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The Purpose of This Study is to Evaluate the Efficacy and Safety of Sintilimab in Combination With Xelox as Neoadjuvant Therapy for Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.

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: NCT04065282
Recruitment Status : Unknown
Verified February 2020 by jianghaiping, First Affiliated Hospital of Zhejiang University.
Recruitment status was:  Recruiting
First Posted : August 22, 2019
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
jianghaiping, First Affiliated Hospital of Zhejiang University

Brief Summary:
Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) as Neoadjuvant Therapy in patients With Resectable Locally Advanced Gastric Cancer

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Sintilimab Drug: Oxaliplatin Drug: Capecitabine Phase 2

Detailed Description:
This prospective, multicenter, single-armed, phase II study will evaluate efficacy and safety of Sintilimab in combination with Xelox (Oxaliplatin 130mg/m2 iv d1 Q3w and Capecitabine 1000mg/m2 po Bid d1-14 Q3W) as neoadjuvant therapy in patients with resectable locally advanced gastric or gastroesophageal adenocarcinoma(G/GEJ AC). Newly diagnosed, treatment naïve patients with resectable locally advanced gastric or G/GEJ AC will be eligible to receive up to 3 cycles of sintilimab plus Xelox regimen as neoadjuvant therapy. Following radical gastrectomy will be performed within one to four weeks since last dosing for patients with resectable cancer after radiological evaluation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: neoadjuvant chemotherapy sintilimab plus XELOX
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Single-armed, Phase II Study Evaluating Efficacy and Safety of Neoadjuvant Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.
Actual Study Start Date : August 6, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: neoadjuvant therapy with Sintilimab plus Xelox
3 cycles of neoadjuvant therapy: Sintilimab iv d1 Q3W, Oxaliplatin 130mg/m2 iv d1 Q3W, and Capecitabine 1000mg/m2 po Bid d1-14 Q3W
Drug: Sintilimab
3 cycles before radical surgery
Other Name: IBI308

Drug: Oxaliplatin
85mg/m2 Q3W, 3 cycles perioperation

Drug: Capecitabine
1000mg/m2 bid po D1~14 Q3W, 3 cycles perioperation




Primary Outcome Measures :
  1. Pathological complete response rate (pCR) [ Time Frame: after surgical resection (up to 12 weeks after first dosing) ]
    evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 3 cycles of neoadjuvant therapy.


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 9 to 12 weeks ]
  2. Tumor regression grade (TRG) [ Time Frame: after surgical resection (up to 12 weeks after first dosing) ]
  3. Disease free survival (DFS) [ Time Frame: every 90 days after resection, up to 2 years ]
  4. 1-year overall survival rate [ Time Frame: 1 years ]
  5. 2-year overall survival rate [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Overall survival (OS) [ Time Frame: up to 5 years ]
    The relation between overall survival and pathological response after neoadjuvant therapy of Sintilimab plus Xelox for gastric cancer

  2. PD-L1 expression, tumor infiltrating lymphocytes (TIL), etc. [ Time Frame: after surgical resection (up to 12 weeks after first dosing) ]
    The relation between treatment efficacy and biomarker in tumor tissue

  3. Cytokine (IL-6) [ Time Frame: up to 12 weeks after first dosing ]
    The relation between treatment efficacy and biomarker in peripheral blood

  4. immune cell subpopulation (CD3, CD4, CD8 lymphocytes ) [ Time Frame: up to 12 weeks after first dosing ]
    The relation between treatment efficacy and biomarker in peripheral blood



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven adenocarcinoma of the stomach.
  2. The primary tumor locates at stomach or esophagogastroesophageal ic junction.
  3. Clinical T3-4NxM0 disease, confirmed by enhanced contrast abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
  4. At least one measurable lesion.
  5. Resectable gastric or gastroesophageal cancer, judged by surgeons in this studyEligible and reasonably suitable for potentially curative resection
  6. ECOG performance status 0-1.
  7. Adequate organ function for chemotherapy and surgical treatment, as evaluated by laboratory tests.
  8. Written (signed) informed consent.
  9. Good compliance with the study procedures, including lab and auxiliary examination and treatment.
  10. Agree to use an approved contraceptive method during the treatment period, until 120 days after last dose of Sintilimab or 180 days after last dose of chemotherapy.

