HAIC of Oxaliplatin, and 2400 mg/m² 5-fu vs HAIC of Oxaliplatin, and 1200 mg/m² 5-fu for Unresectable HCC: a Randomised Phase 3 Non-inferiority Trial

NCT04667351 | Unknown Phase 3 DMC

• 1 other identifier: SH-1
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

Hepatic artery infusion of oxaliplatin, leucovorin and 2400 mg/m² fluorouracil is effective in hepatocellular carcinoma. However, SILIUS study showed that sorafenib plus hepatic artery infusion of cisplatin and fluorouracil did not significantly improve overall survival compared with sorafenib alone. Whether fluorouracil is effevtive is known.

Conditions

HepatoCellular Carcinoma

Keywords

Hepatic arterial infusion chemotherapy; 2400 mg/m² 5-fu; 1200 mg/m² 5-fu

Outcome Measures

Primary Outcomes (1)

• overall survival

  24 months

Secondary Outcomes (4)

• progression-free survival

  24 months

• objective response rate

  6 months

• disease control rate

  6 months

• Adverse Events

  30 Days after HAIC

Study Arms (2)

5-fu 2400

ACTIVE COMPARATOR

Drug: 2400 mg/m² 5-fu

5-fu 1200

EXPERIMENTAL

Drug: 1200 mg/m² 5-fu

Interventions

2400 mg/m² 5-fu DRUG

Hepatic arterial infusion of oxaliplatin,leucovorin and 2400 mg/m² 5-FU

5-fu 2400

1200 mg/m² 5-fu DRUG

Hepatic arterial infusion of oxaliplatin,leucovorin and 1200 mg/m² 5-FU

5-fu 1200

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 18-75 years;
• KPS≥70;
• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
• Patients must have at least one tumor lesion that can be accurately measured;
• Diagnosed as unresectable with consensus by the panel of liver surgery experts;
• No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin
• ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine
• ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) \>1,500/mm3;
• Ability to understand the protocol and to agree to and sign a written informed consent document.

You may not qualify if:

• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Evidence of bleeding diathesis.
• Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Kaiping Central Hospital: collaborator
• Guangzhou No.12 People's Hospital: collaborator

Study Sites (3)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Guangzhou Twelfth People 's Hospita

Guangzhou, Guangdong, 510620, China

RECRUITING

Kaiping Central Hospital

Kaiping, Guangdong, 529300, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 14, 2020
• Study Start: March 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

CN (3)