Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
The investigators will conduct a single-arm prospective study to evaluate the efficacy and safety of neoadjuvant therapy with adebrelimab (SHR-1316) and chemotherapy in patients with resectable esophageal squamous cell carcinoma (ESCC).
Interventions
DRUGImmunotherapy: Adebrelimab
Adebrelimab 1200mg Q3W
DRUGchemotherapy: carboplatin plus nab-paclitaxel
carboplatin plus nab-paclitaxel
Sponsors
Shanghai Chest 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
1. Subjects signed the informed consent and volunteered to participate in the study. 2. Esophageal squamous cell carcinoma confirmed by histology or cytology. 3. Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as cII-III (AJCC 8th). 4. Expect to have R0 resection 5. In age from 18 to 75. 6. ECOG PS: 0\ 1. 7. Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc. 8. No contraindications to surgery. 9. Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min（Cocheroft-Gault) (3) Coagulation function: INR≤1.5; APTT≤1.5×ULN 10. Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to three months after last administration. 11. Good compliance, willing to comply with follow-up schedules.
Exclusion criteria
1. Subjects have received or are receiving any of: 1. anti-tumor interventions such as radiotherapy, chemotherapy or other medictions. 2. immunosuppresants or systemic glucosteroids (prednisone equivalence\> 10mg/d) within 2 weeks before the first administration, inhaled or topical use of glucosteroids (prednisone equivalence\>10mg/d) is allowed if no known active autoimmune disease. 3. live vaccine within 4 weeks before the first administration. 4. major surgery or major injury within 4 weeks before the first administration. 2. Cancer related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR rate | 12 months | The primary endpoint is a pCR rate, which is defined as the absence of any remaining tumor cells in both the main tumor and the nearby lymph nodes (ypT0N0) as per the AJCC 8th Edition TRG scoring system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | 12 months | A R0 resection rate is defined as the rate of complete tumor removal with negative resection margin microscopically |
| MPR rate | 12 months | A major pathological response rate (MPR) is defined as the proportion of residual living tumor cells in the post-surgery specimen within the tumor bed being less than or equal to 10%. |
| median EFS | 12 months | An event-free survival (EFS) is defined as the duration from the start of treatment until disease recurrence or death from any cause, whichever occurs first. |
| cCR rate | 12 months | A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions as assessed by enhanced CT, endoscopic ultrasound, and endoscopic biopsy. |
| Incidence, type and severity of adverse events as assessed by CTCAE 5.0 | From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose | Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 treatment-related adverse events and higher-grade will be reported |
| Potential biomarkers such as ctDNA or PD-L1 expression | 12 months | Potential biomarkers such as ctDNA or PD-L1 expression will be explored and analysed using blood or tissues prior and post-treatment. |
| median OS | 12 months | An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence. |
Countries
China
Contacts
Primary ContactZhigang Li, MD, PhD
Backup ContactYang Yang
Outcome results
None listed