Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity Assay for Hepatocellular Carcinoma After Liver Transplantation

NCT02580253 | Withdrawn Phase 2

• 1 other identifier: ZYYYMedOncoLT02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, controlled study that will explore the efficacy of individualized adjuvant chemotherapy based on the adenosine triphosphate tumor chemosensitivity assay for patients with hepatocellular carcinoma after liver transplantation.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Desease free Survival

  3 years

Secondary Outcomes (1)

• Overall Survival

  3 years

Study Arms (2)

Individualized Chemotherapy

EXPERIMENTAL

Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)

Drug: Individualized Chemotherapy

mFOLFOX6

ACTIVE COMPARATOR

Oxaliplatin (85 mg/m2 )+Fluorouracil (2800 mg/m2 ) q2w

Drug: mFOLFOX6

Interventions

Individualized Chemotherapy DRUG

Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)

Individualized Chemotherapy

mFOLFOX6 DRUG

Oxaliplatin,Fluorouracil

mFOLFOX6

Eligibility Criteria

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

You may qualify if:

• Patients who had experienced liver transplantation with histologically confirmed advanced hepatocellular carcinoma with more one risk factor (tumour burden \>8 cm, AFP\>400 ng/mL,poorly differentiated,vessels invasion )
• No extrahepatic metastasis confirmed with computed tomography (CT) or magnetic resonance imaging (MRI)
• Karnofsky performance status (KPS) of at least 70%
• Adequate renal function, defined as creatinine clearance greater than 30 mL/min)
• Adequate hepatic function, defined as ALT and AST less than 5× upper limit of normal
• Adequate bone marrow function, defined as platelets greater than 100×10E9/L and WBC greater than 3.5×10E9/L.

You may not qualify if:

• The presence of any severe concomitant disease that could interrupt the planned treatment; intractable pain
• Hypersensitivity to study drugs
• Serious cardiovascular disease (eg, unstable coronary artery disease or myocardial infarction within 4 weeks of study start)
• National Cancer Institute CommonToxicity Criteria (NCI-CTC) grade 3 or 4 sensory or motor neuropathy
• Prior or concurrent malignancy (other than pancreatic cancer)
• Female, pregnancy or breastfeeding.

Sponsors & Collaborators

• Zhejiang University: lead

Study Sites (1)

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

Related Publications (1)

• Lin HS, Wan RH, Gao LH, Li JF, Shan RF, Shi J. Adjuvant chemotherapy after liver transplantation for hepatocellular carcinoma: a systematic review and a meta-analysis. Hepatobiliary Pancreat Dis Int. 2015 Jun;14(3):236-45. doi: 10.1016/s1499-3872(15)60373-3.

  PMID: 26063023 BACKGROUND

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: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 17, 2015
• First Posted: October 20, 2015
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 17, 2020

Record last verified: 2017-06

Locations

CN (1)