Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04042597
Other study ID # PKUPH-sarcoma 05
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT06238557 - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT05472935 - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers N/A
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04281953 - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Active, not recruiting NCT04746664 - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia N/A
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Recruiting NCT04142827 - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) N/A
Active, not recruiting NCT05903638 - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility N/A
Completed NCT05538455 - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases N/A
Completed NCT06216015 - Exercise Training and Kidney Transplantation N/A
Completed NCT03813420 - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level N/A
Recruiting NCT05550545 - Infant RSV Infections and Health-related Quality of Life of Families
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05233020 - Robotic Versus Hybrid Assisted Ventral Hernia Repair N/A
Terminated NCT03304184 - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life Phase 3
Completed NCT05063305 - Probiotics, Immunity, Stress, and QofL N/A
Recruiting NCT05380856 - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction N/A