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

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Sorafenib

HAIC of FOLFOX

HAIC of OXA

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Sorafenib, Hepatic artery infusion chemotherapy, Oxaliplatin, 5-Fluorouracil and Leucovorin, Oxaliplatin

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.
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

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
Guangzhou Twelfth People 's HospitaRecruiting
Kaiping Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sorafenib plus HAIC of OXA

Sorafenib plus HAIC of FOLFOX

Arm Description

Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival (OS)

OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

Objective Response Rate (ORR)

ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.

Adverse Events

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

Full Information

NCT ID

NCT03812770

First Posted

January 19, 2019

Last Updated

April 15, 2019

Sponsor

Sun Yat-sen University

Collaborators

Kaiping Central Hospital, Guangzhou No.12 People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03812770

Brief Title

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

Official Title

Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin for Advanced Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 4, 2018 (Actual)

Primary Completion Date

September 1, 2019 (Anticipated)

Study Completion Date

September 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

Kaiping Central Hospital, Guangzhou No.12 People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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)

Detailed Description

Sorafenib is the most widely used palliative treatment for advanced hepatocellular carcinoma (HCC) patients . Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to advanced HCC . However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.

6. Conditions and Keywords

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

Hepatocellular Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sorafenib plus HAIC of OXA

Arm Type

Experimental

Arm Description

Sorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin

Arm Title

Sorafenib plus HAIC of FOLFOX

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Intervention Description

Oral Sorafenib, 400mg, Bid

Intervention Type

Drug

Intervention Name(s)

HAIC of FOLFOX

Other Intervention Name(s)

Oxaliplatin , fluorouracil, and leucovorin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

HAIC of OXA

Other Intervention Name(s)

Oxaliplatin

Intervention Description

administration of Oxaliplatin via the tumor feeding arteries

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

12 months

Title

Objective Response Rate (ORR)

Description

Time Frame

12 months

Title

Adverse Events

Description

Number of adverse events. 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. 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 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

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

Phone

86-2087343154

Ext

86-2087343154

shiming@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Ping Rong, Guo

Phone

86-2087342266

Ext

86-2087342266

guorongp@mail.sysu.edu.cn

First Name & Middle Initial & Last Name & Degree

Ming Shi

Facility Name

Guangzhou Twelfth People 's Hospita

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510620

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yuanmin Zhou, MD

Phone

15521278919

13430288977@139.com

First Name & Middle Initial & Last Name & Degree

Jinghua Chen, MD

Facility Name

Kaiping Central Hospital

City

Kaiping

State/Province

Guangdong

ZIP/Postal Code

529300

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

WanQiang Fang, MD

Phone

13717287622

fangwanqiang1970@sina.com

12. IPD Sharing Statement

Learn more about this trial

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

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