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A Prospective, Single-arm Clinical Study to Evaluate the Efficacy and Safety of Epaloritovorilil Monoclonal Antibody Combined with Lenvatinib as Second-line Treatment in Patients with Advanced Hepatocellular Carcinoma

A Prospective, Single-arm Clinical Study to Evaluate the Efficacy and Safety of Epaloritovorilil Monoclonal Antibody Combined with Lenvatinib as Second-line Treatment in Patients with Advanced Hepatocellular Carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113629
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Treatment Group:Immunotherapy combined with targeted therapy

Sponsors

The Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: Age between 18 and 75 years, male or female; 2: Radiological and/or pathological diagnosis consistent with the diagnostic criteria for hepatocellular carcinoma (HCC) according to the Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 edition); 3: Patients who have previously received systemic antitumor therapy for HCC (such as anti–PD-1/PD-L1 antibody, T+T, or A+T regimen) and experienced disease progression or intolerance; 4: Child–Pugh score =12 weeks; 8: Signed informed consent and ability to comply with the study protocol and follow-up schedule.

Exclusion criteria

Exclusion criteria: 1: Known hypersensitivity or allergy to study drugs; 2: Known diagnosis of cholangiocarcinoma (ICC), mixed-type hepatocellular carcinoma, hepatoblastoma, or fibrolamellar carcinoma; 3: Known brain metastases; 4: History of other malignancies within the past 5 years that have not been cured or may interfere with study evaluation; 5: Presence of any unresolved >= Grade 2 adverse event (CTCAE) related to prior antitumor therapy; 6: History of immunodeficiency, current use of immunosuppressive agents, or active autoimmune disease; 7: Concurrent severe cardiovascular, heart failure, respiratory disease, or serious acute/chronic infection requiring antiviral treatment (excluding viral hepatitis); 8: Prior treatment with lenvatinib-containing regimens and/or Epaloritovorilil monoclonal antibody plus lenvatinib; 9: Pregnant or breastfeeding women, or women planning pregnancy during the study period; 10: Patients with infectious diseases or other conditions deemed by the investigator to be unable to comply with study treatment and follow-up.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate (ORR);Disease Control Rate (DCR);Progression-Free Survival (PFS);Overall Survival (OS);Safety;

Countries

China

Contacts

Public ContactJianbing Wu

The Second Affiliated Hospital of Nanchang University

hhgwjb@163.com+86 135 0791 7177

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026