Sequential Hetrombopag and Recombinant Human Thrombopoietin for Cancer Therapy-Induced Thrombocytopenia

November 8, 2026 updated by: Feng Wang, The First Affiliated Hospital of Zhengzhou University

A Multicenter, Exploratory Clinical Study of Sequential Hetrombopag and Recombinant Human Thrombopoietin for Cancer Therapy-Induced Thrombocytopenia

This is a multicenter, randomized, exploratory clinical study. The study plans to enroll 96 participants with cancer therapy-induced thrombocytopenia. participants will be stratified by baseline platelet countand randomized 1:1 to the hetrombopag sequential group (Experimental Group A) or the recombinant human thrombopoietin (rhTPO) group (Experimental Group B).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-75 years (inclusive), male or female;
  • Patients with histologically or cytologically confirmed malignant tumors, including but not limited to lung cancer, breast cancer, colorectal cancer, gastric cancer, etc.;
  • Currently receiving anticancer therapy in 21-day cycles, with grade 3 or higher thrombocytopenia during treatment, and expected to be able to receive the current anticancer regimen for ≥ 1 more cycle;
  • ECOG PS score 0-2;
  • With permitted use of red blood cells, erythropoietin, and recombinant human granulocyte colony-stimulating factor consistent with routine clinical practice: absolute neutrophil count (ANC) ≥ 1.0×10^9/L and hemoglobin (Hb) ≥ 80 g/L;
  • No significant hepatic impairment;
  • No significant renal impairment;
  • Expected survival ≥ 12 weeks;
  • Female participants of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose, must not be lactating, and must agree to use effective contraception during the study and for 7 days after the last dose of study drug; male participants whose partners are women of childbearing potential must be surgically sterilized or must agree to use reliable contraception from the signing of the informed consent form until 7 days after the last dose of study drug;
  • Voluntary participation in this study with signed informed consent and good compliance.

Exclusion Criteria:

  • Concomitant hematopoietic system diseases, including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative neoplasms, multiple myeloma, and myelodysplastic syndromes;
  • Other diseases causing thrombocytopenia other than cancer therapy-induced thrombocytopenia (CTIT) within 6 months before randomization, including but not limited to chronic liver disease and hypersplenism;
  • Uncontrolled active infection;
  • Tumor bone marrow invasion or bone marrow metastasis;
  • Severe cardiac clinical symptoms or diseases within 6 months before randomization;
  • Arterial or venous thrombotic events (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism) within 3 months before randomization, or clinical symptoms and history suggestive of thrombophilia;
  • Concomitant severe bleeding symptoms or clear clinical manifestations of bleeding tendency, such as gastrointestinal or cerebral hemorrhage;
  • Conditions affecting drug absorption (e.g., dysphagia, history of total gastrectomy);
  • Receipt of whole-pelvis, whole-spine, or extensive sternal radiotherapy in the previous cycle or expected during the current cycle;
  • Treatment with rhIL-11, rhTPO and/or TPO-RA drugs within 7 days before randomization;
  • Treatment with romiplostim or romiplostim N01 within 1 month before randomization;
  • Platelet transfusion within 3 days before randomization;
  • Known or expected allergy or intolerance to the active ingredients or excipients of the study drug;
  • Known history of positive human immunodeficiency virus (HIV) test or acquired immunodeficiency syndrome (AIDS);
  • Known active viral hepatitis;
  • Any other condition that, in the investigator's opinion, poses a significant risk to the subject's health or safety or may affect the efficacy evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Hetrombopag sequential group
Drug: Hetrombopag and recombinant human thrombopoietin

hetrombopag (orally) + rhTPO (subcutaneous injection)
Experimental: Recombinant human thrombopoietin group
Drug: Recombinant Human Thrombopoietin

rhTPO (subcutaneous injection)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: Up to 6 weeks

Proportion of participants achieving treatment response
Up to 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adverse events
Time Frame: Up to 8 weeks
Up to 8 weeks
the proportion of participants whose platelet count recovers to ≥ 80×10^9/L
Time Frame: Up to 14 days
Up to 14 days
the proportion of participants whose platelet count recovers to ≥ 100×10^9/L
Time Frame: Up to 14 days
Up to 14 days
Time to first platelet count ≥ 80×10^9/L
Time Frame: Up to 3 weeks
Up to 3 weeks
Platelet counts at each visit
Time Frame: From randomization up to the end of Cycle 1 of on-study anti-tumor therapy (each cycle is 21 days)
From randomization up to the end of Cycle 1 of on-study anti-tumor therapy (each cycle is 21 days)
Proportion of participants receiving at least one platelet-raising rescue therapy
Time Frame: From randomization up to the end of Cycle 1 of on-study anti-tumor therapy (each cycle is 21 days)
From randomization up to the end of Cycle 1 of on-study anti-tumor therapy (each cycle is 21 days)
Bleeding events
Time Frame: From randomization up to the end of Cycle 1 of on-study anti-tumor therapy (each cycle is 21 days)
From randomization up to the end of Cycle 1 of on-study anti-tumor therapy (each cycle is 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital of Zhengzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-KY-1560

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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