A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

A Phase 1B Study of Donafenib Monotherapy in Advanced Oesophageal Cancer Progressing After Chemotherapy

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.

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.

Inclusion Criteria:

• All patients provided written, informed consent.
• Have histologically confirmed advanced oesophageal squamous-cell carcinoma, or type I/II Siewert junctional tumours.
• Have received up to two previous chemotherapy regimens( Platinum containing regimens & Paclitaxel / docetaxel containing regimens).
• Have an Eastern Cooperative Oncology Group Performance status of 0-1.
• Have ability to swallow tablets.
• no contraindications to sorafenib or donafenib.
• Have either measurable or evaluable lesion on CT.

Exclusion Criteria:

• Patients with brain metastases.
• Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.
• Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin >1.5 times upper limit of reference range, aspartate or alanine aminotransferase>2.5 times the upper limit of normal if no demonstrable liver disease) .