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

Phase 1

• Conditions: Stomach Cancer; Gastric Cancer
• Interventions: Drug: PIPAC+SOX+OLAPARIB

• Registration Number: NCT04410887
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-05-28
• Last Update Submitted: 2020-05-28
• Study First Posted: 2020-06-01
• Last Update Posted: 2020-06-01
• Study Start: 2020-12
• Primary Completion: 2021-12
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PISOXO	PIPAC+SOX+OLAPARIB	1. st cycle of PIPAC during 1st laparoscopic exploration Three cycles of SOX 2. 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Disease free survival (DFS)	Three years	Time from randomization to relapse of disease
Overall survival (OS)	Five years	Overall survival (OS): Time from randomization to death from relapse

Trial Locations

Locations (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China