Clinical trial NCT04042597: Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma
Official title: A Prospective, Multicentre, Open-label, Randomised Phase 2 Trial to Study the Efficacy and Safety of Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Effect of Drugs
Quality of Life
Chordoma
Advanced Cancer
Keywords: chordoma
unresectable
anlotinib
imatinib
survival
quality of life
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Shougang Hospital
name: Peking University Third Hospital
name: Peking University First Hospital
name: Beijing Jishuitan Hospital
name: Chinese PLA General Hospital
name: Peking University Cancer Hospital & Institute
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2019-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate, ORR
timeFrame: 6 months
measure: Progression-free Survival, PFS
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival, OS
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Musculoskeletal Tumor Center of Peking University People's Hospital
name: Wei Guo, M.D. and Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: