NCT04223583

Study on the Treatment of Soft Tissue Sarcoma With First-line Chemotherapy Failure by Anrotenil Hydrochloride Capsule

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Soft tissue sarcoma STS is a group of malignant tumors derived from connective tissue other than bone and cartilage. It can occur in any part of the body at any age, and there is no significant gender difference.According to pathological classification, STS has 19 tissue types and more than 50 disease subtypes.Currently, surgical resection, radiotherapy and drug therapy are the main treatment methods.But about 50% of the patients with distant metastasis happened not the surgical removal of, quite a number of in patients with distant metastasis after died of disease progression 8-12 months in drug treatment of soft tissue sarcoma, the current widely used chemotherapy regimens for ADM/IFO single-agent or joint IFO ADM is a line of chemotherapy, in addition, paclitaxel, gemcitabine, dorsey race, it was also used for soft tissue sarcomas of second-line chemotherapy scheme, however, for some special subtypes of sarcoma,Such as myxoid liposarcoma, pleomorphic rhabdomyosarcoma, leiomyosarcoma, glandular soft tissue sarcoma and superficial malignant fibrous histiocytoma, are not sensitive to chemotherapy or low sensitivity.Therefore, how to improve the survival rate of these patients is an urgent problem to be solved. Anlootinib hydrochloride is a multi-target tyrosine kinase inhibitor that has shown good efficacy in solid tumors such as NSCLC, ovarian cancer, soft tissue tumors, and medullary thyroid cancer.Especially in the field of soft tissue sarcomas, the results of phase IIb clinical data were satisfactory.Therefore, Investigator plan to conduct the study of anrotenil hydrochloride capsule for the treatment of soft tissue sarcomas with first-line chemotherapy failure (anthracycline)

Conditions

• Soft Tissue Sarcomas

Interventions

Type	Name	Description
DRUG	Anlotinib Hydrochloride	The standard first-line chemotherapy regimen (adriamycin + ifosfamide) failed

Timeline

• Start date: 2019-06-26
• Primary completion: 2021-01-31
• Completion: 2021-04-30
• First posted: 2020-01-10
• Last updated: 2022-03-16

Locations

1 site across 1 country: China