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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

NCT ID: NCT04667351

Last Updated: 2020-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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HepatoCellular Carcinoma

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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5-fu 2400

Group Type ACTIVE_COMPARATOR

2400 mg/m² 5-fu

Intervention Type DRUG

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

5-fu 1200

Group Type EXPERIMENTAL

1200 mg/m² 5-fu

Intervention Type DRUG

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

Interventions

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2400 mg/m² 5-fu

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

Intervention Type DRUG

1200 mg/m² 5-fu

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiping Central Hospital

OTHER

Sponsor Role collaborator

Guangzhou No.12 People's Hospital

OTHER_GOV

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Shi Ming

Proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Guangzhou Twelfth People 's Hospita

Guangzhou, Guangdong, China

Site Status RECRUITING

Kaiping Central Hospital

Kaiping, Guangdong, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Ming Shi, MD

Role: primary

Yuanmin Zhou, MD

Role: primary

Shijie Zhang, MD

Role: primary

Other Identifiers

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SH-1

Identifier Type: -

Identifier Source: org_study_id