Neoadjuvant Chemotherapy With PISOXO for Locally-invaded-gastric Cancer (LIGC)
Stomach Cancer, Gastric Cancer
About this trial
This is an interventional treatment trial for Stomach Cancer
Eligibility Criteria
Inclusion Criteria:
- Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction.
- Clinical stage: cTNM: T4b and or N0-3 M0
- Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day)
- Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function.
- Written informed consent
Exclusion Criteria:
- Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia
- Distant metastases
- Locally advanced inoperable disease (Clinical assessment)
- Relapse of gastric cancer
- Prior chemo or radiotherapy
- Inclusion in another clinical trial
- Known contraindications or hypersensitivity for planned chemotherapy
Sites / Locations
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Experimental
PISOXO
st cycle of PIPAC during 1st laparoscopic exploration Three cycles of SOX nd cycle of PIPAC during 2nd laparoscopic exploration Surgery Three cycles of SOX +/-OLAPARIB PIPAC Intraperitoneal chemotherapy for PIPAC is Docetaxel Neoadjuvant Chemotherapy Patients will receive three cycles of a standard dose of Tegafur gimeracil oteracil potassium capsule (TGO) plus oxaliplatin (SOX) +Olaparib prior to curative gastrectomy. Adjuvant chemotherapy Three cycles of SOX +/- OLAPARIB will be given as postoperative chemotherapy. Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule (TGO) 80mg/M2 oral (twice daily) Repeated every 21st day OLAPARIB Day 1-14: Olaparib 300mg oral twice a day