Apatinib for Advanced Sarcoma: Results From Multiple Institutions' Off-label Use

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborators: Peking University International Hospital; Peking University Shougang Hospital
• Treatments: Apatinib

Criteria

Inclusion Criteria:

• 1) histologically confirmed high-grade sarcoma;

• 2) initial treatment in the orthopedic oncology departments of the three 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) [8];

• 6) Eastern Cooperative Oncology Group performance status 0 or 1 [9]; and 7) acceptable hematologic, hepatic, and renal function.

Exclusion Criteria:

• had been previously exposed to other TKIs;

• 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

• were pregnant or breastfeeding.