Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury

Nanchang University

Status and phase: Unknown; Phase 4

Conditions: Liver Injury, Drug-Induced

Treatments: Drug: docetaxel and cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03069820

HL001

Details and patient eligibility

About

The most common toxicity of TP (docetaxel and cisplatin) chemotherapy is chemotherapy-induced liver injury. However, patients don't always experience same chemotherapy-induced liver injury for the same drugs. Therefore, the investigators designed the present study to clarify risk factors associated with the development of severe hepatotoxicity after therapy with docetaxel and cisplatin for nasopharyngeal carcinoma (NPC).

Full description

Nasopharyngeal carcinoma (NPC) is one of the most common malignancies in southern China , with an annual incidence of 15 to 50 cases per 100,000 people. NPC is both radiosensitive and chemosensitive. Recently, many new drugs including docetaxel and cisplatin have been incorporated in the induction chemotherapy phase of NPC. The most common toxicity of TP (docetaxel and cisplatin) chemotherapy is chemotherapy-induced liver injury, and appropriate management of these toxicities can help patients improve tolerance for chemotherapy. However, patients don't always experience same chemotherapy-induced liver injury for the same drugs. Therefore, it is important to determine the risk factors to predict chemotherapy-induced liver injury. The investigators designed the present study to clarify risk factors associated with the development of severe hepatotoxicity after therapy with docetaxel and cisplatin for nasopharyngeal carcinoma (NPC).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with advanced nasopharyngeal carcinoma.
• Patients scheduled to receive the first line, first cycle TP (docetaxel and cisplatin) chemotherapy.
• Normal liver function biomarkers including ALT,AST,ALP,TBIL before recruitment.
• Minimum age of 18 years.
• Life expectancy at least 3 months.

Exclusion criteria

• Patients previously received chemotherapy
• Patients who have liver metastases.
• Patients who take other drugs that may affect liver function

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Study Population

Experimental group

Description:

Patients with advanced nasopharyngeal carcinoma scheduled to receive the first line, first cycle TP (docetaxel and cisplatin) chemotherapy

Treatment:

Drug: docetaxel and cisplatin