Exclusion Criteria:

  1. Unsectable primary tumor or any distant metastatic disease.
  2. Received any anti-cancer therapy for this disease, including radiation therapies, chemotherapies, immunotherapies, and Chinese traditional herb therapies.
  3. Clinical T1-2N0M0 disease, confirmed by CT/MRI or endoscopic ultrasonography.
  4. Active autoimmune disease or history of refractory autoimmune disease.
  5. History of any other malignant tumor within 2 years, excluding cured local tumor, such as resected skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or ductal carcinoma in situ (DCIS).
  6. History of gastrointestinal hemorrhage within 2 weeks before enrollment or patients with a high risk of hemorrhage.
  7. History of gastrointestinal perforation within 6 months before enrollment.
  8. Gastrointestinal obstruction, gastrointestinal dysfunction, or malabsorption syndrome that may affect the absorption of Capecitabine.
  9. Weight loss is greater than 20% within 2 months before enrollment.
  10. History of severe pulmonary disease, including but not limited to interstitial pulmonary disease, noninfectious pneumonitis, pulmonary fibrosis, acute pulmonary disease
  11. Uncontrolled systematic disease, including diabetes mellitus, hypertension, etc.
  12. Severe chronic or active infectious disease that needs systematic antibiotics, antifungal, or antiviral therapies.
  13. Untreated chronic hepatitis B, serum HBV DNA load higher than the lower threshold of the test, or HCV RNA positive.
  14. With any cardiovascular risk factors as follow:

    1. History of angina within 28 days before enrollment, defined as moderate pain affecting daily activities;
    2. History of symptomatic pulmonary embolism within 28 days before enrollment;
    3. History of acute myocardial infarction within 6 months before enrollment;
    4. History of NYHA class III/IV heart failure within 6 months before enrollment;
    5. History of grade 2 (Lown grading system) or menopause ventricular arrhythmias or history of supraventricular arrhythmias that needs treatment within 6 months before enrollment;
    6. History of cerebrovascular accident within 6 months before enrollment;
  15. grade 1 Peripheral neuropathy , excluding patients with only deep tendon reflex absence.]
  16. Known Dihydropyrimidine dehydrogenase (DPD) deficiency.
  17. Known allergic to any drug used in this study.
  18. History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
  19. Receiving corticosteroid (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding following therapies:

    1. steroid hormone replacement therapy (≤10mg/d);
    2. local steroid therapy;
    3. short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting
  20. Receiving attenuated vaccine within 4 weeks before enrollment.
  21. Receiving immunotherapy or other study drugs within 28 days before enrollment,
  22. History of receiving anti-PD-1, anti-PD-L1, anti-PD-L2, or any other T cell co-simulation or checkpoint inhibitor therapy.
  23. Receiving major surgery within 28 days before enrollment.
  24. For patients with uncontrolled epilepsy, central nervous system disease, or mental disorder, researchers should evaluate if the inform consent and/or the compliance would be affected by their disease.
  25. Any drug or alcohol abuse that would affect drug management or toxicity analysis.
  26. Pregnant or nursing female.

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): NCT04065282


Contacts
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Contact: Haiping Jiang, PhD 0571-87235896 jianghaiping75@163.com

Locations
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China
First Affiliated Hospital of Zhejiang University Recruiting
Zhejiang, China
Contact: haiping jiang, PhD    0571-87235896    lsteng@zju.edu.cn   
Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: jianghaiping, Associate cheif physician, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT04065282    
Other Study ID Numbers: CIBI308Y030
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents