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

Not Applicable

Completed

• Conditions: Efficacy; Toxicity
• Interventions: Drug: Methylsulfonic apatinib

• Registration Number: NCT03491371
• 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 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.

Detailed Description

The investigators retrospectively analysed files of patients with advanced sarcoma not amenable to curative treatment, who were receiving an apatinib-containing regimen between June 1, 2015 and December 1, 2016. Fifty-six patients were included: 22 osteosarcoma, 10 Ewing's sarcoma, 3 chondrosarcoma and 21 soft tissue sarcoma.

Study Timeline

• Study Start: 2015-06-01
• Primary Completion: 2016-12-31
• Study Completion: 2017-02-01
• Study First Submitted: 2018-03-31
• Study First Submitted QC: 2018-03-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-06
• Study First Posted: 2018-04-09
• Last Update Posted: 2018-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ewing sarcoma	Methylsulfonic apatinib	Some of patients had been given apatinib alone while some of them had been given apatinib+everolimus
osteosarcoma	Methylsulfonic apatinib	all patients had been given apatinib alone
soft tissue sarcoma	Methylsulfonic apatinib	Some of the patients had been given apatinib alone while some of the patients had been given apatinib together with GT chemotherapy, which was gemcitabine 1000 mg/m2 d1,8 and docetaxel 75 mg/m2 d8 once every 21 day.
Chondrosarcoma	Methylsulfonic apatinib	Patients were given apatinib alone

Primary Outcome Measures

Name	Time	Method
objective response rate	3 month	CR+PR accroding to RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Overall Survival,OS	12 months	OS was defined as time from the start of using apatinib until death.
progression-free survival, PFS	4 months and 6 months	PFS was defined as time from the start of using apatinib until disease progression or death, whichever occurred first.
duration of response, DOR	4 months	The time from appearance of response or stable disease to progression or death was thus considered the DOR
toxicity	12 months	accroding to the Common Terminology Criteria for Adverse Events 4.0

Trial Locations

Locations (2)

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

Peking University Shougang Hospital; 🇨🇳 Beijing, China