Combining bTAE-HAIC with Lenvatinib and Sintilimab for Liver Cancer Treatment

Sequential bTAE-HAIC Combined With Lenvatinib and Sintilimab for Infiltrative Hepatocellular Carcinoma

This study is testing a new combination treatment of two medications and a special procedure to see if it can help people with advanced liver cancer feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Camrelizumab, Lenvatinib, chemotherapy, Sintilimab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06070636 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of a combination treatment involving blank-microsphere transcatheter arterial embolization with hepatic arterial infusion chemotherapy (bTAE-HAIC) alongside Lenvatinib and Sintilimab for patients diagnosed with infiltrative hepatocellular carcinoma (HCC). The approach aims to leverage the benefits of targeted therapy and immunotherapy in treating advanced liver cancer. The study is prospective and single-arm, focusing on patients with specific tumor characteristics and performance status. By assessing the outcomes of this novel combination, the study seeks to provide insights into a potentially effective treatment regimen for a challenging cancer type.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with infiltrative hepatocellular carcinoma characterized by specific imaging features and tumor size criteria.

Not a fit: Patients with encapsulated HCC or those with extensive extrahepatic metastasis are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with infiltrative hepatocellular carcinoma, potentially improving survival rates and quality of life.

How similar studies have performed: While this specific combination has not been previously evaluated, individual components have shown efficacy in treating hepatocellular carcinoma in other studies.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of infiltrative HCC.
2. Infiltrative HCC was characterized as follows: nonencapsulated arterial phase hyperenhancement; tumor washout in the period of portal phase, and noncircular, ill-defined margin
3. Age between 18 and 75 years;
4. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
5. Infiltrative HCC, with PVTT type I or type II or limited metastases (≤5).
6. Child-Pugh class A or B;
7. Eastern Cooperative Group performance status (ECOG) score of 0-2;
8. Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
9. Prothrombin time ≤18s or international normalized ratio \< 1.7.
10. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

1. HCC with capsule;
2. Extrahepatic metastasis \>5;
3. Obstructive PVTT involving the main portal vein.
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
6. Known history of HIV
7. History of organ allograft
8. Known or suspected allergy to the investigational agents or any agent given in association with this trial.
9. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
10. Evidence of bleeding diathesis.
11. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Qunfnag Zhou, MD

Conditions Liver Diseases; Hepatocellular Carcinoma; Immunotherapy; Lenvatinib; Sintilimab