Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy

NCT06433830 | Recruiting Phase 2

• 1 other identifier: 20220125-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thrombocytopenia; Radiotherapy Side Effect

Keywords

hetrombopag; thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with PLT ≥100×10^9/L

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

  From admission to discharge, up to 6 weeks

Secondary Outcomes (4)

• The median time of PLT ≥100×10^9/L

  From admission to discharge, up to 6 weeks

• Incidence of delayed radiotherapy cycles due to thrombocytopenia

  From admission to discharge, up to 6 weeks

• Number and percentage of patients receiving platelets transfusion for thrombocytopenia

  From admission to discharge, up to 6 weeks

• Incidence of serious adverse events according to CTCAE 5.0 criteria

  From admission to the end of the study, up to 9 weeks

Study Arms (1)

Hetrombopag

EXPERIMENTAL

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

Drug: Hetrombopag Olamine

Interventions

Hetrombopag Olamine DRUG

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

Also known as: thrombopoietin receptor agonist

Hetrombopag

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Renal function: Cr ≤ ULN (upper limit of normal value) x 1.5, endogenous creatinine clearance rate (Ccr) ≥ 55 ml/min;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia; Radiation Injuries

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Wounds and Injuries

Study Officials

• Xiaonan Sun

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Weiwen Zhou

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaonan Sun

CONTACT

(+86)-0571-86006783; sunxiaonan@zju.edu.cn

Weiwen Zhou

CONTACT

(+86)-0571-86006783; 21718403@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 30, 2024
• Study Start: May 10, 2022
• Primary Completion: May 30, 2025
• Study Completion: July 30, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

CN (1)