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

• Sponsor: Zhejiang University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02580253
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Individualized Chemotherapy; Drug: mFOLFOX6	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity
• Anticipated Study Start Date: Nov 1, 2017
• Anticipated Primary Completion Date: Nov 1, 2018
• Anticipated Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Individualized Chemotherapy Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)	Drug: Individualized Chemotherapy; Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
Active Comparator: mFOLFOX6 Oxaliplatin (85 mg/m2 )+Fluorouracil (2800 mg/m2 ) q2w	Drug: mFOLFOX6; Oxaliplatin,Fluorouracil

Outcome Measures

Primary Outcome Measures

1. Desease free Survival [3 years]

Secondary Outcome Measures

1. Overall Survival [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First affiliated hospital, Zhejiang University	Hangzhou	Zhejiang	China	310006

Sponsors and Collaborators

• Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Weijia Fang, MD, Director, Zhejiang University
• ClinicalTrials.gov Identifier: NCT02580253
• Other Study ID Numbers: ZYYYMedOncoLT02
• First Posted: Oct 20, 2015
• Last Update Posted: Feb 17, 2020
• Last Verified: Jun 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular

Study Results

No Results Posted as of Feb 17, 2020