The study consists of five sequential periods: * Screening (≤ 4 weeks) * Correction phase * Maintenance phase (first treatment cycle, Cycle 1) * Observation phase (second treatment cycle, Cycle 2) * Follow-up Eligible subjects are gynaecological-cancer patients who developed ≥ grade-2 cancer-therapy-induced thrombocytopenia (CTIT) after anti-tumour therapy, i.e. platelet count \< 75 × 10⁹/L. * Stage 1\*\* - Prospective, multicentre, randomised clinical study (to inform the confirmatory stage 2) \*\*Cohort 1 (n = 30)\*\* Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. Within 24 h after completion of Cycle 1 anti-cancer therapy (end of chemotherapy if combined; otherwise end of investigational product on that day) restart hetrombopag 7.5 mg p.o. daily and continue until the last day of Cycle 1 (C1D21). \*\*Cohort 2 (n = 30)\*\* Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. During Cycle 1, monitor PLT closely; if PLT falls \< 75 × 10⁹/L, initiate hetrombopag 7.5 mg p.o. daily and continue until C1D21. \*\*Stage 2\*\* - Prospective, multicentre, randomised, controlled clinical study \*(preliminary design; sample size and details will be refined after stage-1 results)\* \*\*Experimental arm (n = 92)\*\* Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. Restart within 24 h after completion of Cycle 1 therapy and continue daily until C1D21. \*\*Control arm (n = 92)\*\* Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. During Cycle 1, monitor PLT; if PLT \< 75 × 10⁹/L, initiate hetrombopag 7.5 mg p.o. daily until C1D21. \*\*Correction-phase rules\*\* Discontinue hetrombopag once PLT ≥ 100 × 10⁹/L. If after ≥ 14 days of hetrombopag correction PLT remains \< 100 × 10⁹/L and the next treatment cycle has not started, the investigator may resume hetrombopag or institute alternative platelet-enhancing rescue therapy at their discretion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
244
Correction phase: start hetrombopag 7.5 mg orally once daily and continue until platelet count normalizes (PLT ≥ 100 × 10⁹/L). Within 24 h after completion of Cycle 1 anti-cancer therapy-defined as the end of chemotherapy infusion if on a combined regimen, or the end of study drug administration on that day for non-chemotherapy regimens-restart hetrombopag 7.5 mg orally once daily and maintain until the last day of Cycle 1 (C1D21).
Proportion of subjects achieving a treatment response
Treatment-response criteria (all must be met): 1. Completed the entire first treatment cycle (Cycle 1) with a platelet count ≥ 100 × 10⁹/L at C1D21 (window: +4 days). 2. Received no rescue therapy for thrombocytopenia (e.g., platelet transfusion, rhIL-11, rhTPO) from the start of Cycle 1 through C1D21 (window: +4 days). 3. Had no Cycle 2 modifications attributable to CTIT: no delay ≥ 4 days, no dose reduction ≥ 15 %, and no treatment suspension.
Time frame: At the end of the first cycle (each cycle is 28 days).
Huaiwu Lu
CONTACT
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