Phase II study of chemotherapy plus nivolumab followed by conversion surgery for Stage IV gastric cancer with a single non-curable factor

Phase 2

Recruiting

• Conditions: Gastric cancer or Gastroesophageal junction cancer; Gastric cancer, Gastroesophageal junction cancer; D013274

• Registration Number: JPRN-jRCTs051220065
• Lead Sponsor: Kurokawa Yukinori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1) Adenocarcinoma has been diagnosed by histopathological examination.
2) HER2 is negative.
3) Untreated cStage IV gastric cancer or esophagogastric junction cancer (esophageal infiltration length within 3 cm).
4) Have one of the following nonhealing factors (not eligible if two or more)
Distant lymph node metastasis (not suitable for No 16a2 / b1 only)
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)
5) The age is between 20 and 85.
6) PS (ECOG) is 0 or 1.
7) Prognosis of 3 months or more is expected.
8) It is expected to be resistant to conversion surgery with gastrectomy.
9) Consent has been obtained from the person himself / herself regarding participation in the research.
10) The function of major organs is maintained.

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) 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.
3) Has a history of gastrectomy (however, a history ofbypass surgery for oral ingestion is acceptable).
4) Have a history of active bacterial or fungal infections or tuberculosis.
5) Has a history of serious heart disease, heart failure, myocardial infarction or unstable angina within 6
months from the date of registration.
6) have diabetes with poor control.
7) be pregnant, breastfeeding or pregnant.
8) Has a history of autoimmune disease (collagen disease).
9) Has a history of severe interstitial pneumonia.
10) Has a history of organ transplantation.
11) A case of endoscopic stent insertion of tumor stenosis.
12) In addition, the attending physician has determined that it is not suitable for this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
R0 resection rate

Secondary Outcome Measures

Name	Time	Method
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