Gastric Cancer, Stomach Cancer
Conditions
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.
Interventions
DRUGPIPAC+SOX+OLAPARIB
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
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological response rate | Upto three months after curative resection of the primary tumor | Total percentage of patients with pathological complete or sub-total tumor regression (TRG1a+1b) in the primary tumour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Five years | Overall survival (OS): Time from randomization to death from relapse |
| Disease free survival (DFS) | Three years | Time from randomization to relapse of disease |
Countries
China
Contacts
Primary ContactBirendra K Sah, Ph D
Backup ContactZhenggang Zhu, Ph D
Outcome results
None listed