Advanced Cancer, Chordoma, Effect of Drugs, Quality of Life
Conditions
Keywords
chordoma, unresectable, anlotinib, imatinib, survival, quality of life
Brief summary
For local relapse not amenable to reasonable curative surgery or for those with metastatic chordoma, chemotherapy is recognised as inactive. The major study drug is the small molecular tyrosine kinase inhibitors targeted at the stem cell factor receptor (KIT) and the platelet-derived growth factor receptors (PDGFRA and PDGFRB), eg. imatinib. Anlotinib is a novel tyrosine kinase inhibitor targeting both at VEGFR-2, -3 and PDGFRA and PDGFRB with high affinity, which also showed broad antitumor activity against EGFR and so on. Thus this multicenter, two-armed phase II trial of PKUPH-sarcoma 05 intended to investigate the efficacy and safety of anlotinib versus imatinib on advanced chordoma.
Interventions
DRUGAnlotinib Hydrochloride
anlotinib was given at a fixed dose of 12mg D1-14 every 21 days
Sponsors
Peking University Shougang Hospital
Peking University Third Hospital
Peking University First Hospital
Beijing Jishuitan Hospital
Chinese PLA General Hospital
Peking University Cancer Hospital & Institute
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years and older; * histologically proven metastatic or locally advanced chordoma, reviewed by the Pathology Committee of Peking University People's Hospital; * not amenable to curative-intent surgery; * measurable with computed tomography scan or magnetic resonance imaging, per RECIST, version 1.1.
Exclusion criteria
* Eastern Cooperative Oncology Group (ECOG)30 performance status more than 2 ; * life expectancy less than 12 weeks; * with severe or uncontrolled medical disorders (≥grade 2 of Common Terminology Criteria for Adverse Events version 4.03 \[CTCAE version 4.03\]) that could jeopardise the outcomes of the study, for example, cardiac clinical symptom or disease with LVEF (left ventricular ejection fraction) \<50%, hypertension that could not be well controlled through antihypertensive drugs and so on; * weight loss of 20% or more before illness; * brain or leptomeningeal metastasis; * surgical procedure or radiotherapy within 4 weeks of enrollment; * active gastroduodenal ulcer, previous condition associated with risk of bleeding or requiring anticoagulation; * proteinuria or hematuria; * denutrition with albuminemia less than 25 g/L; * pregnant or breastfeeding status; * other malignancy, positive HBV/HCV/HIV serology; * known allergy to the experimental agents; * had ever used anti-angiogenesis TKIs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate, ORR | 6 months | CR+PR in the intent-to-treat population according to RECIST, version 1.1 |
| Progression-free Survival, PFS | 2 years | Progression-free survival is defined as time from randomisation to the first occurrence of progression of disease or death from any cause within 63 days of last response assessment or randomisation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival, OS | 5 years | OS is defined as time from randomisation to the first occurrence of death from any cause within 63 days of last response assessment or randomisation. |
Countries
China
Contacts
Primary ContactLu Xie, M.D.
Backup ContactJie Xu, M.D.
Outcome results
None listed