Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03279744 | A Study to Evaluate the Efficacy and Safety of Radion™-Pdt in Patients With Oral Precancerous Lesion | PHASE2 | COMPLETED | 25 | — | — | Sep 6, 2017 | Dec 20, 2019 | Jan 2, 2020 | 1 | Taiwan |
The complete response rate at the end of treatment will be calculated by the proportion of complete response patients in total. The primary efficacy endpoints will be summarized by examining whether the complete response rate is higher or equal to 70% of total. Complete response (CR): lack of detectable lesion confirmed by visual evaluation.
| Arm | Type | Description |
|---|---|---|
| Single-Arm | EXPERIMENTAL | Radion™-pdt |
| Name | Type | Description |
|---|---|---|
| Radion™-pdt | DRUG | The Radion™-pdt will be applied topically to the lesion. The Radion™-pdt applied dosage is about 0.1 mL/cm\^2 and properly cover the entire lesion. |
Inclusion Criteria: 1. Patients aged ≥20 years old; 2. Patient with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL) lesions with histological evidence of oral precancerous lesions. Besides, patients should have at least one lesion whose size should not exceed 4 cm in the greatest ...