Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy

Launched by SIR RUN RUN SHAW HOSPITAL · May 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called hetrombopag to see if it can help patients who have low platelet counts, known as thrombocytopenia, due to treatment with both chemotherapy and radiation therapy. Low platelet counts can be a serious issue, as they may require doctors to reduce or delay treatment, which can affect the overall success of cancer treatment. The trial aims to find out if hetrombopag is safe and effective for these patients.

To participate in this study, individuals must be at least 18 years old and diagnosed with a cancer that is being treated with both chemotherapy and radiation. They should have a platelet count below a certain level and be in good enough health to participate. Participants can expect close monitoring throughout the trial to assess the medication's effects and any side effects. It's important to note that individuals with certain medical conditions or who have had specific treatments recently may not be eligible to join the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old, regardless of gender;
• • Malignant tumor patients diagnosed through pathological or cytological examination, regardless of cancer type, may experience thrombocytopenia during radical synchronous radiotherapy and chemotherapy treatment;
• • Platelet count of patients ≤ 75 × 10\^9/L on the day or 3 days prior to enrollment;
• • Expected survival time ≥ 12 weeks;
• • ECOG PS score for physical condition: 0-2 points;
• * The laboratory inspection indicators meet the following requirements:
• • 1. Renal function: Cr ≤ ULN (upper limit of normal value) x 1.5, endogenous creatinine clearance rate (Ccr) ≥ 55 ml/min;
• • 2. Liver function: Total bilirubin ≤ ULN × 1.5; ALT and AST ≤ ULN × 3; (If it is intrahepatic cholangiocarcinoma or liver metastasis, total bilirubin should not exceed 3 times the normal upper limit, and transaminase should not exceed 5 times the normal upper limit);
• • Women of childbearing age agree to use contraception during the study period and within 6 months after the end of the study; And not a lactating patient; Male patients who agree to contraception during the study period and within 6 months after the end of the study;
• • Those who have not participated in clinical trials of other drugs within the 4 weeks prior to enrollment;
• • It is expected that those with good compliance will be able to follow up on therapeutic effects and adverse reactions according to the protocol requirements;
• • No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal disorders Obstruction, non cancerous fever\>38 °C;
• • The subjects are able to understand the situation of this study and voluntarily sign an informed consent form.
• Exclusion Criteria:
• • Screening for thrombocytopenia caused by non tumor treatment within the first 6 months, including but not limited to liver cirrhosis, splenic hyper function, infection, and bleeding;
• • Suffering from other hematopoietic system diseases besides thrombocytopenia caused by concurrent radiotherapy and chemotherapy for malignant tumors, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
• • Combined bone marrow invasion or bone marrow metastasis;
• • After treatment with infusion of red blood cells or erythropoietin (EPO), hemoglobin remains below 50g/L, or after treatment with granulocyte colony-stimulating factor (G-CSF), the absolute value of neutrophils remains below 1.0 × 10\^9/L;
• • Have received pelvic and spinal radiation therapy, as well as bone field radiation, within the three months prior to screening;
• • History of arterial or venous thrombosis within the first 6 months of screening;
• • Clinical manifestations of severe bleeding (such as gastrointestinal bleeding) within the first two weeks of screening;
• • Received platelet transfusion within 2 days prior to enrollment;
• • Screening for patients with severe cardiovascular diseases (such as NYHA heart function score III-IV), known arrhythmias that increase the risk of thromboembolism, such as atrial fibrillation, coronary stent implantation, angioplasty, and coronary artery bypass grafting within the first 6 months;
• • Received treatment with recombinant human thrombopoietin (rhTPO), recombinant human interleukin-11 (rhIL-11), or thrombopoietin receptor agonists (such as eltrombopag, avatrombopag) within 14 days prior to screening;
• • Patients who are known or expected to be allergic or intolerant to the active ingredients or excipients of hetrombopag tablets (excipients include cellulose lactose, low substituted hydroxypropyl cellulose, magnesium stearate, and film coated premixes);
• • Breastfeeding women;
• • Vulnerable groups, including individuals with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, etc;
• • The researcher believes that the participants are not suitable for enrollment.