Phase II Study of HAIC Using Cisplatin,Leucovorin and 5-Fluorouracil

NCT02987699 | Unknown Phase 2 DMC

• 1 other identifier: Unique Protocol ID: HCC-S026
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase II study is to determine the recommended dose, as well as the safety and efficacy of the combination of oxaliplatin, leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) in patients with advanced hepatocellular carcinoma (HCC).

Conditions

HepatoCellular Carcinoma

Keywords

Hepatocellular Carcinoma; Hepatic arterial infusion chemotherapy; optimal dose

Outcome Measures

Primary Outcomes (1)

• Tumor response

  Tumor response evaluated by postoperative CT/MRI scan according to RECIST criteria.

  3 Months

Secondary Outcomes (2)

• Adverse Events

  30 days

• Number of of Patients developed Adverse Events

  30 days

Study Arms (3)

Full Dosage

EXPERIMENTAL

Full Dosage Chemotherapy regimen administered by HAI

Drug: 5-Fu, oxaliplatin , leucovorin

Low Dosage of 5-Fu

EXPERIMENTAL

Low Dose of 5-Fu Chemotherapy regimen administered by HAI

Drug: 5-Fu, oxaliplatin , leucovorin

Low Dosage of oxaliplatin

EXPERIMENTAL

Low Dose of oxaliplatin Chemotherapy regimen administered by HAI

Drug: 5-Fu, oxaliplatin , leucovorin

Interventions

5-Fu, oxaliplatin , leucovorin DRUG

Drug: 5-Fu, oxaliplatin and regular dose of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2

Also known as: Full dose Folfox

Full Dosage

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.
• diagnosed with major or main portal vein invasion (Vp3 or Vp4) KPS≥70； 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

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (2)

• Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.

  PMID: 12049862 RESULT

• Llovet JM, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival. Hepatology. 2003 Feb;37(2):429-42. doi: 10.1053/jhep.2003.50047.

  PMID: 12540794 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Fluorouracil; Oxaliplatin; 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)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Ming Shi, Doctor

  The Department of Hepatobiliary Pancreatic Oncology of Sun Yat-sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Shi, Doctor

CONTACT

(8620)-87343938; shiming@sysucc.org.cn

Study Design

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

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: December 28, 2016

Record last verified: 2016-12

Locations

CN (1)