Sorafenib or Lenvatinib Plus HAIC of 130 mg/m² Oxaliplati... | NCT04687163

Studies
Sorafenib or Lenvatinib Plus HAIC of 130 mg/m² Oxaliplatin, and 5-fu vs Sorafenib or Lenvatinib Plus HAIC of 85mg/m² Oxaliplatin, and 5-fu for Unresectable Advanced HCC: a Randomised Phase 3 Trial

NCT04687163

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

Jan 13, 2021Actual

Enrollment

400Estimated

Phase

Phase 3

Conditions

Hepatocellular Carcinoma

Interventions

HAIC of 130 mg/m² Oxaliplatin, and 5-fu
HAIC of 85 mg/m² Oxaliplatin, and 5-fu
TKI

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2020Actual

Primary Completion Date

Dec 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Dec 24, 2020

First Submission Date that Met QC Criteria

Dec 24, 2020

First Posted Date

Dec 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2021

Last Update Posted Date

Jan 13, 2021Actual

Name	Class
Kaiping Central Hospital	OTHER
Guangzhou No.12 People's Hospital	OTHER_GOV

Description Module

Brief Summary

A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. However, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. It is unknown which oxaliplatin dose is better.

Detailed Description

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OXA 130	Experimental	Patients received sorafenib or lenvatinib Plus HAIC of 130 mg/m² oxaliplatin, and 2400 mg/m² 5-fu	Drug: HAIC of 130 mg/m² Oxaliplatin, and 5-fu Drug: TKI
OXA 85	Active Comparator	Patients received sorafenib or lenvatinib Plus HAIC of 85 mg/m² oxaliplatin, and 2400 mg/m² 5-fu	Drug: HAIC of 85 mg/m² Oxaliplatin, and 5-fu Drug: TKI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HAIC of 130 mg/m² Oxaliplatin, and 5-fu	Drug	Hepatic arterial infusion of 130 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU	OXA 130

Measure	Description	Time Frame
Overall survival		24 months

Measure	Description	Time Frame
progression-free survival		24 months
objective response rate		6 months
time to response

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;
With vascular invasion or extrahepatic metastasis
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008113	Liver Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases

ID	Term
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds