A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae

Summary

This study is a prospective clinical study enrolling breast cancer patients at high risk of chemotherapy-induced thrombocytopenia (CTIT). It aims to investigate the efficacy and safety of hetrombopag in the secondary prophylaxis of CTIT. Breast cancer patients with histologically or cytologically confirmed disease were enrolled after signing the informed consent form and were randomly assigned in a 1:1:1 ratio to three Arms. Stratification factors for randomization included the number of prior antineoplastic treatment cycles (\>2 cycles vs. ≤2 cycles). Arm 1: No prophylactic use of hetrombopag Arm 2: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 of the first chemotherapy cycle (C1D1) continuously until the end of the second chemotherapy cycle Arm 3: Hetrombopag at an initial dose of 7.5 mg once daily, administered from Day 1 (C1D1) to Day 14 (C1D14) of the first chemotherapy cycle; the dosage and administration schedule in the second chemotherapy cycle were identical to those in the first cycle; Treatment continued until patients completed the protocol-specified treatment and follow-up, experienced intolerable toxicity, withdrew informed consent, initiated alternative antitumor therapy, died, or met any other treatment discontinuation criteria specified in the protocol, whichever occurred first.

Timeline

Start

2026-05-28

Primary completion

2028-02-29

Completion

2028-03-31

Publications

• Background Qin S, Wang Y, Yao J, Liu Y, Yi T, Pan Y, Chen Z, Zhang X, Lu J, Yu J, Zhang Y, Cheng P, Mao Y, Zhang J, Fang M, Zhang Y, Lv J, Li R, Dou N, Tang Q, Ma J. Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study. Ther Adv Med Oncol. 2024 Jun 14;16:17588359241260985. doi: 10.1177/17588359241260985. eCollection 2024.
• Background Kuter DJ. Treatment of chemotherapy-induced thrombocytopenia in patients with non-hematologic malignancies. Haematologica. 2022 Jun 1;107(6):1243-1263. doi: 10.3324/haematol.2021.279512.
• Background Jin G, Wu Y, She Z, Ma X, Deng S, Wang W, Wu Y, Li Q. Prophylactic Administration of Recombinant Human Thrombopoietin in the Secondary Prevention of Thrombocytopenia Induced by XELOX Adjuvant Chemotherapy in Patients With Stage III Colorectal Cancer. Am J Ther. 2021 Apr 7;28(4):e513-e516. doi: 10.1097/MJT.0000000000001331. No abstract available.
• Background Li Q, Jin G, Jiang C, Zhang Z, Hou J, Zhao J, Chen F, Li Z. Prophylactic administration of recombinant human thrombopoietin attenuates XELOX or SOX regimen-induced thrombocytopaenia. Arch Med Sci. 2021 Aug 9;17(5):1440-1446. doi: 10.5114/aoms/141134. eCollection 2021. No abstract available.
• Background Xu Y, Song X, Du F, Zhao Q, Liu L, Ma Z, Lu S. A Randomized Controlled Study of rhTPO and rhIL-11 for the Prophylactic Treatment of Chemotherapy-Induced Thrombocytopenia in Non-Small Cell Lung Cancer. J Cancer. 2018 Nov 25;9(24):4718-4725. doi: 10.7150/jca.26690. eCollection 2018.
• Background Chen M, Li L, Xia Q, Chen X, Liao Z, Wang C, Shen B, Zhou M, Zhang Q, Zhang Y, Qian L, Yuan X, Wang Z, Xue C, An X, Liu B, Gu K, Hou M, Wang X, Wang W, Li E, Zhong J, Cheng J, Shu Y, Yang N, Wang H, Yang R, Liu T, Deng T, Ma F, Liao W, Qiu W, Chen Y, Chen X, Zhang M, Xu R, Li X, Feng J, Ba Y, Shi Y. A real-world observation on thrombopoietic agents for patients with cancer treatment-induced thrombocytopenia in China: A multicenter, cross-sectional study. Cancer. 2024 Apr 15;130(S8):1524-1538. doi: 10.1002/cncr.35292. Epub 2024 Mar 22.
• Background Bashour FN, Teran JC, Mullen KD. Prevalence of peripheral blood cytopenias (hypersplenism) in patients with nonalcoholic chronic liver disease. Am J Gastroenterol. 2000 Oct;95(10):2936-9. doi: 10.1111/j.1572-0241.2000.02325.x.

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