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A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

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ClinicalTrials.gov Identifier: NCT03958890
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date August 7, 2020
Actual Study Start Date  ICMJE June 19, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
PFS [ Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years ]
Progression-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • OS [ Time Frame: from the date of first dose unitl the date of death from any cause,assessed up to 2 years ]
    Overall survival (OS)
  • PFS [ Time Frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years ]
    Progression-free survival (assessed by independent radiological review committee (IRRC) based on iRECIST,by the investigators based on RECIST v1.1))
  • ORR [ Time Frame: up to 2 years ]
    Objective response rate (assessed by independent radiological review and the investigators based on RECIST v1.1))
  • Duration of response [ Time Frame: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years ]
    Duration of response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Official Title  ICMJE A Randomized, Double-blind, Multicenter, Phase III Clinical Trial Comparing HLX10 (Recombinant Anti-pd-1 Humanized Monoclonal Antibody Injection) With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
Brief Summary This study is a randomized, double-blind, multi-center, phase III clinical study comparing the clinical efficacy and safety of HLX10 or placebo combined with chemotherapy in first-line treatment of locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: HLX10 100 mg in 10 ml Injection
    3mg/kg IV(HLX10+cis-platinum+5FU)
  • Drug: Placebos
    3mg/kg IV(placebo+cis-platinum+5FU)
Study Arms  ICMJE
  • Experimental: HLX10
    Intervention: Drug: HLX10 100 mg in 10 ml Injection
  • Placebo Comparator: placebo
    Intervention: Drug: Placebos
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019)
489
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who meet all of the following criteria are allowed to be enrolled into this study:

    • Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
    • Age ≥ 18 years and ≤ 75 years when ICF is signed;
    • Never received systemic anti-tumor drug therapy before.Exception: for patients who have received neoadjuvant/adjuvant treatment, the time from the last treatment to recurrence or progression can be screened for more than 6 months;For patients who have received radical concurrent chemoradiotherapy or radiotherapy for esophageal cancer, the time from the last chemotherapy/radiotherapy to the recurrence or progression time is more than 12 months.
    • According to the curative effect evaluation criteria in solid tumors (RECIST) v1.1, assessed by the center image with at least one measurable lesions (such as esophageal cavity structure not as measurable lesions), measurable lesions should be not received radiotherapy, etc (lesions located in the usual radiation area, if confirm progress, can also be selected as the target lesion);
    • PD-L1 positive subjects (CPS 1%).The subject must provide tumor tissue for pd-l1 expression level determination;
    • Within 7 days before the first use of the study drug, ECOG: 0 ~ 1;
    • Expected survival 12 weeks;
    • The functions of the vital organs meet the following requirements (no blood transfusion, cytokine growth factor, or platelet raising drugs are allowed within 14 days before the first use of the study drugs); H. Absolute neutrophil count (ANC) ≥1.5 109/L I. platelet≥ 100 109/L; J. Hemoglobin≥ 9g/dL; K. Serum albumin≥ 3.0g/dL; L. Total bilirubin≤ 1.5 ULN, ALT, AST and/or ALP≤ 2.5 ULN;ALT and/or AST≤ 5 ULN in the presence of liver metastasis;If there is liver metastasis or bone metastasis ALP≤ 5 ULN; M. Serum creatinine ≤1.5 ULN or creatinine clearance > 60 mL/min (Cockcroft-Gault formula); N. APTT, INR and PT ≤1.5 ULN;
    • For fertile female subjects, the serum pregnancy test must be negative within 7 days before the first dose.With fertile women subjects, and the partner for childbearing age women of male subjects, needs during the therapy, and after the last use HLX10 / placebo at least 3 months and the last time to use at least 6 months after chemotherapy using an approved by the medical contraception (such as intrauterine device, the pill or condoms);
    • Subjects voluntarily participated in this study and signed the informed consent, with good compliance and follow-up.

Exclusion Criteria:

  • Subjects who meet any of the following criteria are not allowed to be enrolled in this study:

    • 1. BMI < 17.5kg /m2;
    • 2. A history of gastrointestinal perforation and/or fistula within 6 months prior to the first administration;
    • 3. Obvious invasion of tumor into adjacent organs (aorta or trachea) of esophageal lesions leads to high risk of bleeding or fistula;3. Subjects after endotracheal stent implantation;
    • 4. Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
    • 5. Previous allergies to monoclonal antibody, HLX10, 5-fu, cisplatin and other platinum drugs;
    • 6.Have received any of the following treatments: A. Previous treatment with anti-pd-1 or anti-pd-L1 antibodies; B. Have received any research drugs within 4 weeks before the first use of the study drugs; C. Be enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or a follow-up interventional clinical study; D. Receive the final anticancer treatment within 4 weeks before the first use of the study drug;Palliative radiotherapy for bone metastases was allowed and was completed 2 weeks before the first dose.Radiotherapy covering more than 30% of the bone marrow area is not allowed within 28 days before the first dose.

E. Subjects who require systemic treatment with corticosteroids (> 10 mg/ day prednisone therapeutic dose) or other immunosuppressive agents within 14 days prior to the first use of the study drug;In the absence of active autoimmune disease, inhalation or topical use of steroids is permitted, and the therapeutic dose of prednisone 10mg/ day is allowed.

F. Those who have received the anti-tumor vaccine or the live vaccine within 4 weeks before the first dose of the study drug; G. Have undergone major surgery within 28 days prior to the first use of the study drug. Major surgery in this study is defined as requiring at least 3 weeks of postoperative recovery time before being able to receive the surgery treated in this study.Tumor puncture or lymph node biopsy were allowed.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jing Huang (010)87788102 huangjingwg@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958890
Other Study ID Numbers  ICMJE HLX10-007-EC301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shanghai Henlius Biotech
Study Sponsor  ICMJE Shanghai Henlius Biotech
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Henlius Biotech
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP