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

Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02580253

Enrollment

Registered

2015-10-20

Start date

2017-11-01

Completion date

2018-12-31

Last updated

2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

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.

Interventions

DRUGIndividualized Chemotherapy

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

DRUGmFOLFOX6

Oxaliplatin,Fluorouracil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Desease free Survival	3 years

Secondary

Measure	Time frame
Overall Survival	3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026