Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma
NCT04844385 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2024-02-09
Summary
This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.
Conditions
Interventions
- DRUG
-
Toripalimab
Toripalimab 240 mg, d1, Q3w for two cycles
- DRUG
-
Paclitaxel-albumin
Paclitaxel-albumin 260 mg/m2, d1, Q3w for two cycles
- DRUG
-
Nedaplatin
Nedaplatin 75mg/m2, d1, Q3w for two cycles
- RADIATION
-
radiation therapy at a total dose 60 Gy
Radiation therapy at a total dose 60 Gy
- DRUG
-
Capecitabine 1000 mg/m2, bid, d1-14, q3w during radiotherapy
- RADIATION
-
radiation therapy at a total dose 50 Gy
Radiation therapy at a total dose 50 Gy
Sponsors & Collaborators
-
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Hui Liu, Professor · Sun yat-sen universtiy cancer center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-20
- Primary Completion
- 2024-12-20
- Completion
- 2024-12-20
Countries
- China
Study Locations
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