A Multicenter Clinical Controlled Study of Anlotinib Combined With PD-1 Antibody on Unresectable High-grade Chondrosarcoma With Different IDH Genotypes

Who is this study for? Patients with Chondrosarcoma
What treatments are being studied? Anlotinib Hydrochloride
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Zhaoming Ye, Medical PhD
yezhaoming@zju.edu.cn
86-0571-87783777
Time Frame
Start Date: 2023-02-06
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 70
Treatments
Experimental: Anlotinib combined with PD-1 monoclonal antibody
Anlotinib, a multi-target tyrosine kinase inhibitor,oral,12mg/10mg/8mg,2 weeks on and 1 week off; PD-1 monoclonal antibody,PD-1 inhibitor,Intravenous injection,once 3 week.
Active_comparator: Anlotinib monotherapy
Anlotinib, a multi-target tyrosine kinase inhibitor,oral,12mg/10mg/8mg,2 weeks on and 1 week off.
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov

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