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 study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Micancer Center S.L.P.	Barcelona	Spain
Pratia Hematologia Sp. z o.o.	Katowice	Poland
Pratia S.A.	Skorzewo	Poland
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Multispecialty hospital for active treatment Sveta Sofia EOOD	Sofia	Bulgaria
Specialized Hospital For Active Treatment Of Oncology Haskovo EOOD	Haskovo	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Recruiting	16.02.2026
France	Not yet recruiting	16.02.2026
Poland	Not yet recruiting	16.02.2026
Romania	Recruiting	16.02.2026
Spain	Recruiting	16.02.2026

Trial locations

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.

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 ID:

2025-524209-34-00

Protocol code:

SHR8735-303

NCT ID:

NCT07286032

Trial Phase:

Therapeutic confirmatory (Phase III)

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?