Clinical trial · Interventional
A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer
A Phase 1B Study of Donafenib Monotherapy in Advanced Oesophageal Cancer Progressing After Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Corporate policy adjustments
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oesophageal Cancer | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| donafenib tosilate tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- donafenib tosilate tablets
- description
- 200mg bid
- interventionNames
- Drug: donafenib tosilate tablets
Primary outcomes (1)
- measure
- Number of participants with Adverse Events
- timeFrame
- 54 weeks
- description
- percentage of any adverse events
Secondary outcomes (2)
- measure
- Tumor response
- timeFrame
- 54 weeks
- description
- Tumor evaluation by investigators according to RECIST 1.1 criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) .
References
Publications (0)
Data not yet available