Overview

Avatrombopag for Chemotherapy-induced Thrombocytopenia

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the efficacy and safety of Avatrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital
Collaborators:
Henan Cancer Hospital
The Second Affiliated Hospital of Kunming Medical University
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Second Hospital
Tianjin People's Hospital
Tianjin Third Central Hospital
Criteria
Inclusion Criteria:

- Aged ≥18 years old, male or female;

- Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT);
Ineffective after repeated treatment with rhTPO or IL-11;

- Stop radiotherapy or chemotherapy for more than 1 month;

- Platelet counts <30 ×10^9/L, and bleeding tendency;

- Estimated survival period ≥ 6 months;

- People who are willing to sign the informed consent voluntarily and follow the
research program.

- Liver and kidney function<1.5×upper limit of normal, qualified for physical
examination;

- Subject is practicing an acceptable method of contraception. Women of childbearing
potential must have a negative serum pregnancy test in the whole study;

Exclusion Criteria:

- Those with uncontrollable primary diseases of important organs, such as extensive
metastasis of malignant tumors, liver failure, heart failure, kidney failure and other
diseases;

- Patients with poor compliance;

- Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or
hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA,
Cytomegalovirus DNA;

- Accompanied by extensive and severe bleeding, such as hemoptysis, upper
gastrointestinal bleeding, intracranial hemorrhage, etc.

- There is currently a heart disease requiring treatment or a poorly controlled
hypertension judged by the investigator;

- Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and
atherosclerosis;

- Those who have received allogeneic stem cell transplantation or organ transplantation
in the past;

- Patients with mental disorders who cannot normally obtain informed consent and undergo
trials and follow-up;

- Patients whose toxic symptoms caused by treatment before participating in the trial
have not disappeared;

- Other serious diseases that may restrict participants from participating in this trial
(such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia
or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases,
etc.);

- Patients with sepsis or patients with other irregular bleeding;

- Patients taking antiplatelet drugs at the same time;

- Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic
gonadotropin in urine at screening) and breastfeeding patients;

- Pre-existing cardiac disease, including congestive heart failure of New York Heart
Association [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardial
infarction within the last 6 months. No arrhythmia known to increase the risk of
thrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc >
480 for patients with a Bundle Branch Block;

- Researchers believe that patients should not participate in the test of any other
condition.