JPRN-jRCTs051230063
Recruiting
未知
Randomized controlled trial to evaluate efficacy of additional synbiotics to combination therapy with immune checkpoint Inhibitors for unresectable or recurrent gastric and esophageal cancer - CONCIERGE study
Kurokawa Yukinori0 sites244 target enrollmentJuly 4, 2023
ConditionsGastric cancer , esophageal cancer
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Gastric cancer , esophageal cancer
- Sponsor
- Kurokawa Yukinori
- Enrollment
- 244
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Gastric cancer histologically diagnosed as adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, poorly differentiated adenocarcinoma), signet ring cell carcinoma, mucinous carcinoma, or hepatoid adenocarcinoma.
- •Esophageal cancer histologically diagnosed as squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma, or basaloid carcinoma.
- •(2\) Subjects with unresectable advanced gastric cancer/esophageal cancer or recurrent gastric cancer/esophageal cancer who undergo ICI\+chemotherapy or ICI combination therapy, which is the first\-line treatment, as usual clinical practice.
- •\[1] In the case of unresectable advanced gastric cancer, those who satisfy both i) and ii) below.
- •i) Diagnosed as cStage IVB or pStage IV based on clinical or surgical findings. However, it does not include the case of stage IV only by peritoneal washing cytology (CY1\). Also, it does not include localized peritoneal dissemination or cases in which macroscopic cure was achieved by excision of para\-aortic lymph node metastasis.
- •ii) Non\-surgical cases judged not to be suitable for surgery based on clinical findings including diagnostic imaging, or surgical cases in which gastrectomy (including exploratory laparotomy) was performed but ended in R1/2 resection. However, cases with positive resection margins and positive peeled surfaces are not included. For those who underwent gastrectomy (including exploratory laparotomy) but ended up with R1/2 resection, more than 2 weeks had passed since the date of surgery.
- •\[2] In the case of recurrent gastric cancer, the following are satisfied.
- •Gastric cancer with recurrence after radical resection based on clinical findings (including imaging findings) or surgical findings.
- •However, the following cases are excluded.
- •i) Recurrent cases during adjuvant therapy such as TS1 or within 6 months after adjuvant therapy
Exclusion Criteria
- •(1\) Subjects with active multiple cancers (simultaneous multiple cancers and metachronous multiple cancers with a disease\-free period of less than 5 years. However, carcinoma in situ judged to be cured by local treatment and lesions equivalent to intramucosal carcinoma are not included in active double cancer).
- •(2\) Subjects with an indwelling gastrointestinal stent (esophageal stent, etc.)
- •(3\) Subjects with infectious diseases requiring systemic treatment.
- •(4\) Pregnant women, those who may become pregnant, or women who are breastfeeding.
- •(5\) Subjects with psychosis or psychiatric symptoms and judged to be difficult to participate in this study.
- •(6\) Subjects with poorly controlled diabetes.
- •(7\) Subjects with unstable angina pectoris (angina pectoris with onset or exacerbation within the last 3 weeks) or a history of myocardial infarction within 6 months.
- •(8\) Subjects with serious complications (renal failure, liver failure, interstitial pneumonia/pulmonary fibrosis).
- •(9\) Subjects with active bleeding.
- •(10\) Subjects with history of treatment with anti\-PD\-1 antibody, anti\-PD\-L1 antibody, anti\-PD\-L2 antibody, anti\-CD137 antibody, anti\-CTLA\-4 antibody, or other antibody therapy or drug therapy for the purpose of controlling T cells.
Outcomes
Primary Outcomes
Not specified
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