Clinical trial: Conversion Therapy With Sintilimab Plus CAPOX in Patients With Unresectable Locally Advanced or Limited Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction (NCT04263870)

Eligibility criteria:
Inclusion Criteria:

          1. Histologic and/or cytologic diagnosis of unresectable locally advanced or limited
             metastatic adenocarcinoma of the stomach or esophagogastric junction.

          2. Metastatic lesions are resectable or can be controlled by local ablative procedure.

          3. Definition of limited metastatic status:

               1. abdominal, retroperitoneallymphnodemetastases only (eg,para-aortic, intra
                  aortic-caval, peripancreatic, or mesenterial lymph nodes).

               2. One incurable organ site with or without retroperitoneal lymph node metastases.
                  One incurable organ site metastases according to the following schema： -
                  Localized potentially operable peritoneal carcinomatosis or only cytology-
                  positive (Cy1) peritoneal lavage fluid without macroscopic peritoneal metastasis
                  .

                    -  liver metastasis, and the number of liver metastasis ≤ 3 those are
                       potentially resetabl.

                    -  unilateral or bilateral Krukenberg's tumors in the absence of macroscopic
                       peritoneal carcinomatosis.

                    -  unilateral or bilateral adrenal metastases

                    -  Extra-abdominal lymph node metastases such as supraclavicular or cervical
                       lymph node involvement.

          4. Tumor HER-2 is negative.

          5. Age 18-75, gender unlimited.

          6. Survival expectation ≥12 weeks.

          7. Eastern Cooperative Oncology Group (ECOG) 0 or 1.

          8. Not previously treated with any systemic treatment (including HER2 inhibitors), or who
             have metastasis 6 months after the end of adjuvant chemotherapy or neoadjuvant
             chemotherapy. (Note: the use of oxaliplatin in previous adjuvant or neoadjuvant
             therapy should not exceed 800 mg/m2, and the treatment-related toxicity must be
             restored to common terminology criteria for adverse events (CTCAE) level 1 of the
             National Cancer Institute [NCI] before randomization.).

          9. According to the recist1.1 standard, there is at least one measurable objective tumor
             focus. The maximum diameter of spiral CT must be ≥ 1cm, and the maximum diameter of
             normal CT or MRI must be ≥ 2cm, and it should be carried out within 28 days before
             enrollment.

         10. All eligible patients have adequate organ function. According to the following
             laboratory test results (no blood transfusion, G-CSF or other medical support
             treatment within 14 days before the drug administration). The laboratory test results
             within 1 week before the study drug administration meet the following conditions:
             (HGB≥90 g/L , PLT ≥75 × 10⁹ /L, WBC ≥ 3.0× 10⁹ /L, ANC ≥1.5× 10⁹ / L, TBI ≤1.5 times
             UNL, Cr≤1.5 times the UNL, ALT and AST ≤2.5 times UNL（5 times UNL )in case of liver
             metastasis.

         11. Subjects with active hepatitis B or active hepatitis C must receive antiviral
             treatment for at least 14 days before the administration of the first study drug, and
             pass the detection of hepatitis B virus (HBV) DNA titer (no more than 500 IU / ml or
             2500 copies [CPS] / ml) and hepatitis C virus (HCV) RNA (no more than the detection
             limit of the detection method), which can be included in the group test, and are
             willing to continue to receive effective antiviral treatment during the study period.

         12. Patients participate voluntarily and sign written informed consent

        Exclusion Criteria:

        1.Severe hepatorenal insufficiency or history of myocardial infarction (within 3 months).

        2.5-year history of other malignancies(except skin basal cell carcinoma, cervical carcinoma
        in situ).

        3.Subjects with active or previous autoimmune diseases or risks that may recur(eg：requiring
        immunosuppressive therapy for organ transplantation). However, subjects with type I
        diabetes, hypothyroidism requiring hormone replacement therapy only, or skin diseases
        without systemic treatment (such as vitiligo, psoriasis, or alopecia) were allowed to enter
        the group.

        4.Have had interstitial lung disease or noninfective pneumonia, etc. symptoms of the
        disease or previous lung history may hinder the assessment or management of lung toxicity
        related to the study drug.

        5.Before the first administration of the study drug and who had a history of active
        tuberculosis infection more than one year ago were considered suitable for inclusion if
        they were judged by the investigator to have no evidence of active tuberculosis at present.

        6.Severe uncontrolled medical disease or acute infection (fever above 38 ℃ caused by
        infection).

        7.The combination of serious internal and external diseases, affecting organ function, the
        researchers think it is not suitable to participate in this clinical trial.

        8.Pregnant or lactating women or fertile (men or women with menopause less than 1 year) are
        unwilling to take contraceptive measures.

        9.Patients with a long history of chronic diarrhea or complete intestinal obstruction.

        10.Subjects requiring systemic treatment with corticosteroids (> 10 mg / day equivalent of
        prednisone) or other immunosuppressive drugs within 14 days prior to administration of the
        study drug. Note: if there is no active autoimmune disease, it is allowed to use inhaled or
        local steroid hormone, or adrenaline replacement therapy with equivalent dose of prednisone
        ≤ 10 mg per day. Short term (< 7 days) use of glucocorticoids for prophylactic treatment
        (e.g. contrast agent allergy) or for treatment of non autoimmune diseases (e.g. delayed
        type hypersensitivity caused by contact allergens) is allowed.

        11.Have interstitial lung disease or noninfective pneumonia, etc. symptoms of the disease
        or previous lung history may hinder the assessment or management of lung toxicity related
        to the study drug.

        12.Subjects who have received any antibody / drug (such as anti-PD-1, anti-PD- L1,
        anti-CTLA-4, anti OX-40, anti-CD137, anti Tim-3, anti LAG-3 antibody, etc.) targeting
        T-cell co regulatory protein (immunocheckpoint).

        13.Subjects with a history of hypersensitivity or hypersensitivity to study drug
        components.

        14.unable to take oral medicine.

        15.Presence of immunodeficient disease or HIV infection.

        16.Patients not suitable for this clinical trial determined by the investigator
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.
Subject must be at most 75 Years

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