Esophageal Squamous Cell Carcinoma
Conditions
Brief summary
In this prospective trial, patients demonstrating clinical complete response (cCR) as determined by a standard response assessment protocol (incorporating clinical and molecular diagnostic methods) will be offered organ-sparing management following neoadjuvant therapy with adebrelimab (anti-PD-L1) concurrent with chemoradiotherapy. The primary endpoint is 2-year overall survival rate in this watch-and-wait cohort.
Interventions
DRUGAdebrelimab and nab-paclitaxel and carboplatin
Adebrelimab combined with nab-paclitaxel and carboplatin as neoadjuvant therapy
RADIATIONRadiation
concurrent chemoradiotherapy
PROCEDUREstandard oesophagectomy
standard oesophagectomy
OTHERactive surveillance
active surveillance
Sponsors
Zhigang Li
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 medications. 2. immunosuppressants 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 |
|---|---|---|
| 2-year OS rate | 24 months | An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| median EFS | 24 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. |
| median OS | 24 months | An overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence. |
| cCR rate | 12 months | A clinical complete response rate (cCR) is defined as the complete disappearance of tumor lesions. |
| quality of life (QOL) | 24 months | Evaluate quality of life using EORTC QLQ-C30 |
| quality of life (QOL) assessed by EORTC QLQ-OES18 | 24 months | Evaluate quality of life using EORTC QLQ-OES18 |
| Incidence, type and severity of adverse events as assessed by CTCAE 5.0 | 24 months | Including adverse events and complications. Incidence of adverse events using CTCAE 5.0; grade 3 adverse events and higher-grade will be reported. |
Countries
China
Contacts
Primary ContactZhigang Li, MD, PhD
Backup ContactZhichao Liu, MD, PhD
Outcome results
None listed