Last reviewed · How we verify
A Phase II Study to Assess the Safety and Efficacy of PTS100 in Primary Hepatocellular Carcinoma Patients Who Are Ineligible for Operation or Current Locoregional Therapy (OASES)
This study is being performed to evaluate the efficacy and safety of 30% PTS100 of total tumor volume as intra-tumoral injection therapy in primary Hepatocellular Carcinoma patients who are ineligible for operation or local regional therapy.
Details
| Lead sponsor | Gongwin Biopharm Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 33 |
| Start date | 2018-06-19 |
| Completion | 2025-12 |
Conditions
- Hepatocellular Carcinoma
Interventions
- Para-Toluenesulfonamide
Primary outcomes
- Objective Response Rate (ORR) — 4-week post treatment
To evaluate the efficacy, measured by objective response rate (ORR) of pooled treatment groups based on the modified RECIST (mRECIST) criteria at concluding visit.
Countries
Taiwan