Apatinib for Inoperable Advanced Chondrosarcoma

Not Applicable

Completed

• Conditions: Efficacy; Toxicity, Drug
• Interventions: Drug: Apatinib Mesylate

• Registration Number: NCT04260113
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Anti-angiogenesis Tyrosine kinase inhibitors (TKIs) have been proved to show promising effects on prolonging progression-free survival (PFS) for advanced chondrosarcoma after failure of standard multimodal Therapy. Methylsulfonic apatinib is one of those TKIs which specifically inhibits VEGFR-2. This study summarizes the experience of two Peking University affiliated hospitals in off-label use of apatinib in the treatment of extensively pre-treated chondrosarcoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-01-01
• Study First Submitted: 2020-02-05
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-07
• Study Completion: 2020-04-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-02
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1. histologically confirmed high-grade sarcoma;
• 2. initial treatment in the orthopedic oncology departments of the two affiliated hospitals of Peking University;
• 3. tumors not amenable to curative treatment or inclusion in clinical trials;
• 4. unresectable local advanced lesions or multiple metastatic lesions that could not be cured by local therapy;
• 5. measurable lesions according to Response Evaluation Criteria for Solid Tumors (RECIST1.1) ;
• 6. Eastern Cooperative Oncology Group performance status 0 or 1;
• 7. acceptable hematologic, hepatic, and renal function.

Exclusion Criteria

• had central nervous system metastasis;
• had other kinds of malignant tumors at the same time; had cardiac insufficiency or arrhythmia;
• had uncontrolled complications such as diabetes mellitus, coagulation disorders, urine protein ≥ ++ and so on;
• had pleural or peritoneal effusion that needs to be handled by surgical treatment;
• combined with other infections or wounds;
• pregnant or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apatinib Arm	Apatinib Mesylate	-

Primary Outcome Measures

Name	Time	Method
progression-free survival	6 months	from initial treatment to date of recorded progression or death or last follow-up

Secondary Outcome Measures

Name	Time	Method
objective response rate	6 months	CR+PR according to RECIST 1.1
overall survival	5 years	from initial treatment to death or last follow-up
clinical benefit rate	6 months	CR+PR+SD according to RECIST 1.1

Trial Locations

Locations (2)

Musculoskeletal Tumor Center of Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Peking Univresity Shougang Hospital; 🇨🇳 Beijing, Beijing, China