HAIC Compared With TACE in Huge Hepatocellular Carcinoma

NCT06641713 | Recruiting

• 1 other identifier: Liver Projiect 13
• Study Type: observational
• Target: 664
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Hepatic Chemotherapy; Liver Cancer

Keywords

Advanced hepatocellular carcinoma; TACE; HAIC; system therapy

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  ORR, as determined based on tumor response according to mRECIST, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.

  6 months

Secondary Outcomes (2)

• Progression-Free-Survival

  12 months

• Overall survival

  24 months

Study Arms (2)

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.

Procedure: TACE

HAIC

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

Procedure: HAIC

Interventions

TACE 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.

TACE

HAIC 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

HAIC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study is a multicenter, observational real-world study to compare the efficacy of HAIC with TACE in advancedhuge hepatocellular carcinoma. This study focused on the management of locoregional therapy . This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC and TACE in huge HCC therapy.

You may qualify if:

• Clinical diagnosis of primary HCC.
• Age between 18 and 75 years;
• The maximum tumor size ≥10 cm;
• Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
• limited metastases (≤5).
• Child-Pugh class A or B;
• Eastern Cooperative Group performance status (ECOG) score of 0-1;
• 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
• Prothrombin time ≤18s or international normalized ratio \< 1.7.

You may not qualify if:

• recurrent HCC;
• Extrahepatic metastasis \>5;
• Obstructive PVTT involving mesenteric vena cava (PVTT IV).
• Serious medical comorbidities.
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Eastern Cooperative Group performance status (ECOG) score of ≥2;
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Feng Duan, MD

  Chinese PLA General Hospital

  STUDY DIRECTOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.com

Feng Duan, MD

CONTACT

86 13910984586; duanfeng@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 12, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

CN (1)