A Single-Arm, Multicenter, Exploratory Clinical Study of Transarterial Chemoembolization (TACE) Combined With Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection for the Treatment of Unresectable, Non-Metastatic Hepatocellular Carcinoma (HCC)

NCT07128251 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025KY309
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, multicenter, exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Iparomlimab and Tuvonralimab Injection and Bevacizumab Injection in patients with unresectable, non-metastatic HCC. The primary endpoint is PFS as assessed by the investigator based on RECIST v1.1 criteria.

Conditions

Hepatocellular Carcinoma (HCC); Immunotherapy; PD-1; CTLA-4; TACE

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) as assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

  Defined as the time from initiation of study intervention to the first occurrence of either investigator-assessed (RECIST v1.1) radiographic disease progression or death from any cause.

  2-year

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  6-month

• Disease Control Rate (DCR)

  6-month

• Overall Survival (OS)

  3-year

• Adverse event (AE)

  3-year

Study Arms (1)

experimental group

EXPERIMENTAL

TACE → Iparomlimab and Tuvonralimab Injection (QL1706) + Bevacizumab Injection (Q3W, 2 cycles). On-demand TACE therapy will be administered concurrently, with a maximum of 4 TACE sessions permitted.

Procedure: TACE treatment; Drug: Iparomlimab and Tuvonralimab Injection (QL1706); Drug: Bevacizumab

Interventions

TACE treatment PROCEDURE

TACE treatment (cTACE): On-demand TACE therapy will be administered, with a maximum of 4 TACE sessions permitted.

experimental group

Iparomlimab and Tuvonralimab Injection (QL1706) DRUG

Iparomlimab and Tuvonralimab Injection (QL1706): 7.5 mg/kg, intravenous infusion, Day 1 of each cycle, Q3W.

experimental group

Bevacizumab DRUG

Bevacizumab Injection: 15 mg/kg, intravenous infusion, Day 1 of each cycle, Q3W.

experimental 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:

• Voluntarily participate in the study and provide written informed consent.
• Age 18-75 years, inclusive (male or female).
• Histologically or cytologically confirmed HCC, or clinically diagnosed HCC according to the \*Clinical Practice Guidelines for Primary Liver Cancer (2024 Edition)\*.
• Barcelona Clinic Liver Cancer (BCLC) Stage A, B, or C, not amenable to curative treatment (e.g., surgical resection, liver transplantation, or ablation).
• At least one measurable lesion according to RECIST v1.1 criteria.
• Suitable candidate for Transarterial Chemoembolization (TACE) with no known allergy or contraindication to iodized oil or epirubicin.
• Child-Pugh Liver Function Class A.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Life expectancy ≥ 3 months.
• Adequate organ and bone marrow function.
• If positive for Hepatitis B Virus (HBV) infection, HBV DNA must be \< 2000 IU/mL (\< 10,000 copies/mL if only copies/mL units available at the site) and the subject must be willing to receive continuous antiviral therapy throughout the study period. Subjects positive for Hepatitis C Virus (HCV) RNA must receive antiviral therapy according to clinical guidelines.
• Subjects with esophageal/gastric varices must undergo evaluation and appropriate management prior to enrollment.
• Women of childbearing potential (WOCBP): Must have a negative serum human chorionic gonadotropin (hCG) test within 7 days prior to initiation of study treatment; must be non-lactating; must agree to use highly effective contraception methods from signing informed consent until 120 days after the last dose of study treatment. A woman is considered of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (hysterectomy, bilateral salpingectomy/oophorectomy). Male subjects with female partners of childbearing potential: Must agree to use highly effective contraception methods from signing informed consent until 120 days after the last dose of study treatment; must agree to refrain from sperm donation. Male subjects with pregnant partners must use condoms; no additional contraception is required.

You may not qualify if:

• Known fibrolamellar HCC, sarcomatoid HCC, mixed hepatocellular cholangiocarcinoma, or cholangiocarcinoma; history of other active malignancies within 5 years or concurrently with HCC. Cured localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder carcinoma, carcinoma \*in situ\* of the prostate, cervix, or breast) are permitted.
• Presence of Vp3 or Vp4 portal vein tumor thrombosis (PVTT), any grade of hepatic vein or inferior vena cava invasion; any grade of bile duct invasion. \*Note: Vp1 or Vp2 PVTT is permitted.\*
• Presence of extrahepatic spread (EHS).
• Intrahepatic lesion(s) with maximum diameter ≥ 10 cm, \> 10 intrahepatic lesions, or intrahepatic tumor burden ≥ 70% of liver volume, per RECIST v1.1.
• Prior systemic anti-cancer therapy for HCC, including molecular targeted agents, cytotoxic chemotherapy, immunotherapy (e.g., immune checkpoint inhibitors, immune checkpoint agonists, cellular therapies), or biologic therapy (e.g., cancer vaccines, cytokines, growth factors).
• Prior locoregional therapy for HCC, including therapeutic TACE, transarterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC), transarterial radioembolization (TARE).
• \) Prior curative surgery or ablation is permitted; one session of prophylactic TACE following curative resection is permitted.
• \) Prior percutaneous ethanol injection (PEI) or radiotherapy with curative intent is permitted.
• \. Prior or planned organ transplantation or allogeneic bone marrow transplantation.
• \. Current interstitial lung disease (ILD)/pneumonitis, history of ILD/pneumonitis requiring steroid treatment, or other pulmonary conditions that may interfere with the detection or management of immune-mediated pneumonitis (e.g., pulmonary fibrosis, organizing pneumonia \[e.g., bronchiolitis obliterans\], pneumoconiosis, drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonia evidenced by screening chest computed tomography \[CT\] scan). Prior radiation pneumonitis within the radiation field is permitted. Active tuberculosis.
• \. Active autoimmune disease or history of autoimmune disease with potential for recurrence (e.g., autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; subjects with hypothyroidism stable on hormone replacement are eligible). Conditions not requiring systemic therapy (e.g., vitiligo, psoriasis, alopecia), controlled Type I diabetes on insulin, or childhood asthma in complete remission without adult intervention are permitted. Asthma requiring bronchodilator therapy is excluded.
• \. Clinically significant ascites requiring therapeutic paracentesis or drainage (Child-Pugh score \>2 for ascites; asymptomatic ascites detected only radiographically is permitted); uncontrolled or moderate/large pleural effusion or pericardial effusion.
• \. Uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg based on ≥2 measurements) despite antihypertensive therapy; history of hypertensive crisis or hypertensive encephalopathy.
• \. Clinically significant cardiac disease. 13. History of spontaneous rupture of hepatic tumor(s). 14. History of hepatic encephalopathy. 15. History or presence of central nervous system metastases. 16. Congenital or acquired immunodeficiency (e.g., HIV infection). 17. Thromboembolic event within 3 months prior to treatment (e.g., cerebrovascular accident \[including transient ischemic attack, cerebral hemorrhage, cerebral infarction\], deep vein thrombosis, pulmonary embolism).
• \. Major surgical procedure within 4 weeks prior to treatment or anticipated during study; unhealed wound, ulcer, or fracture within 4 weeks prior to treatment.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• Qilu Hospital of Shandong University: collaborator
• Henan Provincial People's Hospital: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Shanxi Provincial Cancer Hospital: collaborator
• Xi'an International Medical Center Hospital: collaborator
• The Second Affiliated Hospital of Harbin Medical University: collaborator

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Diabetes Mellitus, Insulin-Dependent, 12

Interventions

Bevacizumab

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Lianxin Liu

CONTACT

0551-62283477; liulx@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 17, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): December 30, 2029
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share