A Study of Anti-PD-L1 Antibody in Perioperative Chemotherapy of Esophageal Carcinoma.

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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 perioperative chemotherapy of esophageal squamous carcinoma in combination with Alb-paclitaxel and cisplatin. The immunotherapy will be given before and after the operation every three weeks.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lee's Pharmaceutical Limited
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Paclitaxel

Criteria

Key inclusion Criteria:

1. Aged 18 to 70 years old of either gender;

2. 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;

3. ECOG score 0-1;

4. Estimated life expectancy >3 months;

5. BMI ≥18.5kg/m2 or PG-SGA score A/B;

6. The function of important organs meets the following requirements:

1. white blood cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;

2. ALT, AST and AKP ≤ 2.5×ULN;

3. serum albumin ≥ 30g/L;

4. total bilirubin ≤ 1.5×ULN;

5. serum creatinine ≤ 1.0×ULN, creatinine clearance rate ≥80 mL/min;

6. INR ≤ 1.5, PT≤ 1.5×ULN;

7. Cardiac function: I, pulmonary function: VC%>60%, FEV1 >1.2L, FEV1% >40%, DLCO >40%, liver function: Child-Pugh 5-6;

8. Serum HCG negative in premenopausal women ;

9. Ability to understand the study and sign informed consent.

Key exclusion Criteria:

1. Cervical esophageal carcinoma;

2. Patients who have been treated previously with anti-tumor therapy (including chemotherapy, radiotherapy, surgery, immunotherapy, etc.);

3. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of anti-PD-L1 antibody and chemotherapeutic drugs;

4. Active autoimmune diseases;

5. A history of allogeneic stem cell transplantation and organ transplantation;

6. A history of interstitial lung disease or non-infectious pneumonia;

7. Patients who cannot tolerate chemotherapy or surgery due to severe cardiac, lung, liver or kidney dysfunction, or hematopoietic disease or cachexia;

8. A history of immunodeficiency (including a positive HIV test result), or other acquired or congenital immunodeficiency diseases;

9. 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);

10. 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;

11. A history of malignancies other than esophageal cancer before enrollment, excluding non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.