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NOT YET RECRUITING
NCT07252375
PHASE2

A Clinical Study of Hetrombopag for Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma

Sponsor: Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

This study is a single-arm, exploratory, self-controlled clinical trial for the prevention of thrombocytopenia induced by gemcitabine plus cisplatin in the treatment of nasopharyngeal carcinoma. It aims to investigate the efficacy and safety of hetrombopag for the secondary prevention of thrombocytopenia caused by gemcitabine plus cisplatin in patients with nasopharyngeal carcinoma. The study protocol has been reviewed and approved by the Institutional Ethics Committee of Fujian Cancer Hospital, allowing the conduct of this clinical study.

Official title: A Single-Arm, Exploratory, Self-Controlled Clinical Study of Hetrombopag for Secondary Prevention of Thrombocytopenia Induced by Gemcitabine Plus Cisplatin in the Treatment of Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2025-11-30

Completion Date

2028-11-30

Last Updated

2025-11-26

Healthy Volunteers

No

Interventions

DRUG

herombopag olamine tablets

Oral Hetrombopag Olamine Tablets will be initiated at a daily dose of 5 mg (initial dose) on Day 1 (D1) of each chemotherapy cycle, and administered continuously until the start of the next chemotherapy cycle. During the oral administration period, blood routine examinations of subjects will be collected every 3-5 days, and the dosage of hetrombopag will be adjusted according to the Platelet Count (PIT). The dosage adjustment rules are as follows: When PLT ≥ 100 × 10⁹/L, discontinue administration; When 50 × 10⁹/L ≤ PLT \< 100 × 10⁹/L, increase the daily dose by 2.5 mg; When PLT \< 50 × 10⁹/L, increase the daily dose by 5 mg; Note: When the platelet count is \< 10.0 × 10⁹/L or there is a bleeding risk, rescue measures such as platelet transfusion may be considered based on clinical practice.