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

April 28, 2022 updated by: Lee's Pharmaceutical Limited

A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Study of Anti-pd-l1 Monoclonal Antibody Injection (ZKAB001) Combined Albumin Binding Paclitaxel, Cisplatin in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000
        • Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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.

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
Drug: anti-PD-L1 antibody
Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
Other Names:
  • ZKAB001
  • Socazolimab Injection
Drug: albumin bound paclitaxel
Patients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .
Other Names:
  • ABRAXANE
Drug: cisplatin
Patients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.
Procedure: radical resection of esophageal carcinoma
Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.
PLACEBO_COMPARATOR: 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).
Drug: albumin bound paclitaxel
Patients will receive 4 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .
Other Names:
  • ABRAXANE
Drug: cisplatin
Patients will receive 4 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.
Procedure: radical resection of esophageal carcinoma
Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.
Drug: placebo
Patients will receive 4 cycles of placebo IV on day 1 every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
major pathologic response rate
Time Frame: Two weeks after surgery.
The rate of pathologic 1a and 1b after neoadjuvant chemotherapy.
Two weeks after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R0 resection rate
Time Frame: Two weeks after surgery.
The R0 resection rate of esophagectomy.
Two weeks after surgery.
pathological complete response rate
Time Frame: Two weeks after surgery.
The rate of pathologic 1a after neoadjuvant chemotherapy.
Two weeks after surgery.
disease free survival
Time Frame: From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.
The 2-year disease free survival of the whole group.
From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.
disease free survival rate
Time Frame: From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.
The 2-year disease free survival rate of the whole group.
From the date of surgery until the date of death due to disease progression or the date of first documented disease progression whichever came first, assessed up to 24 months.
event free survival
Time Frame: From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
The 2-year event free survival of the whole group.
From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
event free survival rate
Time Frame: From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
The 2-year event free survival rate of the whole group.
From the date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
overall survival rate
Time Frame: From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
The 2-year overall survival rate of the whole group.
From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
overall survival
Time Frame: From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
The 2-year overall survival of the whole group.
From the date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
adverse events rate
Time Frame: From the date of randomization to 90 days after the last chemotherapy.
The incidence rate of treatment-related adverse events of the whole group assessed by CTCAE v5.0.
From the date of randomization to 90 days after the last chemotherapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lee's Pharmaceutical Limited

Investigators

  • Study Director: SHUGENG GAO, MD, Chinese Academy of Medical Sciences and Peking Union Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 18, 2020

Primary Completion (ACTUAL)

December 6, 2021

Study Completion (ANTICIPATED)

July 15, 2023

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

July 5, 2020

First Posted (ACTUAL)

July 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZKAB001-LEES-2020-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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