CTIT-Chemotherapy Induced ThrombocytopeniaNCT06769685
TPO Combined With TPORA for Solid Tumors Effectiveness of cTit Above Degree II
An observational study of CTIT-Chemotherapy Induced Thrombocytopenia, run by Jinhua Central Hospital at 1 site in China.
Trial summary
This study was an open-label, controlled, single-center, prospective phase II trial. In this prospective, real-world study, consecutive patients meeting eligibility criteria will be enrolled and allocated to: Group A (Grade Ⅱ CTIT, PLT:50-75*10^9/L) and Group B (Grade Ⅲ or higher CTIT，PLT:<50*10^9/L). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CTIT-Chemotherapy Induced Thrombocytopenia
- What is being tested?
- rhTPO and hypertrombopa
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 Feb 2025to 30 Jun 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tumor therapy-related thrombocytopenia treated with thrombopoietic agents
Who may be able to join
- Understand the study procedures and voluntarily sign the informed consent form to voluntarily enroll in this study;
- Age ≥ 18 years old;
- Receive anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) within 14 days prior to study entry;
- Anti-tumor therapy (see the subsequent 'Protocols for Reference' for details);
- Patients with two consecutive platelet counts <75×109/L more than 24 hours apart, with a screening period of 3 days.
Who cannot join
- Previous use of rhTPO or TPORA analogs;
- Prior grade 2 or higher CTIT;
- Patients undergoing clinical interventional studies;
- Patients with a history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disorders, lymphoma, or myelodysplastic disorders;
- Patients with underlying liver disease (e.g., cirrhosis or chronic hepatitis) and no primary or metastatic cancer in the liver will be excluded if ALT/AST >3X ULN or total bile >3X ULN);
- Patients with the presence of primary or metastatic liver cancer will be excluded if ALT/AST >5X ULN or total bile >5X ULN;
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- Patients with a history of symptomatic venous thrombotic events (e.g., DVT or pulmonary embolism) and symptomatic arterial thrombotic events (e.g., myocardial infarction, ischemic cerebral vascular accident, or transient ischemic attack) who are unable to tolerate anticoagulant therapy will be ineligible, and patients with D-dimer greater than 10,000 g/L will also be excluded;
- Serious concomitant medical conditions that may interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring intravenous antibiotics;
- Pregnant/nursing mothers and patients who do not wish to use contraception; Inability to understand the research nature of the study or failure to obtain informed consent;
- Other conditions that, in the judgment of the investigator, make inclusion in the study inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study was an open-label, controlled, single-center, prospective phase II trial. In this prospective, real-world study, consecutive patients meeting eligibility criteria will be enrolled and allocated to: Group A (Grade Ⅱ CTIT, PLT:50-75*10^9/L) and Group B (Grade Ⅲ or higher CTIT，PLT:<50*10^9/L). Both groups received rhTPO and Hetrombopag treatment. A target sample size of 100 participants will be observed to characterize the clinical features and treatment patterns of cancer therapy-induced thrombocytopenia. Recombinant human thrombopoietin (rhTPO) and hetrombopag will be administered until a platelet count ≥ 75 × 10⁹/L is achieved. Beyond the protocol-specified dual therapy, basic management, including supportive care or concomitant medications-will remain at the investigator's discretion.
Read the detailed description
This research will gather real-world data on an investigational drug in a prospective manner, aiming to monitor 100 patients to explore the characteristics and treatment approaches of thrombocytopenia associated with tumor therapy. In this prospective, real-world study, consecutive patients meeting eligibility criteria will be enrolled and allocated to: Group A (Grade Ⅱ CTIT, PLT:50-75*10^9/L) and Group B (Grade Ⅲ or higher CTIT，PLT:<50*10^9/L).
Patients with platelet counts between 50×10^9/L and 75×10^9/L will be randomly allocated to either Arm A or Arm B. In Arm A and Arm B, participants will receive standard care, which may include medications such as interleukin-11, leucogen, and yixuesheng. Meanwhile, individuals in Arm B will be administered recombinant human thrombopoietin (rhTPO) and eltrombopag until their platelet count reaches or exceeds 75×10^9/L.
This study will prospectively gather relevant patient information. Data collection will occur over two tumor treatment cycles and during the administration of thrombopoietin-promoting drugs for all participants. Specifically, the following data will be collected for each patient across two consecutive chemotherapy cycles (Cycle N and Cycle N+1):
- Patient baseline characteristics
- Dosage, frequency, and duration of administration for each study drug
- Details of concomitant medications related to the study drugs, including names, dosages, frequencies, and durations of administration
- Laboratory test results and imaging examination findings before, during, and after treatment with each study drug
- Records of any adverse events
The aim is to comprehensively document these aspects to ensure thorough analysis and evaluation.
- Being tested
- rhTPO, hypertrombopa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTPODrug
In group A, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. In group B, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L.
hypertrombopaDrug
In group A, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. In group B, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L.
| Study group | Role | What they receive |
|---|---|---|
| Group A | For ctit patients with platelet counts ≥50×109/L and <75×109/L, they were randomized into groups A. Receives: Drug: rhTPO; Drug: hypertrombopa | |
| Group B | For ctit patients with platelet counts <50×109/L, they were randomized into groups B. Receives: Drug: rhTPO; Drug: hypertrombopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for platelets to rise from nadir to 75 x 109/L
Time for platelets to rise from nadir to 75 x 109/L
Measured: up to 4 weeks
Secondary outcomes (1)
The time required for platelet count to rise to 100×10⁹/L, the proportion of patients with a delay of ≥7 days in the next cycle, bleeding, receiving platelet transfusion and treatment-related adverse reactions.
