Treatment of unresectable hepatocellular carcinoma with Ivonescimab and chemotherapy

A Single-arm, Single-center, Phase II Clinical Study of AK112 (a Dual-specific Antibody Against PD-1/VEGF) Combined With Hepatic Arterial Infusion Chemotherapy (HAIC) for the Treatment of Unresectable Hepatocellular Carcinoma.

This study is testing if a new treatment combining Ivonescimab and chemotherapy can help people with advanced liver cancer that can't be surgically removed.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06375486 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial aims to evaluate the safety and efficacy of Ivonescimab (AK112), a dual-specific antibody targeting PD-1 and VEGF, in combination with hepatic arterial infusion chemotherapy (HAIC) for patients with unresectable hepatocellular carcinoma (HCC). Approximately 30 patients with BCLC stage B or C HCC will be enrolled at a single center in China. Participants will receive AK112 alongside the FOLFOX chemotherapy regimen until they experience intolerable toxicity, show no further clinical benefit, or complete 24 months of treatment. Regular assessments will be conducted to monitor tumor response and overall health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable BCLC stage B or C hepatocellular carcinoma who have not received prior systemic therapy.

Not a fit: Patients with fibrolamellar hepatocellular carcinoma, cholangiocarcinoma, or those with Child-Pugh class B or C liver function will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with unresectable hepatocellular carcinoma, potentially improving survival and quality of life.

How similar studies have performed: While this approach is novel in its specific combination, similar studies using PD-1/VEGF inhibitors have shown promising results in other cancer types.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign a written informed consent form.
2. Age at enrollment is ≥ 18 years and ≤ 75 years, both males and females are eligible.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
4. Expected survival ≥ 3 months.
5. Confirmed histologically/cytologically or cirrhotic patients meeting the Barcelona Clinic Liver Cancer (BCLC) stage B or C criteria for hepatocellular carcinoma (HCC) according to the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria.
6. Not suitable for curative treatment (surgery or ablation) and have not previously received systemic anti-tumor therapy for unresectable HCC.
7. Liver function classified as Child-Pugh class A.
8. Sufficient organ function.

Exclusion Criteria:

1. Components including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, etc., confirmed histologically/cytologically.
2. Apart from HCC, subjects have had other malignant tumors within 5 years prior to enrollment. Subjects who have been cured of other malignant tumors through local treatment, such as basal or squamous cell carcinoma of the skin, superficial bladder cancer, cervical or breast carcinoma in situ, are not excluded. If diagnosed with liver cancer or other malignant tumors more than 5 years before dosing, pathological histology or cytology diagnosis of recurrent metastatic lesions is required.
3. Poor compliance, unable to cooperate and describe treatment responses.
4. History of past or current central nervous system (CNS) metastasis or leptomeningeal metastasis.
5. Presence of extrahepatic metastasis.
6. History of hepatic encephalopathy or liver transplantation.
7. Clinical symptoms or recurrent pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
8. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational devices within 4 weeks prior to the first dose.
9. History of or current non-infectious pneumonia or interstitial lung disease requiring systemic corticosteroid therapy.

Where this trial is running

Tianjin, Tianjin Municipality

• Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Huikai Li, MD

Conditions Hepatocellular Carcinoma Non-resectable; Hepatocellular Carcinoma