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A study to evaluate the effectiveness and safety of efaglomograstim alfa in patients with low blood platelet counts caused by chemotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being conducted to evaluate the effectiveness and safety of a medication called hetrombopag olamine for treating chemotherapy-induced thrombocytopenia. This condition refers to a low number of platelets, which are the cells in the blood responsible for helping it clot, occurring after a patient receives chemotherapy. Patients in the study may receive either hetrombopag olamine in the form of a film coated tablet or a placebo.

The research involves two parts. The first part focuses on pharmacokinetics, which is the study of how a drug moves through the body. The second part focuses on how well the treatment works to increase the blood cell count. During the study, the amount of the drug in the blood and the ability to complete cycles of cancer treatment without needing to change the doses of other medications will be observed.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Participation in the study

    After joining the study, a period of treatment begins to address low blood platelet counts (thrombocytopenia) caused by chemotherapy.

    The treatment involves taking either hetrombopag olamine tablets or a placebo, which is a tablet that looks like the medicine but contains no active ingredients.

  2. Step 2

    Medication administration

    If assigned to the test group, hetrombopag olamine is taken by mouth as a film coated tablet.

    The specific dosage for the hetrombopag olamine will be determined according to the study protocol.

  3. Step 3

    Monitoring and evaluation

    During the treatment, blood platelet counts are monitored to see if they reach a level of 100x109 /L within 14 days of starting the medicine.

    The progress is tracked through two consecutive cycles of chemotherapy.

    The goal is to complete these chemotherapy cycles without needing to change the dose of myelosuppressive agents (medicines that affect bone marrow function) due to low platelets.

    It is necessary to avoid rescue therapy (additional medical treatment to quickly raise platelet levels) from the start of the medication until day 21 of the second chemotherapy cycle.

Who can join the trial?

8 criteria

  • You must be a male or female who is 18 years of age or older at the time of the initial screening.
  • You must have a confirmed solid tumor, which is a type of cancer that forms a mass or lump in the body's tissues. This is confirmed through histology (looking at tissue samples under a microscope) or cytology (looking at individual cells under a microscope).
  • You must be undergoing chemotherapy, a type of cancer treatment, using specific drugs called platinum or gemcitabine on a schedule that repeats every 21 days.
  • Your platelet count, which is the number of cells in your blood that help with clotting, must be less than 75×10⁹/L.
  • For the second part of the study, you must have had a treatment delay of 7 days or more in your chemotherapy cycle because your platelet count was too low due to chemotherapy-induced thrombocytopenia (a condition where chemotherapy causes a low number of platelets in the blood).
  • Your ECOG performance status, which is a scale used by doctors to measure how well you can perform daily activities, must be between 0 and 2.
  • You must have adequate organ and hematologic function, meaning your organs (like your heart, liver, or kidneys) and your blood components (like red and white blood cells) are working well.
  • For the first part of the study, you must be of a non-Asian race or ethnicity.

Who cannot join the trial?

9 criteria

  • Having a platelet count (a type of blood cell that helps with clotting) that is lower than 25×10⁹/L during the initial screening process.
  • Having hematopoietic diseases, which are disorders affecting the production of blood cells, other than chemotherapy-induced thrombocytopenia (a low platelet count caused by cancer treatment).
  • Having primary immune thrombocytopenia, a condition where the body's immune system attacks and destroys its own platelets.
  • Having hematologic malignancies, which are cancers that affect the blood or the blood-forming tissues like the bone marrow.
  • Having brain metastases, which are areas of cancer that have spread to the brain, that have not been treated.
  • Having leptomeningeal metastasis, which is a type of cancer spread that affects the protective membranes covering the brain and spinal cord.
  • Having bone marrow involvement or bone marrow metastasis, meaning cancer cells have spread to the soft tissue inside the bones where blood cells are made.
  • Having experienced arterial or venous thrombosis, which is the formation of a blood clot inside an artery or a vein, within 6 months before the first day of the study.
  • Having experienced severe hemorrhage, which is heavy or uncontrolled bleeding, such as in the stomach and intestines (gastrointestinal) or inside the skull (intracranial), within 28 days before the first day of the study.
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Investigated drugs

Hetrombopag olamine is a medication taken by mouth that is being studied to see if it can help increase blood platelet counts in patients whose platelet levels have become too low due to chemotherapy treatments.

What is already known about the treatment

  • Placebo tablets

    These are inactive pills that look and feel exactly like the actual medication being tested. They contain no active ingredients and are taken by mouth to serve as a comparison during the study. This allows researchers to determine if the effects seen in patients are truly caused by the test drug rather than other factors.

  • Hetrombopag Olamine

    This medication is taken as a film-coated tablet by mouth to help increase platelet counts in patients whose blood cells have been lowered by chemotherapy. It is currently being studied in late-stage clinical trials to determine its effectiveness for this specific use. It works by binding to a specific receptor on the surface of cells to trigger the body's natural process for producing more platelets. This drug belongs to a class of medicines known as thrombopoietin receptor agonists.

Investigated diseases

Chemotherapy-induced thrombocytopenia - This condition occurs when a patient receives chemotherapy to treat cancer. The medication used for cancer treatment can temporarily damage the bone marrow, which is the area responsible for producing blood cells. As a result, the body produces fewer platelets, which are the small cells that help blood clot. This leads to a decrease in the total number of platelets circulating in the bloodstream. The condition typically develops during or shortly after the administration of chemotherapy cycles.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524209-34-00Protocol codeSHR8735-303Estimated enrolment121 patientsSponsorJiangsu Hengrui Pharmaceuticals Co. Ltd.

sourced from the EU Clinical Trials Register and site verification

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