NCT05193188

A Study of Anlotinib Combined With or Without PD-1 Antibody on Unresectable High-grade Chondrosarcoma

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chondrosarcoma

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride	Anlotinib 12mg per person per day, continuous medication for 2 weeks and 1 week off, 3 weeks 1 cycle, until disease progression or intolerable toxicity
DRUG	PD-1 inhibitor	Intravenous injection, once every 3 weeks, until the disease progression or intolerable toxicity

Timeline

• Start date: 2023-02-06
• Primary completion: 2025-03-31
• Completion: 2026-03-31
• First posted: 2022-01-14
• Last updated: 2023-02-16

Locations

1 site across 1 country: China