Combining dTACE-HAIC with Bevacizumab and Atezolizumab for treating large liver cancer

dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Intermediate and Advanced Hepatocellular Carcinoma: a Prospective Phase II Study

This study is testing a new combination treatment for people with large liver cancer to see if it works better than current options for those who can't have surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Bevacizumab, Atezolizumab, chemotherapy
• Locations: 1 site (Beijing, None Selected)
• Trial ID: NCT06609863 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of a combination treatment involving drug-eluting transcatheter arterial embolization and hepatic arterial infusion chemotherapy (dTACE-HAIC) with Bevacizumab and Atezolizumab for patients suffering from intermediate-advanced huge hepatocellular carcinoma. The approach aims to provide a locoregional therapy option for patients who are not candidates for radical therapy. The study will assess how well this combination improves patient outcomes compared to existing treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a clinical diagnosis of hepatocellular carcinoma and a tumor size of 10 cm or greater.

Not a fit: Patients with diffuse hepatocellular carcinoma or those with extensive extrahepatic metastasis may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with large hepatocellular carcinoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of therapies for advanced hepatocellular carcinoma, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Clinical diagnosis of HCC.
2. Age between 18 and 75 years;
3. The maximum tumor size ≥10 cm;
4. Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
5. limited metastases (≤5).
6. Child-Pugh class A or B;
7. Eastern Cooperative Group performance status (ECOG) score of 0-1;
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. Diffuse HCC;
2. Extrahepatic metastasis \>5;
3. Obstructive PVTT involving mesenteric vena cava (PVTT IV).
4. Serious medical comorbidities.
5. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
6. untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.
7. Eastern Cooperative Group performance status (ECOG) score of ≥2;
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

Beijing, None Selected

• Chinese PLA General hospital — Beijing, None Selected, China (Recruiting)

Study contacts

• Principal investigator: Feng Duan, MD — Chinese PLA General Hospital
• Study coordinator: Qunfang Zhou, MD

Conditions Advanced Hepatocellular Carcinoma; Atezolizumab; Bevacizumab; Chemotherapy; hepatocellular carcinoma