Phase
Condition
Lung Cancer
Esophageal Cancer
Squamous Cell Carcinoma
Treatment
Adebrelimab: 20mg/kg day1, Q3W, 3 times
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-75 years old, gender unlimited
Esophageal squamous cell carcinoma confirmed by histology and unresectable locallyadvanced or postoperative recurrence
According to the solid tumor efficacy evaluation criteria (RECIST1.1), there is atleast one measurable lesion; And the lesion had not received prior radiotherapy
ECOG: 0~1
Expected survival ≥12 weeks 6. Laboratory examination: neutrophils ≥1.5 x 109/L,platelets ≥100 x 109/L; Hemoglobin ≥ 9g/L; Albumin ≥ 2.8g/dL; Bilirubin ≤1.5 timesULN, ALT and AST≤2.5 times ULN
7: Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up 8: Tissue samples should be provided for biomarker analysis such as (PD-L1). Newly acquired tissues are preferred, and 15 5-6um thick paraffin sections can not be provided for archiving by the recent organizer
Exclusion
Exclusion Criteria:
Other malignant tumors have been diagnosed within the previous 5 years
There is distant organ metastasis (according to AJCC stage, supraclavicular lymphnode metastasis is M1, which should be excluded)
Lesions invading the trachea or large blood vessels, or investigators judge thatthere is a high risk of esophageal/tracheal fistula or bleeding
Have any history of active autoimmune disease or autoimmune disease
Have clinical symptoms or diseases of the heart that are not under control
Active infection or fever (except definite tumor fever)
History or evidence of interstitial lung disease or active non-infectious pneumonia
Patients with immune dysfunction and active hepatitis
Those who have previously received PD-1 or PD-L1 antibody therapy
Allergic to any drug in this protocol
Patients receiving immunosuppressive drugs or corticosteroids >10mg/ day ofprednisone therapeutic dose within 14 days prior to enrollment
Patients who had received radiotherapy, chemotherapy, targeted therapy, orimmunotherapy within 4 weeks prior to enrollment
Pregnant or lactating women
Study Design
Connect with a study center
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
ChinaActive - Recruiting

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