Spots Global Cancer Trial Database for A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer
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Trial Identification
Brief Title: A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer
Official Title: A Phase 1B Study of Donafenib Monotherapy in Advanced Oesophageal Cancer Progressing After Chemotherapy
Study ID: NCT02489201
Conditions
Interventions
Study Description
Brief Summary: This open-label, one-center, noncomparative, two-stages phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced, inoperable oesophageal cancer progressing after chemotherapy . The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival.
Detailed Description: This open-label, noncomparative, two-part phase 1B trial recruited patients with advanced, inoperable oesophageal cancer. The primary objectives were to assess the safety for donafenib tosylate tablets .The secondary objectives were to estimate tumor response, progression-free survival, duration of response, and disease control rate (response plus stable disease); to evaluate changes in quality of life(QoL); This study is 2-stages designing. The investigators plan to enroll 19 patients in the first stage study. The investigators will start the secondary stage study if the disease control rate \>=8/19.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Affiliated Cancer Center of Academy of Military Medical Sciences, Beijing, , China
Contact Details
Name: Jianming Xu, Doctor
Affiliation: The Affiliated Hospital of Military Medical Science
Role: PRINCIPAL_INVESTIGATOR
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