Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Esophageal Squamous Cell Carcinoma, Locally advanced, Chemoimmunotherapy, Radioimmunotherapy
Brief summary
The goal of this study was to explore the efficacy and safety of neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy in patients with locally advanced esophageal squamous cell carcinoma
Interventions
PROCEDURENeoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Neoadjuvant chemoimmunotherapy followed by surgery and postoperative radioimmunotherapy
Sponsors
Anhui Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18-75; * Radical operation for esophageal cancer; * Esophageal squamous cell carcinoma was confirmed by postoperative pathology; . Preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation were performed, and the stage was pIIB-IVA (AJCC eighth edition staging criteria: T≥3 or N+). * More than or equal to 12 lymph nodes were surgically removed; * Postoperative ECOG score 0-1, able to tolerate postoperative adjuvant radiotherapy and immunotherapy; * Informed consent signed by patient or family member.
Exclusion criteria
* Less than 18 years old, more than 75 years old; * did not receive radical resection of esophageal cancer, including palliative resection; * Postoperative pathology showed non-esophageal squamous cell carcinoma; * After preoperative imaging (enhanced cervical, thoracoabdominal CT+ bone scan) and postoperative pathological evaluation, the stage was pI, IIA, IVB (AJCC eighth edition staging standard); e. Less than 12 lymph nodes were surgically removed; * Postoperative ECOG score 2-3 points, unable to tolerate postoperative adjuvant radiotherapy and immunotherapy; * The patient or family member did not sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | immediately after the intervention/procedure/surgery | Pathologic Complete Response |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate | immediately after the intervention/procedure/surgery | R0 resection rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| 1#3-year disease free survival | immediately after the intervention/procedure/surgery | 1#3-year disease free survival |
Countries
China
Outcome results
None listed