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A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03472365
Recruitment Status : Active, not recruiting
First Posted : March 21, 2018
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Condition or disease Intervention/treatment Phase
Gastric Cancer GastroEsophageal Cancer Biological: SHR-1210 Drug: Capecitabine Drug: Oxaliplatin Drug: Apatinib Phase 2

Detailed Description:
Approximately 110 participants will be assigned to SHR-1210 + capecitabine + oxaliplatin combination therapy (Cohort 1), or SHR-1210 + apatinib combination therapy (Cohort 2).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase 2 Study to Evaluate Safety and Efficacy of the Combination of SHR-1210 With Capecitabine + Oxaliplatin or Apatinib as First-line Treatment in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Cohort 1
Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus capecitabine 1000 mg/m^2 twice daily (BID) by continous oral adminstration for 14 days, followed by a recovery period of 7 days, plus oxaliplatin 130 mg/m^2, IV q3w; for 4-6 cycles followed by SHR-1210 plus apatinib 375 mg PO qd.
Biological: SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Other Name: Camrelizumab

Drug: Capecitabine
1000 mg/m^2 administered as continuous oral twice daily (BID) of each 3-week cycle.

Drug: Oxaliplatin
130 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle.

Drug: Apatinib
375 mg administered as continuous oral once daily (QD) of each 3-week cycle.

Experimental: Cohort 2
Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus apatinib 375 mg daily (QD) continous oral. Study treatment will be started on Day 1 of each 3-week cycle.
Biological: SHR-1210
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
Other Name: Camrelizumab

Drug: Apatinib
375 mg administered as continuous oral once daily (QD) of each 3-week cycle.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to approximately 6 months. ]
    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) per RECIST 1.1 [ Time Frame: Up to 24 months. ]
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.

  2. Duration of Response (DOR) per RECIST 1.1 [ Time Frame: Up to 24 months. ]
    For participants who demonstrate CR (disappearance of all target lesions) or PR (≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters), DOR is defined as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1 based on assessments by blinded independent central review or death due to any cause, whichever occurs first.

  3. Disease Control Rate (DCR) per RECIST 1.1 [ Time Frame: Up to 24 months. ]
    DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.

  4. Number of Subjects with treatment-related adverse events (AEs) [ Time Frame: Up to 24 months. ]
    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma of stomach or the esophagogastric junction (GEJ)
  • Age ≥ 18 years old, male or female
  • NO previous therapy for advanced/metastatic disease of GC/GEJ (including HER2 inhibitor). Subjects with previous adjuvant/neo-adjuvant therapy completed more than 6 months can be enrolled.
  • Has measurable disease per RECIST 1.1
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Group (ECOG) performance status of 0 to 1
  • Has adequate organ function
  • Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.

Exclusion Criteria:

  • Has known HER2-positive status
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody, or a VEGFR inhibitor.
  • Has known active central nervous system metastases.
  • Has received a live vaccine within 4 weeks prior to the first dose of study treatment
  • With any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
  • Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention.
  • Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.
  • Coagulation abnormalities (INR > 1.5 or APTT > 1.5×ULN), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.

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): NCT03472365


Locations
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China, Anhui
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China
China, Guangdong
The sixth affliated hospital of Sun Yat-Sen Unversity
Guangzhou, Guangdong, China, 510655
China, Heilongjiang
Harbin Tumor Hospital
Harbin, Heilongjiang, China
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
China, Hubei
Tongji Hospital of Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
China, Jiangsu
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
China, Jilin
Jilin Cancer Hospital
Changchun, Jilin, China
China, Shanxi
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi, China
China, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Lin Shen, MD Beijing Cancer Hospital
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03472365    
Other Study ID Numbers: SHR-1210-II-207
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Jiangsu HengRui Medicine Co., Ltd.:
PD-1
SHR-1210
Capecitabine
Oxaliplatin
Apatinib
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Oxaliplatin
Apatinib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors