Clinical Trials /

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

NCT03950271

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: HNGC-005
  • NCT ID: NCT03950271

Conditions

  • Gastric Cancer

Interventions

DrugSynonymsArms
SHR-1210 Combined With Trastuzumab , Oxaliplatin and CapecitabineSHR-1210+ Trastuzumab + Oxaliplatin + Capecitabine

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
SHR-1210+ Trastuzumab + Oxaliplatin + CapecitabineExperimentaltrastuzumab + 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.
  • SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine

Eligibility 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.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Disease Free Survival(DFS)
Time Frame:up to 2 year
Safety Issue:
Description: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

Measure:Objective Response Rate (ORR)
Time Frame:up to 2 year
Safety Issue:
Description:Defined as the proportion of patients with a documented complete response, and partial response (CR + PR )
Measure:Overall survival(OS)
Time Frame:up to 2 year
Safety Issue:
Description:From date of randomization until the date of death from any cause
Measure:pathological complete response (pCR) rate
Time Frame:up to 2 year
Safety Issue:
Description:the rate of no residual invasive cancer, or only carcinoma in situ in both the excised breast and axillary lymph node

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Henan Cancer Hospital

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