Well-Differentiated or Dedifferentiated Liposarcoma
Conditions
Interventions
Experimental group: Dalpiciclib
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. ECOG/PS 0-1; 3. Advanced Well-Differentiated or Dedifferentiated liposarcoma diagnosed by pathology and imaging; 4. CDK4-Amplifified confirmed by FISH and RB positive confirmed by IH; 5. Treatment-Naiveor failed to previous treatment within 6 months (according to RECIST 1.1); 6. According to RECIST version 1.1 , there is at least one measurable target lesion; 7. The expected survival time exceeds 3 months; 8. Sufficient organ and bone marrow function: (1) Hb >= 90 g/L(without blood transfusion within 14 days); (2) Neutrophil >= 1.5x10^9/L; (3) PLT >= 90x10^9/L; (4) Serum total bilirubin = 50% QTc in male, < 450 ms in female < 470 ms; 9. In untreated patients: INR <= 1.5, APTT<= 1.5 ULN; In patients receiving full or parenteral anticoagulants: Stable anticoagulant dose for at least 2 weeks and results of the coagulation test within the limits; 10. Women-of-childbearing-age are willing to use appropriate methods of contraception during the treatment and 3 months after the last experimental dose. Women-of-childbearing-age should have a pregnancy test before treatment (within 14 days). The result should be negtive. Men are willing to use appropriate methods of contraception during the treatment and 3 months weeks after the last experimental dose or have experienced surgically sterilized; 11. Recovery from previous treatment: All side effects subsided to grade 1 or less according to NCI-CTCAE version 5.0; If there is surgery, the wound has been completely healed; 12.Informed consent (or legal agent) should be signed to demonstrate their knowledge of the purpose and the operation required and show their willingness to participate in the study.
Exclusion criteria
Exclusion criteria: 1.vPatients who have ever accepted CDK4/6 inhibitors; 2. Patients who have ever accepted following treatment or drugs: (1) Surgery within 28 days before first dose (tissue biopsy for diagnosis is allowed); (2) Live-attenuated vaccine vaccination within 28 days prior to the first dose, or if planned vaccination during the study period and within 60 days after the completion of the last dose; (3) Any following treatment within 4 weeks prior to the first dose: radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, etc.; or participated in another interventional clinical trial; patients treated with other drugs within no more than 4 weeks from the last dose or 5 half-life of the drug; 3. Patients with uncontrolled cardiac diseases, such as (1) heart failure of NYHA II or above; (2) unstable angina; (3) myocardial infarction within 1 year; (4) patients with clinical meaningful supraventricular or ventricular arrhythmias; 4. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as positive hepatitis BV surface antigen [HBsAg], HBV-DNA >= 500 IU/ml and abnormal liver function; hepatitis C, defined as positive hepatitis C antibody (HCV-Ab), HCV-RNA and abnormal liver function), or combined hepatitis B and hepatitis C co-infection; 5. Severe infection within 2 weeks before the first dose (e.g., requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever> 38.5 centigrade during the screening period/before the first dose; 6. Arterial/venous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; 7. Suffering from other malignancies within recent 5 years, (except for cured skin basal cell carcinoma and cervical carcinoma in situ and ovarian carcinoma); 8. Those known to be allergic to any test drug or its excipients; 9. Pregnancy and lactation patients, reproductive patients are unwilling to take effective contraceptive measures; 10. There was a clear past history of neurological or psychiatric disorders, including epilepsy and dementia; 11. Patients who cannot swallow study drugs, resulting from chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn's disease, ulcerative colitis) and intestinal obstruction and other factors affecting drug taking and absorption; 12. Other conditions not suitable for inclusion. Family or social factors, will affect the safety of subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12 weeks Progression Free Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Progression Free Survival;Overall Survival;Clinical Benefit Rate;Duration of Response;Safety; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed