Refractory cancer treatment-induced Thrombocytopenia
Conditions
Interventions
Intervention group:All-Trans Retinoic Acid Combined with Decitabine
Sponsors
Henan Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years (inclusive of both endpoints); 2.Weight>=45 kg at screening; 3.Patients with histological or cytological confirmation of colorectal cancer, pancreatic cancer, liver cancer, etc. (digestive tract tumors), or ovarian cancer, cervical cancer, endometrial cancer, etc. (gynecological tumors), who have achieved a complete response, partial response, or stable disease in their primary disease as assessed by RECIST 1.1 (see Appendix 1) after chemotherapy, targeted therapy, or immunotherapy; 4.Thrombocytopenia of tumor origin is confirmed by peripheral blood smear and bone marrow examination, with no diagnosis of bone marrow metastasis, hemophagocytic syndrome, disseminated intravascular coagulation, or other causes of thrombocytopenia; 5.Platelet count=6 months; 11.Females of childbearing potential and males with fertile partners must agree to use effective contraception during the trial and for at least 1 year after the last dose of study drug; 12.Able and willing to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or breastfeeding women; 2.Those allergic to components of the study drug or excipients; 3.Patients with uncontrolled severe infection; 4.Those who received radiotherapy within 3 months prior to enrollment; 5.Patients with a history of pulmonary arterial embolism or myocardial infarction, or a history of thrombosis or mobile thrombosis within the last 3 months (excluding intramuscular venous thrombosis and controlled catheter - related thrombosis); 6.Those who experienced severe bleeding within 4 weeks prior to screening; 7.Patients with sepsis, disseminated intravascular coagulation (DIC), splenomegaly, or any other condition that may exacerbate thrombocytopenia during past chemotherapy cycles; 8.Patients with central nervous system (CNS) metastases, bone marrow metastases, or bone metastases; 9.Patients with severe skin diseases that do not respond well to local treatment; 10.Those who received COVID - 19 vaccine, live - virus vaccine, or inactivated - virus vaccine within 1 month prior to screening or during the screening period; 11.Patients with a known positive test result for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); 12.Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] during the screening period and HBV - DNA levels above the normal upper limit of the clinical laboratory of the research center); active hepatitis C (defined as positive hepatitis C surface antibody [HCSAb] and HCV - RNA during the screening period); 13.Other conditions deemed unsuitable for participation in the trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time when the platelet count reached >75×10^9/L and >=100×10^9/L, respectively;The proportion of patients whose platelet counts reach >75×10?/L and =100×10?/L respectively.;The proportion of patients who did not receive platelet transfusions.;The proportion of patients without clinically relevant bleeding.;The lowest platelet count.;The proportion of patients who did not receive salvage therapy.;Cycles with successful completion of the subsequent treatment cycle for the primary tumor;The proportion of patients who did not receive platelet transfusions.;Average duration of extension of tumor treatment cycles due to thrombocytopenia;Adverse event incidence rate; | — |
Countries
China
Contacts
Public ContactHu Zhou
Henan Provincial Cancer Hospital
Outcome results
None listed