A Multicenter Clinical Controlled Study of Anlotinib Combined With PD-1 Antibody on Unresectable High-grade Chondrosarcoma With Different IDH Genotypes
There is no standard treatment for chondrosarcoma. Some small sample of studies has shown that anti-angiogenic TKIs show certain activity in the treatment of chondrosarcoma. PD-1 inhibitors, in recent years, have also been used in clinical practice and showed good efficacy. We intend to explore the response of chondrosarcoma to PD-1 monoclonal antibody and the influence of different IDH genotypes on PD-1 monoclonal antibody response.
• 1\. Age ≥18 years old, no gender limit; 2. ECOG PS score 0-2 points; 3. unresectable locally advanced or metastatic chondrosarcoma confirmed by histopathology, including high-grade (grade II-III) conventional CS and dedifferentiated CS; 4. Allow previous surgery, radiotherapy, or chemotherapy therapies; 5. Have at least 1 measurable lesion in accordance with the RECIST1.1; 6. The main organs are functioning normally and meet the following criteria within 7 days before treatment:
⁃ The standard of routine blood examination must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors):
∙ Hemoglobin (HB) ≥90g/L;
‣ The absolute value of neutrophils (ANC) ≥ 1.5×109/L;
‣ Platelets (PLT) ≥100×109/L ② The biochemical inspection shall meet the following standards:
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∙ Total bilirubin (TBIL)≤1.5×upper limit of normal (ULN);
‣ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN, if there is liver metastasis, ALT and AST ≤ 5×ULN;
‣ Serum creatinine (Cr)≤1.5×ULN or creatinine clearance (CCr)≥60ml/min;
∙ ③ Urine protein \<2+, and 24h urine protein quantitatively shows that the protein must be ≤ 1g;
∙ ④ Coagulation function: INR \<2.0 and APTT≤1.5×ULN
∙ ⑤ Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (60%)
∙ ⑥ Thyroid function: TSH ≤ upper limit of normal (ULN); if abnormal, T3 and T4 levels should be considered, and T3 and T4 levels are normal and can be included in the group; 9. The fertile male or female agrees to use reliable contraceptive methods during treatment and at least 12 months after the last study drug is taken; 10. Sign the informed consent form with my consent, have good compliance and cooperate with follow-up.