Clinical trial: Study of Perioperative Chemotherapy Combined With Tirelizumab and Trastuzumab in the Treatment of GC/EGC (NCT04819971)

Eligibility criteria:
Key Inclusion Criteria:

          -  provide archive tumor tissue samples or accept fresh tumor tissue biopsy(Sample
             requirements are: formalin-fixed and paraffin-embedded wax blocks of tumor tissue or
             at least 20 unstained tumor specimen slides).

          -  assessed by the surgery can be removed, histology/confirmed HER2 positive cytology and
             the integration of a stomach esophagus carcinoma.

               -  CT2-4CN any C M0 or T any CN +M0, AJCC/UICC TNM staging of gastric cancer (8th
                  edition).

               -  The HER2 receptor protein status was assessed by immunohistochemistry (IHC) and
                  fluorescence in situ hybridization (FISH) using the following methods.Tumors with
                  an IHC 3+ score are considered HER2-positive.Patients with immunohistochemical 2+
                  tumors were given FISH tests to determine FISH positive samples.

               -  Abdominal computed tomography (CT), abdominal, pelvic, and/or echo-endoscopy were
                  performed 2 weeks before surgery to assess resectability.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.

          -  have no received no any anti-tumor treatment, including surgery, chemotherapy,
             targeted therapy, immune therapy.

          -  Adequate organ function (No blood transfusion or hematopoietic stimulating factor
             therapy was received within 14 days. Absolute neutrophil count (ANC) ≥1.5×109/L
             Platelet count ≥75×109/L Hemoglobin ≥80 g/L. Serum total bilirubin ≤1.5×ULN. total
             bilirubin must be <3×ULN) Prothrombin time/international normalized ratio (PT/INR)
             ≤1.5×ULN and activated partial thromboplastin time (aPTT) ≤1.5×ULN.Aspartate
             transaminase (AST) and alanine aminotransferase (ALT) ≤3×ULN. For subjects with liver
             metastases, AST and ALT must be ≤5×ULN for subjects with liver metastases. Creatinine
             clearance rate (Ccr) ≥50ml/min（according to the Cockcroft-Gault formula）. Urine
             protein qualitative≤1+ ;Or urinary protein qualitative ≥2+, 24 hours urinary protein <
             1g)

        Key Exclusion Criteria:

          -  A history of any other malignancy in the past 5 years (except carcinoma in situ or
             basal cell carcinoma of the skin or squamous cell carcinoma of the skin)

          -  Received other unmarketed investigational drug or therapy within 4 weeks prior to
             initial investigational drug use.

          -  A major organ surgery (excluding needle biopsy) or significant trauma occurred within
             4 weeks prior to initial investigational drug use.

          -  Requires systemic treatment with either corticosteroids (>10 mg daily prednisone
             equivalents) or other immunosuppressive medications within 14 days of study drug
             administration to treat a current condition.

        Exceptions include: topical, ocular, intraarticular, intranasal, and inhaled
        glucocorticoids;Short-term use of glucocorticoids for preventive treatment (e.g. to prevent
        contrast allergy)

          -  Use of immunoregulatory drugs, including but not limited to thymosin, interleukin-2,
             interferon, etc., within 14 days prior to initial use of the study drug.

          -  Has been administered a live vaccine within 4 weeks prior to Cycle1 Day 1.

          -  Previous recipient of allogeneic hematopoietic stem cell transplantation or organ
             transplantation.

          -  Previous adverse reactions to other medications have not recovered to CTCAE 5.0 level
             ≤1 (Other toxicities, such as hair loss, were not considered to pose a safety risk).

          -  Symptomatic peripheral neuropathy was evaluated as > 2 with CTCAE 5.0.

          -  Has central nervous system metastases or meningeal metastases.

          -  Inability to swallow medications orally, or other gastrointestinal diseases (such as
             total intestinal obstruction, etc.) that may affect the absorption of oral
             medications.

          -  Patients who had an active infection within 1 week prior to the first use of the study
             drug and who currently require systemic anti-infective therapy.

          -  has a history of alcohol or drug abuse or dependence.

          -  Known history of Human Immunodeficiency Virus (HIV).

          -  Untreated chronic hepatitis B viral (HBV) infection or chronic HBV carrier with HBV
             DNA ≥200 IU/mL (or 1000 copies/mL),prophylaxis antiviral therapy other than interferon
             is allowed ,or active hepatitis C virus (HCV) should be excluded.

          -  Current patients with interstitial lung disease.

          -  Has a history of severe cardiovascular and cerebrovascular disease, including but not
             limited to: has serious heart rhythm or abnormal conduction;Acute coronary syndrome,
             congestive heart failure, aortic dissection, stroke, or other grade 3 or higher
             cardiovascular and cerebrovascular events occurred within 6 months prior to D1 ;New
             York heart association (NYHA), cardiac function class II or higher and left
             ventricular ejection fraction (LVEF) < 50%; clinical uncontrol of high blood pressure.

          -  Patients with active, or previous and recurrent autoimmune diseases (such as systemic
             lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) were excluded from
             patients with clinically stable autoimmune thyroid disease.

          -  Grade 3 or higher arteriovenous thromboembolism events or bleeding events occurred
             within 6 months prior to the first use of the study drug;Or present with grade ≥2
             bleeding or factors determined by the investigator to have a higher blood risk (such
             as active gastrointestinal ulcer or esophageal varicose veins or tumor invasion of
             major blood vessels).

          -  Gastrointestinal perforation, abdominal fistula or intraperitoneal abscess occurred
             within 6 months prior to the first use of the study drug;Or a risk factor for cavity
             perforation/fistula formation (e.g., tumor infiltration of the outer wall of the
             cavity wall) currently identified by the investigator.

          -  Patients who allergies to the study drugs.

          -  People with mental disorders or poor compliance.

          -  Women who are pregnant or lactating.

          -  The investigator considers the subject to have a history of other serious systemic
             disease or for other reasons unsuitable for participation in this clinical study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands.

Patient description (patient's own words): I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated...

Does the patient match the trial criteria? Entailment