esophageal squamous cell carcinoma
Conditions
Interventions
treatment group:Neoadjuvant chemotherapy with immunotherapy
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1: Age: >=18 years old, = 1 3: The main depth of tumor invasion confirmed by gastroscopy and endoscopic ultrasound is cT1b 4: Confirm the cN0/M0 stage through B-ultrasound of CT 5: In patients with multiple Lugol stain-negative lesions, the absence of synchronous cancer was confirmed by an otolaryngologist or head and neck surgeon 6: There were no ulcerative lesions in the tumor 7: No previous chemotherapy or radiotherapy for any other malignancy, and no previous treatment for esophageal cancer other than ER (diagnosed as pEP, pLPM, or pMM tumor without lymphovascular invasion) 8: ECOG score of 0 or 1, able to tolerate gastroscopy and biopsy 9: The subjects voluntarily signed the written informed consent form (ICF) to participate in this clinical study and understood their obligations to participate in the study.
Exclusion criteria
Exclusion criteria: 1: Esophageal adenocarcinoma and its precancerous lesions 2: Patients who are receiving antiplatelet, anticoagulation, or thrombolytic therapy (such as currently or recently using warfarin, heparin, clopidogrel, aspirin, streptokinase, urokinase, etc.) 3: Patients who have had myocardial infarction or other serious heart disease in the past 6 months 4: Severe cerebrovascular diseases such as cerebral hemorrhage and cerebral infarction have occurred in the past 6 months 5: The patient has previously received surgery or chemotherapy and immunotherapy for esophageal tumors other than radiofrequency, cryotherapy, photodynamic, and endoscopic resection 6: Have an uncontrolled mental illness, and/or a known unresolved drug or alcohol dependence that limits the ability to understand or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines 7: Those with incomplete clinical data (unclear diagnosis, incomplete medical history, incomplete medication records, etc.) 8: Those who have confirmed regional lymph node metastasis by imaging and biopsy 9: Signs of eosinophilic esophagitis on endoscopy and/or histology 10: The patient's active reflux esophagitis is graded C or D 11: Those allergic to iodine, platinum or paclitaxel 12: Pregnancy/lactation 13: Unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event Free Survival, EFS;overall survival, OS; | — |
Countries
China
Contacts
Public ContactWang Guiqi
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College
Outcome results
None listed