Esophageal carcinoma
Conditions
Interventions
Experimental group:Surgical treatment of esophageal cancer after local recurrence
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Age of subjects: 18-80 years old 2) Esophageal squamous cell carcinoma after radical resection (the specific surgical method is not limited) 3) Local recurrence and metastasis after surgery and evaluation of the lesion (potential) resectable before treatment 4) During the screening period, all subjects must undergo a comprehensive physical examination and imaging evaluation to ensure that there is no distant metastasis. Imaging evaluation must include upper gastrointestinal angiography, CT/MRI of the neck, chest, and upper abdomen, and color Doppler ultrasound or PET-CT of the cervical lymph nodes. 5)ECOG score :0-1; 6) ASA: Level I-III 7) Major organ function is normal, that is, meet the following criteria: (1) Blood routine examination: a.HB=90g/L; b.ANC=1.5×10^9/L; C. PLT =80×10^9/L; (2) Biochemical examination: A.LB =30g/L; B.ALT and AST=2.5ULN; C.TBIL =1.5ULN; d. Plasma Cr=1.5ULN or creatinine clearance (CCr)=60ml/min; 8) Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) = the lower limit of normal value (50%); 9) Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Men should consent to patients who must use contraception during the study period and for 6 months after the end of the study period; 10) The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1) A second primary cancer unrelated to the primary tumor of the esophagus is present or evaluated as unresectable. 2) Patients with distant metastases 3) Past medical history and complicated diseases a. Prior history of other malignancies, unless complete remission has been achieved at least 5 years prior to study entry, and no additional treatment is required or expected to be required during the study period (exceptions include, but are not limited to, non-melanoma skin cancer; Carcinoma in situ of the bladder or colon; Cervical carcinoma in situ; Carcinoma in situ) b. Subjects with a known or suspected active autoimmune disease are allowed to be enrolled with type I diabetes, hypothyroidism requiring hormone replacement therapy only, skin conditions that do not require systemic treatment (e.g., vitiligo, psoriasis, or hair loss), or conditions that are not expected to recur in the absence of external triggers c. Patients requiring systemic treatment with corticosteroids (> 10mg daily prednisone or equivalent) or other immunosuppressive drugs within 14 days prior to administration of the study drug; In the absence of active autoimmune disease, inhaled or topical steroids and adrenal substitute steroids at an equivalent dose of > 10mg per day of prednisone are permitted d. Those who have symptoms or are likely to cause drug-related pulmonary toxicity or treatment-related interstitial lung disease e. People who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibody or drug therapy that specifically targets T cell co-stimulation or checkpoint pathways f. All toxic side effects (other than nephropathy, neuropathy, hearing loss, hair loss, and fatigue) attributable to prior antitumor therapy (preoperative induction therapy) must be restored to baseline or Grade 1 before administration of the study drug (CTCAE version 5.0); Participants who develop toxicity that can be attributed to prior anti-cancer therapy, is not expected to be alleviated, and leads to lasting sequelae (e.g., peripheral neuropathy that occurs after platinum-containing therapy) are admitted to the study; Peripheral neuropathy must be remitted to Grade 2 (CTCAE version 5.0) g. Any serious or uncontrolled medical illness or active infection that, in the investigator's judgment, may increase study participation, the risks associated with study drug administration, or may impair the subject's ability to receive treatment under the trial protocol h. Known human immunodeficiency virus (HIV) testing history or known to have acquired immunodeficiency syndrome (AIDS) (Note: HIV testing must be performed at a research center mandated by local regulations) i. Any positive test result for hepatitis B virus or hepatitis C virus that indicates the presence of the virus, such as hepatitis B surface antigen (HBsAg) positive or hepatitis C antibody (anti-HCV) positive (except HCV-RNA negative) j. Subjects who received the live/attenuated vaccine within 30 days of receiving the first treatment 4) Drug allergy and adverse reactions A. a history of allergy or hypersensitivity to the ingredients of the study drug b. People with severe hypersensitivity to any monoclonal antibody 5) Other exclusion criteria a. Prisoners or persons held in involuntary confinement b. Persons detained against their will for the treatment of mental or physical diseases (e.g., class A, class B infectious diseases)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;DFS;The incidence, causal relationship, and outcome of adverse events/serious adverse events;Changes in vital signs and laboratory test results;Patient-Reported Outcomes, PROs; | — |
Countries
China
Contacts
Public ContactLi Xiangnan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed