treatment.

  6. Investigator-Assessed RFS Rate at 12 and 24 Months

    Defined as the proportion of patients without documented intrahepatic/extrahepatic HCC recurrence or death from any cause at 12 and 24 months post-treatment, as assessed by the investigator.

    Measured: At 12 and 24 months post-treatment

  7. OS Rate at 12 and 24 Months

    Defined as the proportion of patients surviving at 12 and 24 months post-treatment initiation.

    Measured: At 12 and 24 months post-treatment initiation.

  8. Time to Extrahepatic Spread (EHS) or Macrovascular Invasion

    Defined as the time from treatment initiation to the first radiologically or histologically confirmed occurrence of either extrahepatic metastasis or macrovascular invasion (portal/hepatic vein involvement).

    Measured: From treatment initiation until the date of first documented EHS or macrovascular invasion, assessed up to 24 months.

  9. RFS in PD-L1-High Subgroup or macrovascular invasion (portal/hepatic vein involvement).

    Defined as recurrence-free survival in patients with PD-L1-high expression (predefined as combined positive score [CPS] ≥1 by immunohistochemistry) assessed by both investigator and IRF.

    Measured: From the date of achieving complete response (CR) after surgery until the date of first documented HCC recurrence or death from any cause, whichever comes first, assessed up to 24 months post-surgery.

  10. Incidence of Adverse Events (AEs)

    Defined as the proportion of participants experiencing adverse events, graded per Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: From the first dose of iparomlimab/tuvonralimab administration until 90 days after the last dose of adjuvant therapy (up to approximately 34 weeks).

Timeline

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

  1. First posted1 May 2025
  2. Study start1 Aug 2025
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion1 Apr 2029 (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
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06954116
Sponsor's protocol ID
TJ-IRB202503089
Acronym
CCGLC-017
Status last verified
Sep 2026
First submitted
9 Apr 2025
Last updated
18 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Iparomlimab and Tuvonralimab (QL1706) and Partial hepatectomy in people with Resectable Hepatocellular Carcinoma With High Risk of Recurrence, run by Tongji 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 20 inclusion and 15 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 18 Sep 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 Ze-yang Ding, M.D. (+8613407156200, zyding@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-Free Survival (RFS) (time frame: From the date of achieving complete response (CR) after surgery until the date of first documented recurrence or death from any cause, assessed up to 24 months post-surgery.). 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 NCT06954116.

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 18 Sep 2026.

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