Combining bTAE-HAIC with Lenvatinib and Camrelizumab for treating large liver cancer

Sequential bTAE-HAIC Combined With Lenvatinib and Camrelizumab for Intermediate-advanced Huge Hepatocellular Carcinoma

This study is testing a new treatment that combines different therapies to see if it can help people with large liver cancer feel better and improve their chances of recovery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: Camrelizumab, Lenvatinib, chemotherapy
• Locations: 1 site (Guanzhou, Guangdong)
• Trial ID: NCT06061276 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a treatment combining blank-microsphere transcatheter arterial embolization with hepatic arterial infusion chemotherapy (bTAE-HAIC) using oxaliplatin, 5-fluorouracil, and leucovorin, alongside Lenvatinib and Camrelizumab for patients with intermediate-advanced huge hepatocellular carcinoma (HCC). The approach aims to leverage the strengths of each treatment modality to improve outcomes for patients with large tumors. The study is prospective and single-arm, focusing on patients who meet specific clinical criteria related to tumor size and liver function.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with intermediate-advanced huge HCC and specific liver function criteria.

Not a fit: Patients with diffuse HCC, extrahepatic metastasis, or serious medical comorbidities may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with large hepatocellular carcinoma, potentially improving survival rates.

How similar studies have performed: While no studies have specifically evaluated the combination of bTAE-HAIC with Lenvatinib and Camrelizumab, individual components have shown efficacy in treating hepatocellular carcinoma.

Eligibility criteria

Inclusion Criteria:

1. Clinical diagnosis of HCC.
2. Age between 18 and 75 years;
3. The maximum tumor size ≥10 cm, and the total tumor size ≥15 cm;
4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I or type II or limited metastases (≤5).
5. Child-Pugh class A or B;
6. Eastern Cooperative Group performance status (ECOG) score of 0-2;
7. 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
8. Prothrombin time ≤18s or international normalized ratio \< 1.7.
9. Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

1. Diffuse HCC;
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

Guanzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guanzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Qunfnag Zhou, MD

Conditions: Liver Diseases, Hepatocellular Carcinoma, Immunotherapy, Camrelizumab, Lenvatinib