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

NCT ID: NCT03491371

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-01
• Study Completion Date: 2017-02-01

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.

Conditions

Efficacy; Toxicity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

osteosarcoma

all patients had been given apatinib alone

Group Type: EXPERIMENTAL

Methylsulfonic apatinib

Intervention Type: DRUG

Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

Ewing sarcoma

Some of patients had been given apatinib alone while some of them had been given apatinib+everolimus

Group Type: EXPERIMENTAL

Methylsulfonic apatinib

Intervention Type: DRUG

Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

soft tissue sarcoma

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.

Group Type: EXPERIMENTAL

Methylsulfonic apatinib

Intervention Type: DRUG

Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

Chondrosarcoma

Patients were given apatinib alone

Group Type: EXPERIMENTAL

Methylsulfonic apatinib

Intervention Type: DRUG

Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

Interventions

Methylsulfonic apatinib

Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.

Intervention Type: DRUG

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Shougang Hospital

OTHER

Sponsor Role: collaborator

Peking University International Hospital

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Musculoskeletal Tumor Center of Peking University People's Hospital

Beijing, , China

Peking University Shougang Hospital

Beijing, , China

Countries

China

Other Identifiers

PKUPH-sarcoma 01

Identifier Type: -

Identifier Source: org_study_id