Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma

Quality of Life Clinical Trial

— CSSG-03  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04042597
• Other study ID #: PKUPH-sarcoma 05
• Status: Recruiting
• Phase: Phase 2
• Start date: July 18, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2019
• Source: Peking University People's Hospital
• Contact: Lu Xie, M.D.
• Phone: +8613401044719
• Email: xie.lu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Chordoma
• Effect of Drugs
• Quality of Life

Intervention

Drug:
• Anlotinib Hydrochloride
anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing Cancer Hospital, Beijing Jishuitan Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Chinese PLA General Hospital, Peking University First Hospital, Peking University Shougang Hospital, Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate, ORR	CR+PR in the intent-to-treat population according to RECIST, version 1.1	6 months
Primary	Progression-free Survival, PFS	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	2 years
Secondary	Overall Survival, OS	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.	5 years