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.
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;
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;
Single group
herombopag olamine tablets
DrugOral 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.
Incidence Rate of Grade 3 or Higher Cancer Therapy-Induced Thrombocytopenia (CTIT)
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