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SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT03950271
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Henan Cancer Hospital

Brief Summary:
The aim of this study is to observe the efficacy and safety of immume checkpoint inhibitor PD-1 SHR1210 combined with Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine Phase 2

Detailed Description:
This study is a prospective, one-arm, phase II clinical study to evaluate the safety and efficacy of SHR-1210 in combination with trastuzumab plus oxaliplatin and capecitabine for HER2-positive locally advanced resectable gastric adenocarcinoma and gastroesophageal junction adenocarcinoma during the perioperative treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of PD1 Antibody (SHR-1210) Combined With Trastuzumab, Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SHR-1210+ Trastuzumab + Oxaliplatin + Capecitabine
trastuzumab + SHR-1210 + capecitabine + oxaliplatin for neoadjuvant chemotherapy 4-cycle.Then D2 radical surgery. The patients continued to receive capecitabine plus oxaliplatin for adjuvant therapy, and the total number of chemotherapy cycles was 8 cycles.
Drug: SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine
  1. Neoadjuvant chemotherapy: SHR-1210 (200mg, d1, q3w) + trastuzumab ( 8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks) + capecitabine (1000mg/m2 bid d2-15, q3w) + Oxaliplatin (130mg/m2, d2, q3w);4cycle
  2. postoperative adjuvant chemotherapy: Capecitabine (1000mg/m2 bid d1-14, q3w) + oxaliplatin (130mg/m2, d1, q3w);The total number of chemotherapy cycles is 8 cycles.




Primary Outcome Measures :
  1. Disease Free Survival(DFS) [ Time Frame: up to 2 year ]
    The time from the start of randomization to the first tumor recurrence/metastasis or the death of the subject for any reason


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 2 year ]

    Defined as the proportion of patients with a documented complete response, and partial response (CR

    + PR )


  2. Overall survival(OS) [ Time Frame: up to 2 year ]
    From date of randomization until the date of death from any cause

  3. pathological complete response (pCR) rate [ Time Frame: up to 2 year ]
    the rate of no residual invasive cancer, or only carcinoma in situ in both the excised breast and axillary lymph node



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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. Signed the informed consent form
  2. 18-75 years old
  3. Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma (cT4 or / and N+M0, MDT believes that perioperative treatment is required):

    1. No peritoneal metastasis in CT
    2. evaluated as a resectable lesion. Note: Whether there is a distant metastasis should be confirmed by CT or MR scan. If bone metastasis is suspected, a bone scan should be performed. If there is suspected peritoneal metastasis, a laparoscopy should be performed. If brain metastasis is suspected, CT or MR examination should be performed.
  4. Have not received cytotoxic chemotherapy or targeted therapy and local tumor resection
  5. HER2 immunohistochemistry 3+ and fluorescence in situ hybridization showed significant amplification
  6. ECOG≤1
  7. Tumor specimens that can be used to detect PD-L1 and MSI status can be provided. Detection of PD-L1 and MSI will be performed after enrollment. This test requires patients to provide paraffin-embedded biopsy specimens.
  8. White blood cells ≥ 4×109/L, platelets without blood transfusion ≥ 100×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L without granulocyte stimulating factor, hemoglobin ≥ 90 g/L
  9. bilirubin ≤ 1.5 times the upper limit of normal value, cereal grass and alanine aminotransferase ≤ 2.5ULN. If there is liver metastasis, the grass and alanine aminotransferase ≤ 5ULN.
  10. serum creatinine ≤ 1.5ULN, or GFR > 45 ml / min
  11. serum albumin ≥ 25 g / L (2.5 g / dL)
  12. INR or APTT ≤ 1.5 ULN
  13. Hepatitis B surface antigen positive patients need to detect hepatitis B DNA virus quantitative detection, only patients below the upper limit of normal detection can be enrolled, and long-term use ofanti-hepatitis B virus drugs

Exclusion Criteria:

  1. Allergic to any test drug and its excipients, or have a history of severe allergies, or a contraindication to test drugs
  2. Have a history of autoimmune disease or be active
  3. Previously received allogeneic bone marrow transplantation or organ transplantation
  4. Congenital pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or CT-confirmed active pneumonia
  5. HIV test positive
  6. Active hepatitis B or hepatitis C
  7. Active tuberculosis
  8. Uncontrolled cancer pain
  9. A live attenuated vaccine is injected within 4 weeks before the start of the study, or it is expected that a live attenuated vaccine will be injected within 5 months after the trial or the end of the trial.
  10. Previous use of immunotherapy, including CTLA4, anti-PD-1, or anti-PDL1 mAb
  11. Systemic application of glucocorticoids or immunosuppressants within 2 weeks prior to the start of the trial. Inhaled corticosteroids and mineralocorticoids are allowed
  12. Hormone use contraindications。
  13. severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina within 3 months before the start of the test
  14. Uncontrollable increase in blood pressure or elevated blood sugar
  15. History of other malignant tumors 5 years ago, except for cervical cancer in situ, non-melanoma skin cancer or stage I uterine cancer
  16. Known central nervous system metastasis
  17. ≥ NCI CTCAE Level 2 Peripheral Neuropathy
  18. serum albumin is less than 2.5 g/dL
  19. uncontrollable or symptomatic hypercalcemia
  20. Infections requiring antibiotics within 14 days prior to the start of the test
  21. chronic enteritis
  22. clinically significant active gastrointestinal bleeding
  23. Non-diagnostic surgery within 4 weeks prior to the start of the trial 24 There is evidence of the need to limit any other disease using the test drug

25. Participate in other tests within 30 days before the start of the test, or plan to participate in other tests during the test. Accept other experimental drugs within 28 days before the start of the test 26. Women who are pregnant or lactating, or women who are planning to become pregnant within 5 months of the end of treatment. Women of childbearing age are required to undergo a blood pregnancy test within 7 days prior to the start of the trial.


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): NCT03950271


Contacts
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Contact: Ning Li 13526501903 lining97@126.com

Sponsors and Collaborators
Henan Cancer Hospital
Investigators
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Principal Investigator: Suxia Luo Henan Cancer Hospital

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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03950271     History of Changes
Other Study ID Numbers: GCCG7
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: May 2019

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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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Oxaliplatin
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Capecitabine
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological