drugset / Trial / NCT06136988
A Study of Docetaxel for Injection (Albumin-bound) and SG001 in Combination With Cisplatin and Simultaneous Radiotherapy for Locally Advanced Unresectable Esophageal Squamous Carcinoma.
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is a multicenter, open-label, phase Ib/II study to evaluate the efficacy and safety of docetaxel for injection (albumin-bound) (HB1801) and SG001 in combination with cisplatin and simultaneous radiotherapy versus paclitaxel in combination with cisplatin and simultaneous radiotherapy for locally advanced unresectable esophageal squamous carcinoma.
Timeline
- Start
- 2023-12
- Primary completion
- 2027-04
- Completion
- 2028-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel for Injection (Albumin-bound) | Unknown | 60 mg/m2 | Intravenous |
| Subject | Docetaxel for Injection (Albumin-bound) | Unknown | 75 mg/m2 | Intravenous |
| Subject | Enlonstobart | Monoclonal antibody | 360 mg | Intravenous |
| Comparator | Paclitaxel | Small molecule | 135 mg/m2 | Intravenous |
| Background | Cisplatin for injection | Unknown | 25 mg/m2 | Intravenous |