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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Cancer Hospital

About this trial

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.

Eligibility criteria

Qualifiers

1. Aged 18 to 75 years old, regardless of gender;

2. Patients with nasopharyngeal carcinoma confirmed by pathological or cytological examination;

3. Currently receiving treatment with the Gemcitabine + Cisplatin (GP) regimen at a 21-day cycle, with the lowest platelet count < 75×10⁹/L in the previous chemotherapy cycle, and expected to maintain the same chemotherapy regimen for at least 2 more cycles;

4. Estimated survival time ≥ 12 weeks;

Disqualifiers

1. Thrombocytopenia not caused by cancer therapy occurring within 6 months prior to screening, including but not limited to hepatic cirrhosis with hypersplenism, infection, and bleeding;

2. Having other hematopoietic system diseases besides chemotherapy-induced thrombocytopenia, including leukemia, primary immune thrombocytopenia (ITP), myeloproliferative diseases (MPDs), multiple myeloma (MM), myelodysplastic syndromes (MDS), etc.;

3. Complicated with bone marrow involvement or bone marrow metastasis;

4. Having received pelvic, spinal radiotherapy or large-field bone irradiation within 3 months prior to screening;

Trial design

Treatments tested in this trial

  • herombopag olamine tablets

Treatment groups

35 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators