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

Hepatocellular Carcinoma Clinical Trial

Official title:

Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02580253
• Other study ID #: ZYYYMedOncoLT02
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 1, 2017
• Est. completion date: December 2018

Study information

• Verified date: June 2017
• Source: Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

• Additional inclusion criteria were age 18 years or older

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Individualized Chemotherapy
Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
• mFOLFOX6
Oxaliplatin,Fluorouracil

Locations

Country	Name	City	State
China	First affiliated hospital, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desease free Survival		3 years
Secondary	Overall Survival		3 years