Blood and Lymph Conditions

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Neoplasms

Digestive System Diseases

Thrombocytopenia

Gastrointestinal Neoplasms

Digestive System Neoplasms

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

Gastrointestinal Diseases

Hetrombopag Olamine 7.5mg orally, once a day, for 14 days. This product should be taken on an empty stomach, 2 hours after oral administration before eating, avoid taking it with meals.

Hetrombopag Olamine

xianglin Yuan, doctor

To evaluate the efficacy and safety of hetrombopag in the treatment of thrombocytopenia after chemotherapy in patients with digestive system malignant tumors

Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy

An Exploring Single Arm Study on the Efficacy and Safety of Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy in Malignant Tumors of the Digestive System

Days required for platelet recovery to ≥75×10\^9/ L

Measure of time from study enrollment until progression.

Huazhong University of Science and Technology

Chief physician

patients receive oral hetrombopag at an initial dose of 7.5 mg QD

The administration of hetrombopag as a monotherapy and at an initial dose of 7.5 mg QD.The dose adjusted based on platelet count.

Xiaonan Sun

Weiwen Zhou

Thrombocytopenia represents one of the main toxicities of concurrent chemoradiotherapy, which may necessitate chemotherapy dose reductions, dose delays, or discontinuation, and even compromise survival. Hetrombopag, a thrombopoietin receptor agonist, has shown efficacy and safety in patients with chemotherapy-induced thrombocytopenia. However, the efficacy of hetrombopag in patients who received concurrent chemoradiotherapy is not clear yet. This study aimed to evaluate the efficacy and safety of hetrombopag in this patient population.

Antitumor related therapy is one of the common causes of thrombocytopenia. Chemotherapy regimens based on drugs such as gemcitabine, platinum, anthracycline, and paclitaxel are high-risk options for thrombocytopenia. The degree of thrombocytopenia caused by external radiation therapy mainly depends on the irradiation dose, irradiation site, irradiation field size, and irradiation duration. The synchronous radiotherapy and chemotherapy regimen for head and neck tumors, esophageal cancer, rectal cancer, and other cancers often involves platinum drugs, and the irradiation site often involves flat and irregular bones. Therefore, the incidence of thrombocytopenia in patients during the treatment process is higher than that of chemotherapy or radiotherapy alone. In a phase III clinical study on the combination of carboplatin and paclitaxel in the treatment of esophageal cancer, the incidence of thrombocytopenia was as high as 54%. Once thrombocytopenia occurs, it may lead to a decrease in chemotherapy drug dosage, delay, and cessation of radiotherapy and chemotherapy, and may require platelet infusion. In follow-up studies of various cancer patients, it has been found that reducing the dosage of chemotherapy drugs or delaying the chemotherapy cycle will reduce treatment efficacy and lead to poor prognosis, including shortened disease-free survival (DFS) and overall survival (OS) time.

TPO-RA drugs are currently approved for indications in the fields of chronic primary immune thrombocytopenia (ITP), severe aplastic anemia (SAA), and chronic liver disease (CLD). There are also relevant data reports in the CIT field. A phase II clinical study using romiplostim for the treatment of CIT enrolled a total of 60 patients. After treatment with romiplostim, 85% of patients returned to normal platelet count within 3 weeks and resumed chemotherapy. In the subsequent prescribed chemotherapy cycle, only 6.8% of patients experienced a relapse due to another round of chemotherapy. The occurrence of CIT leads to a decrease or delay in chemotherapy dose; In another randomized placebo-controlled phase II study using eltrombopag for the prevention of solid tumor CIT, patients received gemcitabine monotherapy or gemcitabine combined with cisplatin/carboplatin regimen chemotherapy, and treated with eltrombopag or placebo 100mg before and 5 days after chemotherapy. In the 1-6 chemotherapy cycles, the average platelet count on the day before chemotherapy in the eltrombopag group was numerically higher than that in the placebo group, but did not reach statistically significant differences. The incidence of grade 3/4 thrombocytopenia in the eltrombopag group was lower than that in the placebo group. Among patients in the combination chemotherapy group, the average time required for eltrombopag group to recover from the lowest platelet count to normal was 8 days. The placebo group, on the other hand, requires 15 days, and the incidence of delayed/reduced chemotherapy dose or dose loss due to thrombocytopenia is lower in patients in the eltrombopag group, Therefore, in gemcitabine based chemotherapy, treatment with eltrombopag can shorten the time for platelet minimum recovery and reduce the delayed/reduced chemotherapy dose caused by thrombocytopenia. However, there is still a lack of stronger evidence-based medicine for the application of TPO-RA drugs in CIT, and there is no relevant data in the field of concurrent chemoradiotherapy induced thrombocytopenia.

Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy

A Single-arm, Phase II Trial of Hetrombopag for the Treatment of Concurrent Chemoradiotherapy-induced Thrombocytopenia in Patients With Advanced Solid Tumors

The response rate is defined as the proportion of patients who receive treatment with hetrombopag until PLT≥100×10\^9/L

Use Kaplan Meier method to estimate median platelet recovery time.

The number of events in which radiotherapy and chemotherapy were suspended due to thrombocytopenia, as determined by researchers

Researchers determine the number of platelet transfusion events caused by thrombocytopenia

Record the name and frequency of serious adverse events

Sir Run Run Shaw Hospital

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

The study in a 1:1 randomization ratio (36 subjects to experimental group). The treatment group received Herteppa Ethanolamine tablets and platelet transfusion.

The study in a 1:1 randomization ratio (36 subjects to control group). The control group did not receive other platelet raising therapy except platelet transfusion.

The subjects will initiate treatment with 7.5 mg hetrombopag once a day, starting orally 24 hours after the end of chemotherapy. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts once every two weeks, and maximum dose should not exceed 15 mg daily. Subjects whose platelet count \<25×109/L for 2 weeks, the hetrombopag dose will be increased by 2.5mg. If subjects whose platelet count ≥100×109/L or who had received hetrombopag for 28 days, hetrombopag can be stopped. Hetrombopag Olamine is sponsored by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Emergency treatment: When the platelet count was less than 20×109/L, platelet transfusion was given according to the evaluation of the investigator.

Yi Fang, MD.,Ph.D

Xiaofeng Han, MD.,Ph.D

Randomized, controlled, open study to evaluate the efficacy and safety of Hetrombopag in the treatment of chemotherapy-induced thrombocytopenia(CIT) in patients with acute myeloid leukemia

This study is a prospective, single center, randomized, controlled and open clinical trial initiated by the researchers to evaluate the efficacy and safety of Hetrombopag in the treatment of thrombocytopenia caused by chemotherapy in acute myeloid leukemia. The study focuses on acute myeloid leukemia patients aged 18-70 who have completed induction chemotherapy and achieved complete remission, and have received ≤ 1 course of intensive therapy for consolidation. Patients were randomly divided into the treatment group and the control group through the random number table by 1:1. The treatment group received Hetrombopag and platelet transfusion, and the control group did not receive other platelet raising therapy except platelet transfusion. The study used the proportion of subjects with effective treatment during the randomized treatment period as the main efficacy indicator. 72 patients are planned to be enrolled, with treatment group and control group=1:1.

Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia

A Randomized, Controlled Study on the Efficacy and Safety of Hetrombopag in the Treatment of Chemotherapy-induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy	NCT05575986	Malignant Tumor... Trombocitopenia	Hetrombopag Ola...	18 Years -	Huazhong University of Science and Technology
Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy	NCT06433830	Thrombocytopeni... Radiotherapy Si...	Hetrombopag Ola...	18 Years -	Sir Run Run Shaw Hospital
Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia	NCT05944211	Chemotherapy-In...	Hetrombopag Ola...	18 Years - 70 Years	RenJi Hospital
Herombopag Olamine in the Treatment of Thrombocytopenia After Chemotherapy	NCT05575986	Malignant Tumor... Trombocitopenia	Hetrombopag Ola...	18 Years -	Huazhong University of Science and Technology

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