A Single-center, Prospective, Single-arm Phase Ib/II Clinical Study on the Efficacy and Safety of Fluzoparib Combined With Dalpiciclib in the Treatment of Locally Advanced or Metastatic Sarcoma r
This is a single-center, single-arm phase Ib / II clinical trial, which was included with two phase. The main purpose of the phase Ib part was to determine the dose-limiting toxicity ( DLT ), maximum tolerated dose ( MTD ), and recommended dose ( RP2D ) of Fluzoparib combined with Dalpiciclib in patients with locally advanced or metastatic sarcoma. The phase II part is mainly to observe the efficacy and safety of Fluzoparib combined with Dalpiciclib.
• a)Blood examination : (without blood transfusion within 14 days before screening, without using granulocyte colony stimulating factor \[ G-CSF \], or other methods to correct bone marrow suppression within 7 days ) ,Blood indicators should meet: i.hemoglobin ≥ 90 g / L ; ii.neutrophil count ≥ 1.5 × 109 / L ; iii.Platelet count ≥ 75 × 109 / L ; b)b. Biochemical examination : ( no albumin transfusion within 14 days ) indicators should meet: i.albumin ≥ 29 g / L ; ii.Alanine aminotransferase ( ALT ) and aspartate aminotransferase ( AST ) ≤ 2.5 times the upper limit of normal ( ULN ) ; iii.total bilirubin ( TBIL ) ≤ 1.5 times ULN ; iv.Creatinine Cr ≤ 1.5 times ULN or Cr clearance \> 50 mL / min; v.Urine protein \< 2 +. If Urine protein ≥ 2 +, an 24 hours ( h ) urine protein quantification test should be taken, and 24h urine protein quantification \< 1.0 g is allowed to include ) ; c)Coagulation function : activated partial thromboplastin time ( APTT ) and international normalized ratio ( INR ) ≤ 1.5 × ULN ( for those who regularly use anticoagulant therapy such as low molecular weight heparin or warfarin and INR meets the expected requirement are allowed to include ) ; d)Thyroid stimulating hormone ( TSH ) ≤ ULN ; If not, T3 and T4 levels should be examined, and only with normal T3 and T4 level is allowed to include.
• e)Echocardiography : left ventricular ejection fraction ( LVEF ) ≥ 60 %. 6.Non-surgical sterilization or women of childbearing age who are required to use a medically approved contraceptive (such as an intrauterine device, contraceptive pill or condom) during the study treatment period and for 6 months after the study treatment period ends; Female patients of childbearing age who were not surgically sterilized must have a negative serum or urine HCG test within 7 days prior to study enrollment; And must be non-lactation period; For male patients with a partner of a woman of childbearing age, effective contraceptive methods should be used during the trial period and within 6 months after the last Fluzoparib or Dalpiciclib administration.
• Understand the research procedures and methods, volunteer to participate in the experiment, and sign the informed consent. And fully understand the trial content, process and possible adverse reactions.
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