The objective of this study is to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy followed by sequential endoscopic resection in patients with cT1bN0M0 esophageal cancer Cancer
Conditions
Interventions
Patients with cT1bN0M0 esophageal cancer who meet the inclusion and exclusion criteria will receive 3 cycles of concurrent neoadjuvant chemotherapy (an albumin-bound intravenous infusion of paclitaxel
Sponsors
Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years, =75 years 2. Diagnosis of esophageal squamous cell carcinoma confirmed by biopsy according to at least one of the following criteria: 2.1. Lesion infiltration into the submucosa, as determined by combined gastroscopy and endoscopic ultrasound 2.2. No obvious lymph node metastasis or distant metastasis
Exclusion criteria
Exclusion criteria: 1. Esophageal adenocarcinoma and precancerous lesions 2. Current antiplatelet, anticoagulant, or thrombolytic therapy (such as with warfarin, heparin, clopidogrel, aspirin, streptokinase, and urokinase) 3. Myocardial infarction or other severe heart diseases in the past 6 months 4. Serious cerebrovascular diseases, such as cerebral hemorrhage and cerebral infarction, in the past 6 months 5. Previous surgery or chemotherapy and immunotherapy other than radiofrequency therapy, cryotherapy, photodynamic therapy, or ER due to esophageal tumors 6. Unmanaged mental illness and/or known drug or alcohol dependence that has not been cured, which limits the ability to understand or follow the instructions related to informed consent, post-treatment instructions or follow-up guidelines 7. Incomplete clinical data (ambiguous diagnosis, incomplete medical history, incomplete medication records, etc.) 8. Regional lymph node metastasis confirmed by imaging examination and needle biopsy 9. Signs of eosinophilic esophagitis found on endoscopic examination and/or histological examination 10. Grade C or D active reflux esophagitis 11. Allergy to platinum or paclitaxel 12. Pregnancy/lactation 13. Inability to provide signed informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) measured using histopathological specimens after endoscopic resection | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease-free survival (DFS), defined as the time from resection to recurrence of tumor or death, measured using data collected in medical records at one time point 2. Overall survival (OS), defined as the time from study inclusion to death, measured using data collected in medical records at one time point | — |
Countries
China
Contacts
Public ContactLizhou Dou
Outcome results
None listed