esophageal squamous carcinoma
Conditions
Interventions
Test group:Adebrelimab + albumin-bound paclitaxel + cisplatin
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years old, gender not limited; 2. Patients with esophageal squamous cell carcinoma confirmed by histopathology or cytology 2.1 Patients diagnosed with esophageal squamous cell carcinoma by gastroscopy biopsy and with tissue specimens collected before enrollment. 2.2 The primary tumor is located in the chest. The primary site of esophageal cancer is determined by the position of the upper edge of the mass in the esophagus (upper thoracic esophagus: from the entrance of the thorax to the lower edge of the arch of the oddball, endoscopic examination is 25cm away from the incisors; middle thoracic esophagus: from the lower edge of the arch of the oddball to the lower pulmonary vein, endoscopic examination is 25cm to 30cm away from the incisors; lower thoracic esophagus: above the lower pulmonary vein and downward to the stomach. Endoscopy: 30 to 40 centimeters away from the front teeth. 3. Tumor Staging 3.1 The pre-treatment stage was cT1-2N1-3M0 or cT3-4a, any NM0 (AJCC/UICC 8th Edition) (if it was cT4a stage, curative and resectable conditions must be clearly verified by experienced surgical researchers); 3.2 After being diagnosed with esophageal squamous cell carcinoma by gastroscopy biopsy, based on the above criteria, before enrollment, patients can be evaluated by means such as PET-CT, enhanced CT of the chest and abdomen, and cervical lymph node ultrasound to determine whether there is obvious tumor invasion, whether there is obvious enlargement of mediastinal lymph nodes, and whether there is distant organ metastasis. If the primary tumor is suspected to be T4, multiple mediastinal lymph node metastases or distant metastases, whole-body PET-CT and endoscopic ultrasound (EUS) (optional) will be performed to further determine the clinical stage. 4. Measurable lesions as defined in RECIST standard v1.1; 5. It has adequate organ and bone marrow functions, defined as follows: hemoglobin >=9.0g/dL, absolute neutrophil count >=1.5×10^9/L, platelet count >=100×10^9/L, INR=1.5, total bilirubin (TBL) = 3.0 g/dL, serum creatinine 60 mL/min or calculated creatinine clearance > 60 mL/min based on the Cockcroft-Gault formula (using actual body weight): for males, creatinine clearance = (weight × (140 - age)) / (72 × serum creatinine); for females, creatinine clearance = (weight × (140 - age)) / (72 × serum creatinine) × 0.85, where CL = mL/min; serum creatinine = mg/dL; 6. Patients with active HBV infection should have received antiviral treatment for more than 2 weeks in accordance with local antiviral treatment guidelines before enrollment and should continue treatment for 6 months after study drug administration; 7. HCV antibody test is negative at screening, or HCV antibody test is positive at screening but subsequent HCV RNA test is negative; 8. The investigator determines that the patient can receive adibelimab treatment; 9. Voluntary participation in this study and signing the informed consent form.
Exclusion criteria
Exclusion criteria: Patients with histological diagnosis of non-squamous cell carcinoma; 2. Patients with advanced esophageal cancer who are inoperable or have metastatic esophageal cancer; 3. Active or previously recorded autoimmune diseases or inflammatory diseases (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis (except diverticular disease), systemic lupus erythematosus, sarcoidosis syndrome or Wegener syndrome [granuloma with polyangiitis, Graves' disease, rheumatoid arthritis, pituitary inflammation and uveitis, etc.]). The following are the exceptions to this standard: (a) Patients with vitiligo or alopecia; (b) Patients with hypothyroidism (e.g., after Hashimoto syndrome) who are receiving stable hormone replacement therapy; (c) Any chronic skin disease that does not require systemic treatment; (d) Patients without active diseases in the past five years can be included, but only after consulting the study physician. (e) Patients with celiac disease who can control their condition solely through diet; 4. Active infections, including tuberculosis (clinical evaluation includes clinical history, physical examination, imaging results and tuberculosis tests in line with local treatment principles); 5. Uncontrolled complications, including but not limited to persistent or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, and severe chronic gastrointestinal diseases accompanied by diarrhea Mental illness/social conditions that limit research requirements for compliance, significantly increase the risk of adverse events, or impair patients' ability to provide written informed consent; 6 There was a history of thyroid dysfunction, and despite drug treatment, the thyroid function still could not be maintained within the normal range. 7. Within 14 days prior to the first administration of adebe???ab, the patient is currently using or has previously used immunosuppressive drugs. The following are exceptions to this criterion: (a) intranasal, inhaled, topical steroids or local steroid injections (e.g., intra-articular injections); (b) systemic glucocorticoids not exceeding physiological doses, equivalent to 10mg/day of prednisone or its equivalent; (c) steroids as premedication for hypersensitivity reactions (e.g., premedication for CT scans). 8. Has a history of substance abuse of psychotropic drugs and is unable to quit or has a mental disorder. 9. Known history or evidence of interstitial lung disease or active non-infectious pneumonia. 10. Received a live attenuated vaccine within 30 days prior to the first administration of the study drug. Note: If enrolled, the patient is not allowed to receive a live vaccine during the treatment period with the study drug and within 30 days after the last administration of the study drug. 11. Known to have an allergic reaction or hypersensitivity to any study drug or its any excipients. 12. Concurrently enrolled in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an intervention study. 13. Other situations deemed unsuitable for inclusion in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response, pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Pathological response,MPR;R0 resection rate;Disease-Free Survival, DFS;Overall survival, OS;Objective Response Rate, ORR;Disease control rate,DCR;Safety;Satisfaction with the surgical treatment process of surgeons; | — |
Countries
China
Contacts
Public ContactJing Xu
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed