the Effect of Different Oxaliplatin Dose in Transarterial Infusion (TAI) in Unresectable Hepatocellular Carcinoma

NCT03777475 | Unknown DMC

• 1 other identifier: B2017-005-01
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

evaluate the effect of different oxaliplatin dose in TAI in treating unresectable HCC.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• OS

  overall survival

  From date of randomization until the date of death from any cause, assessed up to 60 months

Secondary Outcomes (2)

• ORR

  From date of randomization until the date of death from any cause, assessed up to 60 months

• PFS

  From date of randomization until the date of progress from any cause, assessed up to 60 months

Study Arms (2)

low dose

EXPERIMENTAL

low oxaliplatin (85mg/m2)

Procedure: transarterial infusion

high dose

ACTIVE COMPARATOR

high oxaliplatin (135mg/m2)

Procedure: transarterial infusion

Interventions

transarterial infusion PROCEDURE

transarterial infusion

high dose; low dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years old and younger than 75 years;
• ECOG PS≤1;
• proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
• not previous treated for tumor;
• unresectable;
• the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
• sign up consent

You may not qualify if:

• cannot tolerate TAI or surgery;
• known history of other malignancy;
• be allergic to related drugs;
• underwent organ transplantation before;
• be treated before (interferon included);
• known history of HIV infection;
• known history of drug or alcohol abuse;
• have GI hemorrhage or cardiac/brain vascular events within 30 days;
• pregnancy

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

SUN YAT-SEN University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Design

• Study Type: interventional
• Phase: not applicable
• 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 12, 2018
• First Posted: December 17, 2018
• Study Start: July 1, 2016
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2022
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

CN (1)