Effect of Adjuvant Therapy by Sorafenib, Oxaliplatin and S-1

NCT02129322 | Withdrawn Phase 2

• 1 other identifier: ZYYYMedOncoLT01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to investigate the effect of adjuvant therapy by Sorafenib, Oxaliplatin and S-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Time to Recurrence (TTR)

  Time to Recurrence

  within five years after liver transplantation

Secondary Outcomes (1)

• Overall survival (OS)

  within the five years after liver transplantation

Other Outcomes (1)

• Circulative tumor cell (CTC) level change

  within one year after liver transplantation

Study Arms (2)

Sorafenib

ACTIVE COMPARATOR

Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : Sorafenib maintenance

Drug: Sorafenib; Drug: S-1; Drug: Oxaliplatin

S-1 and Sorafenib

EXPERIMENTAL

Leading 4 cycles: S-1 + Oxaliplatin Q3W + Sorafenib daily Sequential : 4 cycles of S-1 + Sorafenib maintenance

Drug: Sorafenib; Drug: S-1; Drug: Oxaliplatin

Interventions

Sorafenib DRUG

S-1 and Sorafenib; Sorafenib

S-1 DRUG

S-1 and Sorafenib; Sorafenib

Oxaliplatin DRUG

S-1 and Sorafenib; Sorafenib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hepatocellular carcinoma after liver transplantation
• Major organ (heart, lung and brain) function was normal

You may not qualify if:

• Any active infectious process
• The presence of clinically confirmed extrahepatic metastasis
• Postoperative dysfunction of any organ

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First affiliated hospital, Zhejiang University

Hangzhou, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib; S 1 (combination); Oxaliplatin

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Coordination Complexes

Study Officials

• Weijia fang

  First Affiliated Hospital,Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First affiliated hospital, Zhejiang University

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 2, 2014
• Study Start: July 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2019
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

CN (1)