A Study of Hetrombopag Combined With rhTPO in the Treatment of Cancer Therapy-induced Thrombocytopenia (CTIT) in Solid Tumor Patients.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rhTPO + hetrombopag, hetrombopag.
- Who it may be relevant to
- Registry conditions: Cancer Therapy-induced Thrombocytopenia (CTIT). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
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.
Primary outcome measures
- Proportion of patients achieving PLT ≥100×10⁹/L or an increase ≥50×10⁹/L from baseline within 14 days of treatment. [Time frame: within 14 days of treatment.]
Secondary outcome measures (1)
- 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 [Time frame: within 7 days]
Eligibility criteria
Inclusion criteria
- Age 18-75 years (inclusive), both sexes eligible.
- Histologically or cytologically confirmed malignant solid tumor (e.g., lung, breast, gastric, colorectal, genitourinary cancers, etc.).
- Currently receiving anti-cancer therapy: chemotherapy, radiotherapy, immuno-chemotherapy, targeted therapy, or combinations.
- Grade ≥3 cancer-therapy-induced thrombocytopenia (PLT <50×10⁹/L).
- ECOG performance status 0-1.
- Estimated life expectancy ≥12 weeks.
- 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.
- Willing to participate, able to provide written informed consent, and expected to comply with the study protocol.
Exclusion criteria
- Pregnant or breastfeeding women.
- Individuals unable to understand the nature of the study or who have not given informed consent.
- 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.
- 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.
- 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.
- 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.
- Known or anticipated hypersensitivity/intolerance to TPO-receptor agonists or any ingredient of hetrombopag ethanolamine tablets.
- Concomitant use of other agents that may affect platelet count (e.g., traditional Chinese medicines, other thrombopoietic agents, antiplatelet drugs).
- Receipt of any TPO-receptor agonist (eltrombopag, romiplostim, etc.), recombinant human TPO, or recombinant IL-11 within 1 month before screening.
- Platelet transfusion within 3 days before randomization/first dose.
- Any condition that, in the investigator's opinion, renders the patient unsuitable for enrollment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07334093 · B2025-803-01