Actively Recruiting
Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy
Led by Sir Run Run Shaw Hospital · Updated on 2024-05-30
50
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Hetrombopag for the Thrombocytopenia Induced by Concurrent Chemoradiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosed with malignant tumor by pathological or cytological examination
- Experiencing thrombocytopenia during simultaneous radiotherapy and chemotherapy
- Platelet count of 75 x 10^9/L or less on day of or within 3 days before enrollment
- Expected survival time of at least 12 weeks
- ECOG performance status score between 0 and 2
- Kidney function: creatinine less than or equal to 1.5 times upper normal limit, creatinine clearance rate at least 55 ml/min
- Liver function: total bilirubin no more than 1.5 times upper normal limit; ALT and AST no more than 3 times upper normal limit (exceptions for certain liver cancers)
- Women of childbearing age agree to use contraception during study and for 6 months after; not breastfeeding
- Male patients agree to contraception during study and for 6 months after
- No participation in other drug clinical trials within 4 weeks prior to enrollment
- Able to comply with follow-up for treatment effects and adverse reactions
- No serious complications like active gastrointestinal bleeding, perforation, jaundice, or fever above 38°C
- Able to understand the study and provide voluntary informed consent
You will not qualify if you...
- Thrombocytopenia caused by non-tumor treatments within past 6 months, including liver cirrhosis, splenic hyperfunction, infection, or bleeding
- Other blood diseases besides thrombocytopenia from concurrent chemoradiotherapy, such as leukemia, immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, or myelodysplastic syndrome
- Bone marrow invasion or metastasis
- Low hemoglobin (below 50 g/L) after red blood cell or erythropoietin treatment, or low neutrophils (below 1.0 x 10^9/L) after granulocyte colony-stimulating factor treatment
- Pelvic, spinal, or bone field radiation within 3 months before screening
- History of arterial or venous thrombosis within 6 months before screening
- Severe bleeding within 2 weeks before screening
- Platelet transfusion within 2 days before enrollment
- Severe cardiovascular disease or known arrhythmias increasing thrombosis risk within 6 months
- Treatment with thrombopoietin receptor agonists or related drugs within 14 days before screening
- Allergy or intolerance to hetrombopag or its excipients
- Breastfeeding women
- Vulnerable groups such as those with mental illness, cognitive impairment, critical illness, minors, or pregnant women
- Investigator’s judgment that participant is unsuitable for enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
Research Team
X
Xiaonan Sun
CONTACT
W
Weiwen Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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