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Brief Title: A Study of Anlotinib Combined With or Without PD-1 Antibody on Unresectable High-grade Chondrosarcoma
Official Title: A Multicenter Clinical Controlled Study of Anlotinib Combined With PD-1 Antibody on Unresectable High-grade Chondrosarcoma With Different IDH Genotypes
Study ID: NCT05193188
Brief 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.
Detailed Description: 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. Patients with unresectable locally advanced or metastatic chondrosarcomas(CS), including high-grade (II-III) ordinary CS and dedifferentiated CS, are qualified. The experimental group was PD-1 monoclonal antibody combined with Anlotinib for treatment of unresectable locally advanced or metastatic CS, and the control group was anlotinib monotherapy. The treatment is continuous until the disease progression or intolerable toxicity. CS with disease progression in the control group was allowed to enter the experimental group to continue treatment. The primary endpoint was 6-month PFSR.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Name: Binghao Li, Medical PhD
Affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
Role: PRINCIPAL_INVESTIGATOR