Cancer Therapy-induced Thrombocytopenia (CTIT)Phase 2NCT07334093
A Study of Hetrombopag Combined With rhTPO in the Treatment of Cancer Therapy-induced Thrombocytopenia (CTIT) in Solid Tumor Patients.
A Phase 2 study testing rhTPO + hetrombopag and hetrombopag in people with Cancer Therapy-induced Thrombocytopenia (CTIT), run by Sun Yat-sen University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer Therapy-induced Thrombocytopenia (CTIT)
- What is being tested?
- rhTPO + hetrombopag and hetrombopag
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 15 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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.
Read more
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.
- Being tested
- rhTPO + hetrombopag, hetrombopag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPO + hetrombopagDrug
rhTPO 15,000 IU/day subcutaneously + hetrombopag 7.5 mg/day orally, both starting on Day 1 for up to 14 days.
hetrombopagDrug
Hetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | rhTPO 15,000 IU/day subcutaneously + hetrombopag 7.5 mg/day orally, both starting on Day 1 for up to 14 days. Receives: Drug: rhTPO + hetrombopag |
| Control arm | Active comparator | Hetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days. Receives: Drug: hetrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving PLT ≥100×10⁹/L or an increase ≥50×10⁹/L from baseline within 14 days of treatment.
Measured: within 14 days of treatment.
Secondary outcomes (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
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start31 Jan 2026 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Therapy-induced Thrombocytopenia (CTIT)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Yanxia, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334093
- Sponsor's protocol ID
- B2025-803-01
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07334093
- Acronym / sponsor ID
- B2025-803-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: rhTPO + hetrombopagrhTPO 15,000 IU/day subcutaneously + hetrombopag 7.5 mg/day orally, both starting on Day 1 for up to 14 days. |
| Control arm | Active comparator | Drug: hetrombopagHetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rhTPO + hetrombopagrhTPO 15,000 IU/day subcutaneously + hetrombopag 7.5 mg/day orally, both starting on Day 1 for up to 14 days. | Drug | Experimental arm |
| hetrombopagHetrombopag 7.5 mg/day orally starting on Day 1 for up to 14 days. | Drug | Control arm |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rhTPO + hetrombopag and hetrombopag in people with Cancer Therapy-induced Thrombocytopenia (CTIT), run by Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanxia Shi (8602087343486, shiyx@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.