Trials / Unknown
UnknownNCT03817567
Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma
Phase Ib, Open-label, Single-arm, Multicenter Study to Evaluate Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma Progressed Following Treatment With Taxane/Platinum/Fluorouracil
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Sinocelltech Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil.
Detailed description
This is a open label, single-arm multicenter phase Ib study,and is designed to evaluate Objective Response Rate (ORR) in advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil treated with anti-EGFR monoclonal antibody SCT200.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | recombinant anti-EGFR monoclonal antibody | Experimental: Recombinant Anti-EGFR Monoclonal Antibody（SCT200）. Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression. |
Timeline
- Start date
- 2018-07-17
- Primary completion
- 2019-11-30
- Completion
- 2020-05-31
- First posted
- 2019-01-25
- Last updated
- 2019-01-25
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03817567. Inclusion in this directory is not an endorsement.