Neoadjuvant Chemotherapy With PISOXO for Locally-invaded-gastric Cancer (LIGC)

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to compare the safety and efficacy of PIPAC+SOX+OLAPARIB for locally-invaded-gastric cancer (LIGC) patients in China. To obtain preliminary results for designing a new phase II/III randomized controlled trial.

Detailed Description
-----------------
Peritoneal metastases is the main cause of relapse and death after surgery in patients with serosa positive or locally-invaded-gastric cancer (LIGC). Recent researches showed that PIPAC and Olaparib are effective to control peritoneal metastases in different malignant diseases but it has not been tested for gastric cancer patients. The main purpose of this study is to compare the safety and efficacy of PIPAC+SOX+OLAPARIB for locally-invaded-gastric cancer (LIGC) patients in China. To obtain preliminary results for designing a new phase II/III randomized controlled trial.

Official Title
-----------------
Neoadjuvant Chemotherapy With Pressurized Intra Peritoneal Aerosol Chemotherapy(PIPAC) Plus SOX Plus Olaparib (PISOXO) for Locally-invaded-gastric Cancer (LIGC)

Conditions
-----------------
Stomach Cancer, Gastric Cancer

Intervention / Treatment
-----------------
* Drug: PIPAC+SOX+OLAPARIB


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PISOXO<br>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 | Drug: PIPAC+SOX+OLAPARIB<br>* SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day OLAPARIB Day 1-14: Olaparib 300mg BID PO<br>* Other names: Chemotherapy;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological response rate | Total percentage of patients with pathological complete or sub-total tumor regression (TRG1a+1b) in the primary tumour | Upto three months after curative resection of the primary tumor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Overall survival (OS): Time from randomization to death from relapse | Five years | 
| Disease free survival (DFS) | Time from randomization to relapse of disease | Three years |