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Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC

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: NCT04342910
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Tracking Information
First Submitted Date  ICMJE April 9, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date November 18, 2020
Actual Study Start Date  ICMJE September 21, 2020
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
Overall Survival (OS) in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
OS was defined as the time from randomization to death due to any cause.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2020)
  • Overall Survival (OS) in All Participants. [ Time Frame: Up to 27 months ]
    OS was defined as the time from randomization to death due to any cause.
  • Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.
  • Time to Tumor Progression (TTP) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    TTP was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment in All Participants.
  • Time to Failure (TTF) in All Participants or in PD-L1 Positive Participants [ Time Frame: Up to 27 months ]
    TTF was defined as the time from randomization to treatment discontinuation caused by any reason.
  • Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.
  • Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    DOR was defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
  • Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to RECIST 1.1 based on investigator assessment.
  • Time to Response (TTR) According to RECIST 1.1 based on investigator assessment in All Participants or in PD-L1 Positive Participants. [ Time Frame: Up to 27 months ]
    TTR was defined as the time from randomization to the first documented evidence of CR or PR.
  • The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03. [ Time Frame: Up to 27 months ]
    The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v4.03.
  • Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities. [ Time Frame: Up to 27 months ]
    Proportion of dose suspension, dose reduction or dose discontinuation caused by treatment-related toxicities.
  • Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline [ Time Frame: Up to 27 months ]
    Proportion of anti-camrelizumab antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline
  • Serum concentration of camrelizumab [ Time Frame: Up to 27 months ]
    Serum concentration of camrelizumab
  • Plasma concentration of apatinib [ Time Frame: Up to 27 months ]
    plasma concentration of apatinib
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 Study to Evaluate the Efficacy and Safety of Camrelizumab and Apatinib in Patients With GC/GEJC
Official Title  ICMJE A Study of Camrelizumab (SHR-1210) Combined With Apatinib Versus Paclitaxel or Irinotecan in Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma Progressed After First-line Chemotherapy
Brief Summary This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line platinum-contained therapy. The primary study hypotheses are that camrelizumab (SHR-1210) combined with apatinib prolongs overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Drug: camrelizumab
    200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
    Other Name: SHR-1210
  • Drug: Apatinib Mesylate
    250 mg qd
  • Drug: Paclitaxel
    80 mg/m^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
  • Drug: Irinotecan
    180 mg/m^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.
Study Arms  ICMJE
  • Experimental: camrelizumab (SHR-1210) combined with apatinib
    Participants will receive camrelizumab on Day 1 and Day 15 of each 28-day cycle and apatinib mg/day up to 2 years.
    Interventions:
    • Drug: camrelizumab
    • Drug: Apatinib Mesylate
  • Active Comparator: Paclitaxel or Irinotecan
    Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle, or irinotecan on Days 1 and 15 of each 28-day cycle.
    Interventions:
    • Drug: Paclitaxel
    • Drug: Irinotecan
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: April 10, 2020)
550
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically- or cytologically-confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
  2. Confirmed metastatic or locally advanced, unresectable disease.
  3. Progression on or after prior first-line therapy containing any platinum/fluoropyrimidine or platinum/taxane doublet.
  4. Willing to provide tumor tissue for PD-L1 biomarker analysis.
  5. Human epidermal growth factor receptor 2 (HER-2/neu) status known and participants with HER2/neu positive tumors show documentation of previous treatment containing trastuzumab.
  6. ECOG performance status of 0 to 1.
  7. Life expectancy of more than 12 weeks.
  8. Signing the informed consent forms.
  9. Adequate bone marrow, liver and renal function.

Exclusion Criteria:

  1. Squamous cell or undifferentiated gastric cancer.
  2. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  3. Subjects with an active, known or suspected autoimmune disease. Patients with type I diabetes who are receiving a stable dose of insulin, hypothyroidism who only needs hormone replacement therapy, and skin diseases (such as eczema, vitiligo, or psoriasis) that do not require systemic treatment and do not have acute deterioration within 1 year before the screening period, are allowed.
  4. Clinically significant cardiovascular and cerebrovascular diseases.
  5. Subjects with high blood pressure who cannot be controlled well with antihypertensive drugs.
  6. Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency.
  7. Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within the first 6 months of randomization.
  8. Subjects who have previously received anti-PD-1 / PD-L1 monoclonal antibody, anti-CTLA-4 monoclonal antibody, and VEGFR small molecule inhibitor therapy.
  9. Prior systemic chemotherapy, radiotherapy and surgery within 4 weeks before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1.
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: Quanren Wang, Ph.D wangquanren@hrglobe.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04342910
Other Study ID Numbers  ICMJE SHR-1210-III-316
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 Jiangsu HengRui Medicine Co., Ltd.
Study Sponsor  ICMJE Jiangsu HengRui Medicine Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianming Xu, Ph.D Affiliated Hospital, Academy of Military Medical Sciences
PRS Account Jiangsu HengRui Medicine Co., Ltd.
Verification Date April 2020

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