Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07334093
Brief Summary:
Objective To evaluate the efficacy and safety of hetrombopag plus rhTPO versus hetrombopag monotherapy for CTIT in solid-tumor patients.
Participants 204 histologically- or cytologically-confirmed solid-tumor patients with ≥grade 3 thrombocytopenia following anti-cancer treatment.
Design
Open-label, multicenter, randomized controlled phase II study. Patients are randomized 1:1 into two arms:
Experimental arm (N=102):
rhTPO 15,000 IU/day subcutaneously + hetrombopag 7.5 mg/day orally, both starting on Day 1 for up to 14 days.
Control arm (N=102):
Hetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days. Stopping \& Rescue Rules Stop study drug if PLT ≥100×10⁹/L or rises ≥50×10⁹/L from baseline. If PLT ≤10×10⁹/L or \<20×10⁹/L with bleeding risk, give rescue therapy (platelet transfusion or investigator-chosen alternative).
Primary Endpoint Proportion of patients achieving PLT ≥100×10⁹/L or an increase ≥50×10⁹/L from baseline within 14 days of treatment.
Study:
NCT07334093
Study Brief:
Protocol Section:
NCT07334093