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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04460066
Recruitment Status : Not yet recruiting
First Posted : July 7, 2020
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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 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.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Drug: anti-PD-L1 antibody Drug: albumin bound paclitaxel Drug: cisplatin Drug: placebo Procedure: radical resection of esophageal carcinoma Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase Ib/II Clinical Study of Anti-pd-l1 Monoclonal Antibody Injection (ZKAB001) in Perioperative Treatment of Esophageal Squamous Cell Carcinoma.
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2023

Resource links provided by the National Library of Medicine


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 6 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 Name: ZKAB001

Drug: albumin bound paclitaxel
Patients will receive 6 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .
Other Name: ABRAXANE

Drug: cisplatin
Patients will receive 6 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 6 cycles of placebo ( IV, every 3 weeks) , concurrently with 6 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 6 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .
Other Name: ABRAXANE

Drug: cisplatin
Patients will receive 6 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.

Drug: placebo
Patients will receive 6 cycles of placebo IV 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.




Primary Outcome Measures :
  1. major pathologic response rate [ Time Frame: One week after surgery. ]
    The rate of pathologic 1a and 1b after neoadjuvant chemotherapy.


Secondary Outcome Measures :
  1. progression free survival [ Time Frame: From 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 progression free survival of the whole group.

  2. disease free survival [ Time Frame: From date of surgery 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 disease free survival of the whole group.

  3. overall survival [ Time Frame: From 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.

  4. R0 resection rate [ Time Frame: One week after surgery. ]
    The R0 resection rate of esophagectomy.

  5. treatment-related adverse events rate [ Time Frame: From the enrollment to 90 days later of the last chemotherapy. ]
    The incidence rate of treatment-related adverse events of the whole group assessed by CTCAE v5.0.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04460066


Contacts
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Contact: SHUGENG GAO, MD 86-010-87788530 gaoshugeng@vip.sina.com
Contact: YONG LI, MD 86-010-87788530 liyongdoctor@126.com

Locations
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China, Beijing
Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Lee's Pharmaceutical Limited
Investigators
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Study Director: SHUGENG GAO, MD Chinese Academy of Medical Sciences and Peking Union Medical College
Additional Information:
Publications:
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Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT04460066    
Other Study ID Numbers: ZKAB001-LEES-2020-02
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lee's Pharmaceutical Limited:
esophageal cancer
immunotherapy
Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antibodies
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs