Sarcoma
Conditions
Interventions
treatment-1:Dalpiciclib 100mg once daily oral d1-21+Apatinib 250mg once daily oral d1-28, every 28 days as one cycle
treatment-2:Dalpiciclib 100mg once daily oral d1-21+Apatinib 500mg once daily oral d1-28, every 28 days as one cycle
treatment-3:Dalpiciclib 150mg once daily oral d1-21+Apatinib 500mg once daily oral d1-28, every 28 days as one cycle
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18~80 years old; 2. Pathologically diagnosed as Sarcoma; 3. Patients who have undergone frontline systemic treatment but have failed, have distant metastasis or cannot be completely surgically resected based on imaging measurements; 4. Patients who have measurable or evaluable lesions (according to RECIST V1.1); 5. Patients who have not received CDK4/6 inhibitor treatment in the past; 6. Any CDK4/6 status; Tumor tissue genetic testing at baseline are recommended; 7. ECOG score 0-2 points; 8. Expected survival time = 3 months; Patients who have systemic treatment indications and no contraindications; 9. Patients are able to understand and sign the informed consent form (if the patient is unable to sign, shall be signed by his/her legal representative); 10. The main organs are functioning normally, without severe abnormalities in blood, heart, lungs, liver, kidneys, bone marrow, and other functions. The laboratory inspection meets the following requirements: a Hemoglobin (Hb) = 90g/L; b. White blood cells (WBC) = 3.0 × 10(9)/L; Neutrophil count (NEUT) = 1.5 × 10(9)/L; c. Platelet count (PLT) = 75 × 10(9)/L; d. Serum creatinine (SCr) = 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate = 50 ml/min (Cockcroft Fault formula); e. Total bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); f. AST/ALT levels = 2.5 times the upper limit of normal value (ULN); Patients with liver metastasis, AST/ALT levels = 5 times ULN; g. Urinary protein<2+; If the urine protein is = 2+, the 24-hour urine protein quantitative display must be = 1g; 11. Normal coagulation function, no active bleeding or thrombosis disease: a. International standardized ratio INR = 1.5 × ULN; b. Partial thromboplastin time APTT = 1.5 × ULN; c. Prothrombin time PT = 1.5 × ULN; 12. It is need to agree to take sufficient contraceptive measures within at least 6 months after enrollment and termination of treatment to avoid pregnancy;
Exclusion criteria
Exclusion criteria: 1. Pregnant, lactating, or childbearing women and their spouses refuse to use effective contraceptive methods for contraception; 2. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 3. Patients who have received long-term systemic steroid therapy (note: short-term users who have stopped medication for more than 2 weeks can be selected); 4. Patients with any hematological malignancy, including but not limited to leukemia (any form), lymphoma, and multiple myeloma; Note: Patients with cured malignant tumors of the blood or lymphatic system and who have not received corresponding anti-tumor treatment within 3 years may be included in the study based on the individual condition of the patient. 5. Patients with peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders; 6. Severe infection (such as requiring intravenous drip of antibiotics, antifungal or antiviral drugs) occurring within 4 weeks before the first medication, or unexplained fever (body temperature = 38.5 ° C) occurring during the screening period/before the first medication; 7. Accompanied by difficulty swallowing, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding, and perforation; Within 3 months, there have been significant clinical bleeding symptoms or clear bleeding tendencies, such as gastrointestinal bleeding, esophageal and gastric varices at risk of bleeding, hemorrhagic gastric ulcers, or vasculitis; Has experienced gastrointestinal perforation or fistula within 6 months; 8. Patients who have received or are currently receiving additional chemotherapy, radiation therapy, targeted or immunotherapy; 9. Patients with hypertension who cannot be reduced to the normal range after treatment with antihypertensive drugs (systolic blood pressure = 140 mmHg/diastolic blood pressure = 90 mmHg); 10. Patients who are suffering from uncontrollable clinical symptoms or diseases of the heart, such as (1) NYHA II and above heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, (4) poorly controlled arrhythmia; 11. Severe liver disease (such as cirrhosis), kidney disease, respiratory disease or chronic system diseases such as uncontrollable diabetes and hypertension 12. Patients who are suffering from active pulmonary tuberculosis; 13. Patients with brain metastasis; 14. Patients with a known history of allergies to the drug components of this protocol; 15. There may be an increased risk of participating in research and drug use, or other severe, acute, and chronic diseases; 16. Other situations that the researcher deems unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose limiting toxicity,DLT;Maximum Tolerated Dose, MTD;Recommended Phase 2 Dose, RP2D;Safety: Occurrence of DLT during the DLT observation period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Disease control rate,DCR;Duration of Response,DoR;Progressive Free Survival,PFS; | — |
Countries
China
Contacts
Public ContactBaoshan Cao
Peking University Third Hospital
Outcome results
None listed