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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04410887
• Other study ID #: DRAGON VI: PISOXO Phase I
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2020
• Est. completion date: March 2022

Study information

• Verified date: May 2020
• Source: Ruijin Hospital
• Contact: Birendra K Sah, Ph D
• Phone: 0086-13817516354
• Email: rjsurgeon[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Cancer
• Stomach Neoplasms

Intervention

Drug:
• PIPAC+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

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	Overall survival (OS): Time from randomization to death from relapse	Five years
Secondary	Disease free survival (DFS)	Time from randomization to relapse of disease	Three years