Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:All patients will receive 3 cycles of camrelizumab (200mg, on days 1), concurrently with 3 cycles of Albumin paclitaxel/capecitabine (Albumin paclitaxel 260mg/m2, on days 1
capecitabine 1250mg/m2, on days 1-14). Esophagectomy is performed 6-8 weeks after neoadjuvant therapy completion
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years old of either gender; 2. Thoracic esophageal squamous cell carcinoma diagnosed by pathology; 3. No distant metastasis,the diseases could be resectable assessed by thoracic oncologist; 4. Clinical stage is T2-3N0-1M0,stage II-III according to AJCC8.0; 5. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1; 6. ECOG score 0-1; 7. Adequate heart,brain,lung,kidney and other organs function; 8. Estimated life expectancy >6 months; 9. Ability to understand the study and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have received or are receiving chemotherapy,radiotherapy,immunotherapy or targeted therapy; 2. Patients who bave other cancers; 3. Severe heart,liver,kidney diseases,including but not limited to the following:(> NYHA II congestive heart failure,ALT/AST>1.5ULN,Cr>1.5ULN); 4. Known or suspected allergy,usage of immunosuppressants before the enrollment, the amount of immunosuppressant used =10mg / day or oral prednisone for more than 2 weeks; 5. Severe allergies; 6. Abnormal blood coagulation function (PT>16s, APTT>53s, TT>21s, Fib<1.5g/L), bleeding tendency or receiving thrombolysis or anticoagulant therapy; 7. Female patients who are pregnant or lactating; 8. Other situations evaluated by investigators not meet the enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response (PCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response (CR);Partial Response (PR);Objective Response Rate (ORR);Major Pathological Response (MPR);1-year overall survival;1-year disease-free survival;Incidence of Treatment-related Adverse Events as Assessed by CTCAE v5.0; | — |
Countries
China
Contacts
Public ContactXu Zhang
Sun Yat-Sen University Cancer Center
Outcome results
None listed