HAIC Compared With TACE in Huge Hepatocellular Carcinoma

NCT ID: NCT06641713

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 664 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-12-30

Brief Summary

This study intends to compare the efficacy of transcatheter arterial chemical embolization (TACE) with hepatic arterial infusion chemotherapy (HAIC) for patients with intermediate-advanced huge hepatocellular carcinoma.

Detailed Description

Transcatheter arterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) are effective and safe for hepatocellular carcinoma (HCC). For huge HCC (≥10 cm), the prognosis of this high tumor-burden subtype usually indicates poor outcome and big challenge. TACE is difficult to completely embolize all tumor arteries, so patients have limited benefit from pure hepatic artery embolization. At the same time, excessive embolization will lead to massive tumor necrosis in a short time, and inflammatory necrosis factor will enter the blood, resulting in systemic inflammatory response. HAIC have showed good efficacy especially for advanced huge HCC (≥10 cm) complicated with portal vein tumor thrombus and arteriovenous fistula, and HAIC therapy can be performed with better and higher tumor control.

Conditions

Hepatocellular Carcinoma; Hepatic Chemotherapy; Liver Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

TACE

TACE procedure was a 2.8-F microcatheter was super-selectively inserted into the tumor feeding artery using the coaxial technique. Then conventional TACE or drug-eluting TACE was used.

TACE

Intervention Type: PROCEDURE

TACE was carried out under the guidance of digital subtraction angiography, and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The emulsion of the selected drug and the embolization agents was therefore injected infused into tumor-feeding arteries via the selective microcatheter. A final arteriography confirmed the success of the procedure. The endpoint of the TACE procedure was reached when there was no flow in the tumor-feeding vessels.

HAIC

HIAC was conducted with hepatic arterial infusion of oxaliplatin, fluorouracil, and leucovorin every 3-4 weeks.

HAIC

Intervention Type: PROCEDURE

HAIC was carried out under the guidance of digital subtraction angiography, 990and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks

Interventions

TACE

TACE was carried out under the guidance of digital subtraction angiography, and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The emulsion of the selected drug and the embolization agents was therefore injected infused into tumor-feeding arteries via the selective microcatheter. A final arteriography confirmed the success of the procedure. The endpoint of the TACE procedure was reached when there was no flow in the tumor-feeding vessels.

Intervention Type: PROCEDURE

HAIC

HAIC was carried out under the guidance of digital subtraction angiography, 990and hepatic artery angiography was used to assess the location, number, size, and blood supply of the targeted tumor. Then a more selective microcatheter was used to vascularize the tumor. The FOLFOX regimen was administered via the hepatic artery as follows: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1, and 400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2. Hepatic arterial infusion chemotherapy administration of oxaliplatin, fluorouracil, and leucovorin via the tumor feeding arteries every 4 weeks

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Clinical diagnosis of primary 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.

Exclusion Criteria

1. recurrent 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. Eastern Cooperative Group performance status (ECOG) score of ≥2;

7. Known or suspected allergy to the investigational agents or any agent given in association with this trial.

8. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhou Qunfang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Duan, MD

Role: STUDY_DIRECTOR

Chinese PLA General Hospital

Locations

Chinese PLA general hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qunfang Zhou, MD

Role: CONTACT

zhouqun988509@163.com

86 19868000115

Feng Duan, MD

Role: CONTACT

duanfeng@vip.sina.com

86 13910984586

Facility Contacts

Qunfang Zhou, MD

Role: primary

zhouqun988509@163.com

8619868000115

Feng Duan, MD

Role: backup

duanfeng@vip.sina.com

8613910984586

Other Identifiers

Liver Projiect 13

Identifier Type: -

Identifier Source: org_study_id