NCT07334093

A Study of Hetrombopag Combined With rhTPO in the Treatment of Cancer Therapy-induced Thrombocytopenia (CTIT) in Solid Tumor Patients.

A Multicenter, Randomized Controlled Phase II Clinical Study of Hetrombopag Combined With rhTPO in the Treatment of Cancer Therapy-induced Thrombocytopenia (CTIT) in Solid Tumor Patients.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer Therapy-induced Thrombocytopenia (CTIT)

Interventions

Type	Name	Description
DRUG	rhTPO + hetrombopag	rhTPO 15,000 IU/day subcutaneously + hetrombopag 7.5 mg/day orally, both starting on Day 1 for up to 14 days.
DRUG	hetrombopag	Hetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days.

Timeline

• Start date: 2026-01-31
• Primary completion: 2027-11-15
• Completion: 2027-12-15
• First posted: 2026-01-12
• Last updated: 2026-01-12