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This is a prospective one arm phase II clinical study to evaluate the efficacy and safety of TQB2450 (PD-L1 inhibitor), anlotinib combined with oxaliplatin and capecitabine in patients with unresectable locally advanced, recurrent or metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction.
Enrollment
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Volunteers
Inclusion criteria
Patients volunteered to participate in the study and signed the informed consent.
Age 18-75, both male and female.
Histology or cytology confirmed HER2/Neu negative (or HER2 / Neu status cannot be determined) non resectable locally advanced or metastatic gastric or esophageal union adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma and hepatoid adenocarcinoma).
The time from the end of previous (neoadjuvant) chemotherapy / adjuvant radiotherapy to recurrence was more than 6 months.
At least one measurable lesion according to RECIST 1.1, which should not be received local treatment such as radiotherapy. If the lesions located in the previous radiotherapy area are confirmed to have progressed and meet the RECIST 1.1 standard, they can also be selected as target lesions.
ECOG PS 0-1.
Expected survival ≥ 3 months.
Adequate organ function as indicated by the following screening laboratory values： Blood test criteria include：
Biochemical tests should meet the following standards:
Sufficient coagulation function was defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 fold ULN.
Exclusion criteria
Allergic to any test drug and its excipients, or with a history of severe allergy, or as a contraindication to the test drug.
Active or history of autoimmune disease .
Symptomatic / Asymptomatic brain metastases.
CT suggests definite ulcerative lesions or stool occult blood positive.
There was a history of abnormal bleeding one month before admission ( Except epistaxis ).
Prior allogeneic bone marrow transplantation or organ transplantation
Congenital pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia, or active pneumonia confirmed by CT.
HIV positive, active hepatitis B or C, active tuberculosis.
Uncontrolled cancer pain
Live attenuated vaccine was injected 4 weeks before the start of the study, or is expected to be injected during the trial or within 5 months after the end of the trial.
Have received PD-1 / PD-L1 antibody, CTLA-4 antibody, or other treatment for PD-1 / PD-L1 and / or VEGFR inhibitors, or have not recovered from adverse events caused by medication more than 4 weeks ago (i.e., have not recovered to ≤ level 1 or baseline level).
Systemic application of glucocorticoids or immunosuppressants within 2 weeks before the start of the trial (Note: inhaled glucocorticoids and corticosteroids are allowed).
Symptomatic central nervous system metastases and / or cancerous meningitis are known. Patients with a history of central nervous system metastasis or spinal cord compression can be enrolled if they have received definite treatment and have stable clinical manifestations 4 weeks after discontinuation of anticonvulsants and steroids before the first administration of the study.
Hormone contraindications.
Affect oral medications (e.g. inability to swallow, chronic diarrhea, intestinal obstruction, etc.).
Peripheral neuropathy ≥ NCI CTCAE 2.
Uncontrolled or symptomatic hypercalcemia.
Infections requiring antibiotics within 14 days before the start of the trial.
Chronic enteritis.
The load of liver metastasis is more than 50% of the whole liver volume.
Patients with bone metastases at risk of paraplegia.
Patients with any severe and / or uncontrolled disease, include:
Long-term unhealed wounds or fractures.
Subjects unable to receive peripherally inserted central catheter (PICC) .
Abnormal coagulation (INR>1.5 or APTT>1.5 ×ULN ), bleeding tendency or thrombolytic or anticoagulant therapy. Known to have inherited or acquired bleeding and thrombotic tendency, such as: hemophilia, blood clotting skills disorder, thrombocytopenia, hypersplenism, etc. Those who had significant coughing up blood 2 months before entering the study, or the daily volume of hemoptysis reached half a teaspoon (2.5 ml) or more. There were significant clinical bleeding symptoms or clear bleeding tendency within 3 months before entering the study, such as gastrointestinal bleeding, hemorrhagic gastric ulcer and baseline fecal occult blood ++ And above, or suffering from vasculitis, etc. Long term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥ 300 mg / day or clopidogrel ≥ 75 mg / day).
Have undergone major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the first dose of the study or expected major surgery during the study treatment period, or non-diagnostic surgery within 4 weeks before the start of the trial.
A history of gastrointestinal perforation and/or fistula in the 6 months prior to enrollment; or arterial/venous thrombotic events, such as cerebrovascular accidents (except for stable cerebral infarction evaluated by the investigator), deep vein thrombosis, and pulmonary Embolizer.
Clinically significant pleural and ascites, including any pleural and ascites that can be found on a physical examination, and any pleural and ascites that has been treated in the past or still needs treatment. Only those with a small amount of pleural and ascites on imaging but asymptomatic can be selected if the investigator evaluates that they do not require treatment.
Suffering from interstitial lung disease that requires steroid therapy.
Uncontrolled metabolic disorders or other non-malignant tumor organs or systemic diseases or cancer secondary reactions, which can lead to higher medical risks and/or uncertainty in survival evaluation.
Significantly malnourished patients.
Have a history of psychotropic drug abuse and can not quit or have mental disorders.
Have a history of immunodeficiency, including those who have tested positive for HIV or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
History of other primary malignancies, with the exception of the following: 1) Malignant tumors that have completely remitted for at least 2 years before enrollment and no other treatment is required during the study period; 2) Non-melanoma skin cancer or skin cancer that has been adequately treated and has no evidence of disease recurrence Malignant freckle; 3) Carcinoma in situ that has been adequately treated and has no evidence of disease recurrence.
Pregnant or lactating women.
According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
Participate in other trials within 30 days before the start of the trial, or plan to participate in other trials while the trial is in progress.
In case of repetition，enter the group under the most stringent conditions.
Primary purpose
Allocation
Interventional model
Masking
25 participants in 1 patient group
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Central trial contact
Ning Li, Doctor
Data sourced from clinicaltrials.gov
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