A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02489201
Study type	Interventional
Source	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	July 21, 2015
Completion date	October 29, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05685862` - Laser Speckle Contrast Imaging, Surgical Eye & ICG Fluorescence Imaging for Perfusion Assessment of the Gastric Conduit
Recruiting	`NCT01795768` - Proof-of-Concept Study of AZD4547 in Patients With FGFR1 or FGFR2 Amplified Tumours	Phase 2
Completed	`NCT05266300` - Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines.
Recruiting	`NCT03978377` - Cardiopulmonary Toxicity of Thoracic Radiotherapy
Active, not recruiting	`NCT03653052` - Do Changes in ctDNA Predict Response for Patients With Oesophageal Cancer Receiving Durvalumab	Phase 2
Recruiting	`NCT05489250` - The PLATON Network
Recruiting	`NCT04484636` - PLATON - Platform for Analyzing Targetable Tumor Mutations (Pilot-study)	N/A
Terminated	`NCT01795976` - NY-ESO-1 T Cells in OG Cancer	Phase 2
Recruiting	`NCT01843829` - A Feasibility Study of Chemo-radiotherapy to Treat Operable Oesophageal Cancer	Phase 2
Completed	`NCT01915693` - ROCS (Radiotherapy After Oesophageal Cancer Stenting) Study	Phase 3
Completed	`NCT02382237` - Comparison of Tumor Glucose Metabolism Before and After Artificial Nutrition	N/A
Recruiting	`NCT04517448` - Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy
Recruiting	`NCT04232735` - Evidence Based Information Provision to Improve Decision Making After Oesophagogastric Cancer Diagnosis (SOURCE)	N/A
Recruiting	`NCT05642819` - REVOLUTION Surgery (REVOLUTION Surgery)
Recruiting	`NCT04001478` - Non-invasive Testing for Early oEesophageal Cancer and Dysplasia
Recruiting	`NCT02741856` - Study of Chemoradiotherapy in Oesophageal Cancer Including PET Response and Dose Escalation	Phase 2/Phase 3
Not yet recruiting	`NCT05600608` - Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome	N/A
Recruiting	`NCT04481256` - TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY	N/A
Recruiting	`NCT05057013` - HMBD-001 in Advanced HER3 Positive Solid Tumours	Phase 1/Phase 2
Not yet recruiting	`NCT06046846` - Prehabilitation Via a Mobile Application in Oesophago-gastric Cancer	N/A