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

Primary Purpose

HepatoCellular Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

5-Fu, oxaliplatin , leucovorin

About this trial

This is an interventional treatment trial for HepatoCellular Carcinoma focused on measuring Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, optimal dose

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Cancer Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Full Dosage

Low Dosage of 5-Fu

Low Dosage of oxaliplatin

Arm Description

Full Dosage Chemotherapy regimen administered by HAI

Low Dose of 5-Fu Chemotherapy regimen administered by HAI

Low Dose of oxaliplatin Chemotherapy regimen administered by HAI

Outcomes

Primary Outcome Measures

Tumor response

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

Secondary Outcome Measures

Adverse Events

Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Number of of Patients developed Adverse Events

Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.03

Full Information

NCT ID

NCT02987699

First Posted

December 7, 2016

Last Updated

December 27, 2016

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02987699

Brief Title

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

Official Title

Phase II Study of Hepatic Arterial Infusion Chemotherapy Using Oxaliplatin,Leucovorin and 5-Fluorouracil

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

April 2017 (Anticipated)

Study Completion Date

May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

The results of our preliminary pilot study suggested that the combination of oxaliplatin, leucovorin and 5-Fu introduced by hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to determine the recommended dose as well as the safety and efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HepatoCellular Carcinoma

Keywords

Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, optimal dose

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Full Dosage

Arm Type

Experimental

Arm Description

Full Dosage Chemotherapy regimen administered by HAI

Arm Title

Low Dosage of 5-Fu

Arm Type

Experimental

Arm Description

Low Dose of 5-Fu Chemotherapy regimen administered by HAI

Arm Title

Low Dosage of oxaliplatin

Arm Type

Experimental

Arm Description

Low Dose of oxaliplatin Chemotherapy regimen administered by HAI

Intervention Type

Drug

Intervention Name(s)

5-Fu, oxaliplatin , leucovorin

Other Intervention Name(s)

Full dose Folfox

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

5-Fu, oxaliplatin , leucovorin

Other Intervention Name(s)

Low dose 5-Fu Folfox

Intervention Description

Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 1400 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2

Intervention Type

Drug

Intervention Name(s)

5-Fu, oxaliplatin , leucovorin

Other Intervention Name(s)

Low dose oxaliplatin Folfox

Intervention Description

Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 85 mg/m2 (3) leucovorin: 400mg/m2

Primary Outcome Measure Information:

Title

Tumor response

Description

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

Time Frame

3 Months

Secondary Outcome Measure Information:

Title

Adverse Events

Description

Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03

Time Frame

30 days

Title

Number of of Patients developed Adverse Events

Description

Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.03

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Shi, Doctor

Phone

(8620)-87343938

shiming@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Shi, Doctor

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Shi, MD.

shiming@sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

shi Ming, MD.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

12049862

Citation

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.

Results Reference

result

PubMed Identifier

12540794

Citation

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.

Results Reference

result

Learn more about this trial

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

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