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

NCT ID: NCT02580253

Last Updated: 2020-02-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Individualized Chemotherapy

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

Group Type: EXPERIMENTAL

Individualized Chemotherapy

Intervention Type: DRUG

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

mFOLFOX6

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

Group Type: ACTIVE_COMPARATOR

mFOLFOX6

Intervention Type: DRUG

Oxaliplatin,Fluorouracil

Interventions

Individualized Chemotherapy

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

Intervention Type: DRUG

mFOLFOX6

Oxaliplatin,Fluorouracil

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Weijia Fang, MD

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First affiliated hospital, Zhejiang University

Hangzhou, Zhejiang, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 26063023 (View on PubMed)

Other Identifiers

ZYYYMedOncoLT02

Identifier Type: -

Identifier Source: org_study_id