Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
This study aims to evaluate the efficacy of Camrelizumab with neoadjuvant chemotherapy for resectable thoracic esophageal squamous cell carcinoma
Interventions
DRUGCamrelizumab
Camrelizumab 200mg D1, D22
Paclitaxel for Injection (Albumin Bound) 100mg/m\^2 D1, D8, D22, D29
DRUGCarboplatin
Carboplatin AUC5 D1, D22
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histological diagnosis of thoracic Esophageal squamous cell carcinoma * ECOG performance status 0-1 * Age 18-75 years * Resectable disease, cT2-4aNanyM0 or cT1-3N+M0 * Life expectancy more than 6 months * Use of an effective contraceptive for adults to prevent pregnancy
Exclusion criteria
* Not suitable for surgery * Prior chemotherapy, radiotherapy and immune-oncology therapies for ESCC * Prior esophageal, gastric, or gastro-esophageal junction surgery * Esophageal ulcer, esophageal perforation，chest pain（≥middle level） * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete remission (PCR) | 12 weeks |
| Major Pathologic Response (MPR) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) | 5 years |
| Event Free Survival（EFS） | 5 years |
Other
| Measure | Time frame | Description |
|---|---|---|
| EQ-5D-3L questionnaire | 5 years | — |
| FACT-E questionnaire | 5 years | Functional Assessment of Cancer Therapy for patients with esophageal cancer questionnaire - version 4 (FACT-E) |
Countries
China
Outcome results
None listed