Gastric cancer or Gastroesophageal junction cancer Gastric cancer, Gastroesophageal junction cancer
Conditions
Interventions
Systemic chemotherapy
Chemotherapy is given with one of the following regimens:
SOX plus Trastuzumab plus Pembrolizumab 6 courses (up to 9 courses allowed)
CapeOX plus Trastuzumab plus Pembrolizuma
D005743, D060828,D000077594
gastrectomy, induction chemotherapy, nivolumab, pembrolizumab
Sponsors
Kurokawa Yukinori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adenocarcinoma has been diagnosed by histopathological examination. 2) Untreated cStage IV gastric cancer or esophagogastric junction cancer (esophageal infiltration length within 3 cm). 3) Have one of the following nonhealing factors (Patients with two or more non-curable factors are ineligible. If cy1 is identified, eligibility is limited to peritoneal dissemination.) Distant lymph node metastasis Peritoneal dissemination (P3 is not suitable only for P1 / P2 in the 12th edition of the Gastric Cancer Handling Regulations) Liver metastasis (up to 5 metastases, regardless ofsize, but limited to those that can be resected) Lung metastasis (limited to one side, all of which are judged to be resectable) Bone metastasis (limited to those that can be irradiated in one field when irradiating) Ovarian metastasis (both sides are acceptable) Adrenal metastasis (both sides are acceptable) 4) The age is between 20 and 85. 5) PS (ECOG) is 0 or 1. 6) Prognosis of 3 months or more is expected. 7) It is expected to be resistant to conversion surgery with gastrectomy. 8) Consent has been obtained from the person himself / herself regarding participation in the research. 9) The function of major organs is maintained.
Exclusion criteria
Exclusion criteria: 1) Have active double cancer (simultaneous double cancer / multiple cancers and metachronous double cancers / multiple cancers with a disease-free period of 5 years or less, but if topical treatment is curable or expected to survive for 3 years or more Registration is possible). 2) Patients who is HER2-positive and PD-L1 CPS less than 1 3) Previous treatment history of antiPD1 antibody, antiPDL1 antibody, antiPDL2 antibody, antiCD137 antibody or antiCTLA4 antibody or other antibody therapy or drug therapy for T cell control. 4) Has a history of gastrectomy (however, a history ofbypass surgery for oral ingestion is acceptable). 5) Have a history of active bacterial or fungal infections or tuberculosis. 6) Has a history of serious heart disease, heart failure, myocardial infarction or unstable angina within 6 months from the date of registration. 7) have diabetes with poor control. 8) be pregnant, breastfeeding or pregnant. 9) Has a history of autoimmune disease (collagen disease). 10) Has a history of severe interstitial pneumonia. 11) Has a history of organ transplantation. 12) A case of endoscopic stent insertion of tumor stenosis. 13) In addition, the attending physician has determined that it is not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| R0 resection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), progression-free survival (PFS), recurrence-free survival (RFS) in R0 resection cases, histological response rate, rate of adverse events, rate of postoperative complications | — |
Contacts
Public ContactYukinori Kurokawa
The University of Osaka Hospital
Outcome results
None listed