The time required for platelet count to rise to 100×10⁹/L, the proportion of patients with a delay of ≥7 days in the next cycle, bleeding, receiving platelet transfusion and treatment-related adverse reactions.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start27 Feb 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTIT-Chemotherapy Induced ThrombocytopeniaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinhua Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jianfei Fu, Jinhua Central Hospital
- Investigators
- Jianfei Fu, PhD, Principal investigator, Director of Medical Oncology Department of Jinhua Municipal Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769685
- Sponsor's protocol ID
- JinhuaCH
- Status last verified
- Dec 2025
- First submitted
- 1 Jan 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TPO Combined With TPORA for Solid Tumors Effectiveness of cTit Above Degree II
- ClinicalTrials.gov ID
- NCT06769685
- Acronym / sponsor ID
- JinhuaCH
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jinhua Central HospitalUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 10 Jan 2025 (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.
This study was an open-label, controlled, single-center, prospective phase II trial. In this prospective, real-world study, consecutive patients meeting eligibility criteria will be enrolled and allocated to: Group A (Grade Ⅱ CTIT, PLT:50-75*10^9/L) and Group B (Grade Ⅲ or higher CTIT，PLT:<50*10^9/L). Both groups received rhTPO and Hetrombopag treatment. A target sample size of 100 participants will be observed to characterize the clinical features and treatment patterns of cancer therapy-induced thrombocytopenia. Recombinant human thrombopoietin (rhTPO) and hetrombopag will be administered until a platelet count ≥ 75 × 10⁹/L is achieved. Beyond the protocol-specified dual therapy, basic management, including supportive care or concomitant medications-will remain at the investigator's discretion.
Detailed description
This research will gather real-world data on an investigational drug in a prospective manner, aiming to monitor 100 patients to explore the characteristics and treatment approaches of thrombocytopenia associated with tumor therapy. In this prospective, real-world study, consecutive patients meeting eligibility criteria will be enrolled and allocated to: Group A (Grade Ⅱ CTIT, PLT:50-75*10^9/L) and Group B (Grade Ⅲ or higher CTIT，PLT:<50*10^9/L).
Patients with platelet counts between 50×10^9/L and 75×10^9/L will be randomly allocated to either Arm A or Arm B. In Arm A and Arm B, participants will receive standard care, which may include medications such as interleukin-11, leucogen, and yixuesheng. Meanwhile, individuals in Arm B will be administered recombinant human thrombopoietin (rhTPO) and eltrombopag until their platelet count reaches or exceeds 75×10^9/L.
This study will prospectively gather relevant patient information. Data collection will occur over two tumor treatment cycles and during the administration of thrombopoietin-promoting drugs for all participants. Specifically, the following data will be collected for each patient across two consecutive chemotherapy cycles (Cycle N and Cycle N+1):
- Patient baseline characteristics
- Dosage, frequency, and duration of administration for each study drug
- Details of concomitant medications related to the study drugs, including names, dosages, frequencies, and durations of administration
- Laboratory test results and imaging examination findings before, during, and after treatment with each study drug
- Records of any adverse events
The aim is to comprehensively document these aspects to ensure thorough analysis and evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Drug: rhTPO, Drug: hypertrombopaFor ctit patients with platelet counts ≥50×109/L and <75×109/L, they were randomized into groups A. |
| Group B | – | Drug: rhTPO, Drug: hypertrombopaFor ctit patients with platelet counts <50×109/L, they were randomized into groups B. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tumor therapy-related thrombocytopenia treated with thrombopoietic agents
Key inclusion criteria (5 listed)
- Understand the study procedures and voluntarily sign the informed consent form to voluntarily enroll in this study;
- Age ≥ 18 years old;
- Receive anti-tumor therapy (including chemotherapy, targeted therapy, immunotherapy, etc.) within 14 days prior to study entry;
- Anti-tumor therapy (see the subsequent 'Protocols for Reference' for details);
- Patients with two consecutive platelet counts <75×109/L more than 24 hours apart, with a screening period of 3 days.
Key exclusion criteria (10 listed)
- Previous use of rhTPO or TPORA analogs;
- Prior grade 2 or higher CTIT;
- Patients undergoing clinical interventional studies;
- Patients with a history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disorders, lymphoma, or myelodysplastic disorders;
- Patients with underlying liver disease (e.g., cirrhosis or chronic hepatitis) and no primary or metastatic cancer in the liver will be excluded if ALT/AST >3X ULN or total bile >3X ULN);
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 |
|---|---|---|
| rhTPOIn group A, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. In group B, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. | Drug | Group A, Group B |
| hypertrombopaIn group A, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. In group B, they were treated with rhTPO and hypertrombopa, and were medicated until their PLT was ≥75×109/L. | Drug | Group A, Group B |
Primary outcome
Time for platelets to rise from nadir to 75 x 109/L
Time frame: up to 4 weeks
Time for platelets to rise from nadir to 75 x 109/L
1 secondary outcome
The time required for platelet count to rise to 100×10⁹/L, the proportion of patients with a delay of ≥7 days in the next cycle, bleeding, receiving platelet transfusion and treatment-related adverse reactions.
Time frame: up to 4 weeks
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 19 Dec 2025.
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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.
Jianfei Fu, PhD principal investigator
Director of Medical Oncology Department of Jinhua Municipal Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CTIT-Chemotherapy Induced Thrombocytopenia, run by Jinhua Central Hospital at 1 site in China.
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 5 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for platelets to rise from nadir to 75 x 109/L (time frame: up to 4 weeks). 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 19 Dec 2025.