Phase 2 Study of Sorafenib Plus HAIC of FOLFOX vs. Sorafenib Plus HAIC of OXA for Advanced HCC

NCT03812770 | Unknown Phase 2 DMC

• 1 other identifier: HCC-OXA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with advanced hepatocellular carcinoma (HCC)

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Sorafenib; Hepatic artery infusion chemotherapy; Oxaliplatin, 5-Fluorouracil and Leucovorin; Oxaliplatin

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.

  12 months

Secondary Outcomes (3)

• Overall Survival (OS)

  12 months

• Objective Response Rate (ORR)

  12 months

• Adverse Events

  30 days

Study Arms (2)

Sorafenib plus HAIC of OXA

EXPERIMENTAL

Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin

Drug: Sorafenib; Drug: HAIC of OXA

Sorafenib plus HAIC of FOLFOX

ACTIVE COMPARATOR

Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin, Fluorouracil and Leucovorin

Drug: Sorafenib; Drug: HAIC of FOLFOX

Interventions

Sorafenib DRUG

Oral Sorafenib, 400mg, Bid

Sorafenib plus HAIC of FOLFOX; Sorafenib plus HAIC of OXA

HAIC of FOLFOX DRUG

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

Also known as: Oxaliplatin , fluorouracil, and leucovorin

Sorafenib plus HAIC of FOLFOX

HAIC of OXA DRUG

administration of Oxaliplatin via the tumor feeding arteries

Also known as: Oxaliplatin

Sorafenib plus HAIC of OXA

Eligibility Criteria

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

You may qualify if:

• 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 according to EASL criteria.
• Barcelona clinic liver cancer-stage C
• Eastern Cooperative Oncology Group performance status of 0 to 2
• with no previous treatment
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
• The following laboratory parameters:
• Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 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
• Ability to understand the protocol and to agree to and sign a written informed consent document

You may not qualify if:

• 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.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
• Serious non-healing wound, ulcer, or bone fracture
• Known central nervous system tumors including metastatic brain disease

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

Interventions

Sorafenib; Oxaliplatin; Fluorouracil; Leucovorin

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Uracil; Pyrimidinones; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 23, 2019
• Study Start: August 4, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-01

Locations

CN (3)