CSSG-03: Anlotinib Hydrochloride Versus Imatinib Mesylate in Locally Advanced, Unresectable or Metastatic Chordoma

Sponsor

Peking University People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04042597

Collaborator

Peking University Shougang Hospital (Other), Peking University Third Hospital (Other), Peking University First Hospital (Other), Beijing Jishuitan Hospital (Other), Chinese PLA General Hospital (Other), Peking University Cancer Hospital & Institute (Other), Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Other)

Enrollment

Location

Arms

29.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Effect of Drugs Quality of Life Chordoma Advanced Cancer	Drug: Anlotinib Hydrochloride	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 18, 2019

Anticipated Primary Completion Date :

Oct 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: anlotinib arm anlotinib was given at a fixed dose of 12mg D1-14 every 21 days	Drug: Anlotinib Hydrochloride anlotinib was given at a fixed dose of 12mg D1-14 every 21 days
Active Comparator: Arm B: imatinib arm Imatinib was given at dose of 400 mg twice daily continuously	Drug: Anlotinib Hydrochloride anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Arm

Intervention/Treatment

Experimental: Arm A: anlotinib arm

anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Drug: Anlotinib Hydrochloride

anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Active Comparator: Arm B: imatinib arm

Imatinib was given at dose of 400 mg twice daily continuously

Drug: Anlotinib Hydrochloride

anlotinib was given at a fixed dose of 12mg D1-14 every 21 days

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.