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

JRCT ID: jRCTs051220065

Registered date:22/07/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer or Gastroesophageal junction cancer
• Date of first enrollment: 04/10/2022
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Systemic chemotherapy
Chemotherapy is given with one of the following regimens:SOX plusNivolumab 6 courses (up to 9 courses allowed)
CapeOX plus Nivolumab 6 courses (up to 9 courses allowed)
FOLFOX plus Nivolumab 8 courses (up to 12 courses allowed)
Conversion surgery
Surgery should be performed within 56 days after 14 days after the last administration of anticancer drug.
For the primary gastric lesion, perform total gastrectomy with D2 or D1 + lymph node dissection, pyloric gastrectomy, or cardia gastrectomy, aiming for R0 resection. The reconstruction law is not stipulated.
In principle, distant metastatic lesions should be resected if R0 can be resected. However, if CR is determined by preoperative imaging, non-resectation is permitted.

Outcome(s)

• Primary Outcome: R0 resection rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kurokawa Yukinori
• Source(s) of Monetary Support: Japan Society of Clinical Oncology