MedTrace Logo

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

NCT07334093 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2026-01-12

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2027-11-15
Completion
2027-12-15

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07334093 on ClinicalTrials.gov