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.

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 Overview

• Status: Not yet recruiting
• Conditions: Cancer Therapy-induced Thrombocytopenia (CTIT)
• Intervention / Treatment: Drug: rhTPO + hetrombopag; Drug: hetrombopag

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yanxia Shi; Phone Number: 8602087343486; Email: shiyx@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-75 years (inclusive), both sexes eligible.
2. Histologically or cytologically confirmed malignant solid tumor (e.g., lung, breast, gastric, colorectal, genitourinary cancers, etc.).
3. Currently receiving anti-cancer therapy: chemotherapy, radiotherapy, immuno-chemotherapy, targeted therapy, or combinations.
4. Grade ≥3 cancer-therapy-induced thrombocytopenia (PLT <50×10⁹/L).
5. ECOG performance status 0-1.
6. Estimated life expectancy ≥12 weeks.
7. Women of child-bearing potential must have a negative serum pregnancy test within 7 days before first dose and not be breastfeeding; they must agree to use effective contraception from enrollment through 7 days after the last study drug. Men with partners of child-bearing potential must be surgically sterilized or agree to use effective contraception during the same period and must not donate sperm.
8. Willing to participate, able to provide written informed consent, and expected to comply with the study protocol.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Individuals unable to understand the nature of the study or who have not given informed consent.
3. History of any arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep-vein thrombosis, pulmonary embolism) or clinical/laboratory evidence of a hypercoagulable disorder.
4. Cardiac disease within 3 months before screening: grade 3/4 congestive heart failure, arrhythmia requiring medication, myocardial infarction, conditions predisposing to thrombo-embolism (e.g., atrial fibrillation), or QTc prolongation.
5. Thrombocytopenia attributed to: concurrent chemoradiotherapy, non-anti-cancer therapy, oxaliplatin-induced sinusoidal injury, definite immune-mediated thrombocytopenia, severe bleeding symptoms, refractory persistent thrombocytopenia, or bone-marrow involvement proven by biopsy in patients with bone metastases.

6. Significant hepatic impairment:

   • No liver metastases: ALT/AST > 3 × ULN or TBL > 3 × ULN.
   • Liver metastases present: ALT/AST ≥ 5 × ULN or TBL ≥ 5 × ULN.
7. Known or anticipated hypersensitivity/intolerance to TPO-receptor agonists or any ingredient of hetrombopag ethanolamine tablets.
8. Concomitant use of other agents that may affect platelet count (e.g., traditional Chinese medicines, other thrombopoietic agents, antiplatelet drugs).
9. Receipt of any TPO-receptor agonist (eltrombopag, romiplostim, etc.), recombinant human TPO, or recombinant IL-11 within 1 month before screening.
10. Platelet transfusion within 3 days before randomization/first dose.
11. Any condition that, in the investigator's opinion, renders the patient unsuitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental arm; rhTPO 15,000 IU/day subcutaneously + hetrombopag 7.5 mg/day orally, both starting on Day 1 for up to 14 days.	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.
Active Comparator: Control arm; Hetrombopag 7.5 mg/day orally 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving PLT ≥100×10⁹/L or an increase ≥50×10⁹/L from baseline within 14 days of treatment.	within 14 days of treatment.

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients achieving PLT ≥100×10⁹/L or an increase ≥50×10⁹/L from baseline within 7 days Time to PLT recovery to ≥100×10⁹/L Time to PLT increase ≥50×10⁹/L from baseline Lowest (nadir) platelet count recorded Duration of thrombopoietic therapy	within 7 days

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): December 15, 2027

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: hetrombopag
• Other Study ID Numbers: B2025-803-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No