Status:
UNKNOWN
A Study of Anti-PD-L1 Antibody in Neoadjuvant Chemotherapy of Esophageal Squamous Cell Carcinoma.
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a randomized, double-blind, placebo-controlled Ib/Ⅱ clinical study to evaluate the safety and effect of anti-PD-L1 antibody (ZKAB001) in neoadjuvant chemotherapy of esophageal squamous carcino...
Eligibility Criteria
Inclusion
- Key inclusion Criteria:
- Aged 18 to 75 years old of either gender;
- A histopathological diagnosis of esophageal squamous cell carcinoma with a clinical stage of T2N+M0 or T3-4aN+/-M0 according to the 8th edition of the UICC staging system;
- ECOG score 0-1;
- Estimated life expectancy \>3 months;
- BMI ≥18.5kg/m2 or PG-SGA score A/B;
- The function of important organs meets the following requirements:
- white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
- ALT, AST and AKP ≤ 2.5×ULN;
- serum albumin ≥ 30g/L;
- total bilirubin ≤ 1.5×ULN;
- serum creatinine ≤ 1.0×ULN, creatinine clearance rate ≥60 mL/min;
- INR ≤ 1.5, PT≤ 1.5×ULN;
- Cardiac function: ≤I, pulmonary function: FEV1 \>1.2L, FEV1% \>40%, liver function: Child-Pugh 5-6;
- Serum HCG negative in premenopausal women ;
- Ability to understand the study and sign informed consent.
- Key exclusion Criteria:
- Cervical esophageal carcinoma;
- Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
- Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of anti-PD-L1 antibody and chemotherapeutic drugs;
- Active autoimmune diseases;
- A history of allogeneic stem cell transplantation and organ transplantation;
- A history of interstitial lung disease or non-infectious pneumonia;
- Patients who cannot tolerate chemotherapy or surgery due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia;
- A history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases;
- Presence of active hepatitis B (HBV DNA ≥ 200 IU/mL or 103 copies/mL), hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);
- A history of active pulmonary tuberculosis infection within 1 year or a history of active pulmonary tuberculosis infection more than 1 year ago but without formal anti-tuberculosis treatment;
- A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
- Lymph node metastasis in neck, supraclavicular, abdominal cavity, retroperitoneum and pelvic cavity (except paracardial and left gastric lymph nodes).
Exclusion
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2023
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04460066
Start Date
November 18 2020
End Date
July 15 2023
Last Update
May 4 2022
Active Locations (1)
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1
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100000