Phase
Condition
Lung Cancer
Squamous Cell Carcinoma
Esophageal Cancer
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signing informed consent; ECOG 0-2 points;
Age over 18 years old, gender is not limited;
Esophageal squamous cell carcinoma confirmed by pathology or clinically diagnosed byimaging;
Recurrence of the tumor area after radical surgery or radical chemoradiotherapy;Regional progression of advanced esophageal squamous cell carcinoma after first-lineor second-line treatment;
Clinical staging: regional recurrence (rT0-4N0-3M0-1a) or regional progression (cT0-4N0-3M0-1) (AJCC/UICC esophageal cancer staging (8th edition));
Tumor lesions can be evaluated;
Expected survival ≥3 months;
Major organ function is normal, meeting the following criteria: (i) blood routineexamination A.HB ≥90g/L; b.ANC≥1.5×109/L; C. PLT ≥80×109/L; (ii) Biochemicalexamination: a. ALT/AST≤2.5ULN; b. TBIL≤1.5ULN; c. Plasma Cr≤1.5ULN or creatinineclearance (CCr)≥60ml/min;
Women of childbearing age must have had a pregnancy within 7 days before startingtreatment and the result is negative;
All enrolled patients should take adequate contraceptive measures throughout thetreatment period and 4 weeks after completion;
no serious hematopoietic function, heart function, endocrine and immune functiondefects;
No patients with grade 3 or above other serious medical diseases.
Exclusion
Exclusion Criteria:
Under 18 years of age; ECOG is greater than 2;
The diagnosis of esophageal cancer is not supported by pathological biopsy or imageexamination;
Salvage surgery was performed after tumor recurrence;
The patient has any active autoimmune disease (such as the following, but notlimited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis,hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient hadvitiligo; Those with complete remission of asthma in childhood can be includedwithout any intervention in adulthood; Patients with asthma requiring medicalintervention with bronchodilators are not included);
Patients who were taking immunosuppressants or systemic hormone therapy forimmunosuppressive purposes (doses >10mg/ day of prednisone or other therapeutichormones) and continued to use within 2 weeks before enrollment;
Patients with severe and/or uncontrolled concomitant disease of grade 3 or higher,including: poor blood pressure control, myocardial ischemia or myocardialinfarction, arrhythmia, active or uncontrolled severe infection; Liver diseases suchas decompensated liver disease, active hepatitis B (HBV-DNA≥104 copy numbers /ml or 2000IU/ml), or hepatitis C (hepatitis C antibody positive and HCV-RNA above thelower detection limit of analytical methods);
Pregnant or lactating women;
Patients who have a history of psychotropic drug abuse and cannot quit or havemental disorders;
Patients who have participated in clinical trials of other drugs within four weeks; .Patients or family members refused to participate in the study.
Study Design
Connect with a study center
Yuan He
Hefei, 230001
ChinaActive - Recruiting

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