A Study of Anti-PD-L1 Antibody in Neoadjuvant Chemotherapy of Esophageal Squamous Cell Carcinoma.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-18

Study Completion Date

2023-07-15

Brief Summary

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

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Detailed Description

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Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PD-L1 group

All patients will receive 16 cycles of anti-PD-L1 antibody (5mg/kg, IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).

Group Type EXPERIMENTAL

anti-PD-L1 antibody

Intervention Type DRUG

Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.

albumin bound paclitaxel

Intervention Type DRUG

Patients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .

cisplatin

Intervention Type DRUG

Patients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.

radical resection of esophageal carcinoma

Intervention Type PROCEDURE

Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.

placebo group

All patients will receive 4 cycles of placebo ( IV, every 3 weeks) , concurrently with 4 cycles of albumin-bound paclitaxel and cisplatin (albumin-bound paclitaxel 125mg/m2 on days 1, 8 and cisplatin 75 mg/m2 on day 1 every 3 weeks).

Group Type PLACEBO_COMPARATOR

albumin bound paclitaxel

Intervention Type DRUG

Patients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .

cisplatin

Intervention Type DRUG

Patients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.

placebo

Intervention Type DRUG

Patients will receive 4 cycles of placebo IV on day 1 every 3 weeks.

radical resection of esophageal carcinoma

Intervention Type PROCEDURE

Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.

Interventions

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anti-PD-L1 antibody

Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.

Intervention Type DRUG

albumin bound paclitaxel

Patients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .

Intervention Type DRUG

cisplatin

Patients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.

Intervention Type DRUG

placebo

Patients will receive 4 cycles of placebo IV on day 1 every 3 weeks.

Intervention Type DRUG

radical resection of esophageal carcinoma

Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.

Intervention Type PROCEDURE

Other Intervention Names

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ZKAB001 Socazolimab Injection ABRAXANE

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 to 75 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) ≥ 3.0×109/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 ≥60 mL/min;
6. INR ≤ 1.5, PT≤ 1.5×ULN;
7. Cardiac function: ≤I, pulmonary function: FEV1 \>1.2L, FEV1% \>40%, liver function: Child-Pugh 5-6;
8. Serum HCG negative in premenopausal women ;
9. Ability to understand the study and sign informed consent.

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;
12. Lymph node metastasis in neck, supraclavicular, abdominal cavity, retroperitoneum and pelvic cavity (except paracardial and left gastric lymph nodes).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No