A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia

July 13, 2026 updated by: Jiangsu HengRui Medicine Co., Ltd.

A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia

The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.
150

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 3

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.

Study Locations

  • United States
    • California
      • Los Alamitos, California, United States, 90254
        • Not yet recruiting
        • Cancer and Blood Specialty Clinic
        • Principal Investigator:
          • Arati Chand
    • Colorado
      • Denver, Colorado, United States, 80210
        • Not yet recruiting
        • AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology
        • Principal Investigator:
          • Yousuf Gaffar
    • Florida
      • Coral Springs, Florida, United States, 33065
        • Not yet recruiting
        • Oncology & Hematology Associates of West Broward
        • Principal Investigator:
          • Sumit Sawhney
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Mid-Florida Hematology & Oncology Centers, P.A.
        • Principal Investigator:
          • Santosh Nair
    • Illinois
      • Springfield, Illinois, United States, 62702
        • Not yet recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Preet Singh
    • New Jersey
      • Morristown, New Jersey, United States, 07039
        • Not yet recruiting
        • Morristown Medical Center
        • Principal Investigator:
          • Se young Han
    • New York
      • Shirley, New York, United States, 11967
        • Not yet recruiting
        • New York Cancer and Blood Specialists One Oncology
        • Principal Investigator:
          • Richard Zuniga

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female gender, age ≥18 years at screening.
  2. Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
  3. Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
  4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
  5. Life expectancy ≥6 months.
  6. Signed ICF for voluntary participation in the study and good compliance.

Exclusion Criteria:

  1. Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
  2. Hematologic malignancies.
  3. Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
  4. Untreated brain metastases; or with leptomeningeal metastasis.
  5. Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
  6. Severe cardiovascular disorders or interventions within 6 months
  7. Have arterial/venous thrombosis within 6 months
  8. Known bleeding disorders, platelet dysfunction
  9. Severe haemorrhage during screening
  10. Acute or uncontrolled hepatitis B&C infection
  11. Human immunodeficiency virus (HIV) infection.

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

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: Part A: Hetrombopag Olamine
Drug: Hetrombopag Olamine
For Part A, all participants would receive hetrombopag treatment.
Experimental: Part B：Hetrombopag Olamine vs Hetrombopag Olamine Placebo
Drug: Hetrombopag Olamine ；Hetrombopag Olamine Placebo
For Part B，participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。

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
Time Frame
Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.
Time Frame: around 6 months.
around 6 months.
Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months
Time Frame: around 6 months
around 6 months
Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months
Time Frame: around 6 months
around 6 months
Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years
Time Frame: around 3 years
around 3 years
Part B:No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until Cycle 2 Day 21, around 3 years.
Time Frame: around 3 years.
around 3 years.
Part B:Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years;
Time Frame: around 3 years;
around 3 years;

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
Proportion of participants achieving platelet count ≥100×109/L without the use of rescue therapy within 14 days after initiating the investigational product treatment,around 3 years;
Time Frame: around 3 years;
around 3 years;
platelet count nadir from Cycle 1 Day 1 until Cycle 2 Day 21, around 3 years;
Time Frame: around 3 years;
around 3 years;
Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until C2D21, around 3 years;
Time Frame: around 3 years;
around 3 years;
Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until Cycle 2 Day 21, around 3 years.
Time Frame: around 3 years.
around 3 years.
Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years.
Time Frame: around 3 years.
around 3 years.

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.
Jiangsu HengRui Medicine Co., Ltd.

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 (Actual)

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.
April 16, 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 1, 2028

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.
June 1, 2029

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).
December 10, 2025

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.
December 10, 2025

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.
December 16, 2025

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.
July 14, 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.
July 13, 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.
December 1, 2025

More Information

Terms related to this study

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.
  • SHR8735-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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