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

Primary Purpose

Stomach Cancer, Gastric Cancer

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

PIPAC+SOX+OLAPARIB

About this trial

This is an interventional treatment trial for Stomach Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

PISOXO

Arm Description

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

Outcomes

Primary Outcome Measures

Pathological response rate

Total percentage of patients with pathological complete or sub-total tumor regression (TRG1a+1b) in the primary tumour

Secondary Outcome Measures

Overall survival (OS)

Overall survival (OS): Time from randomization to death from relapse

Disease free survival (DFS)

Time from randomization to relapse of disease

Full Information

NCT ID

NCT04410887

First Posted

May 28, 2020

Last Updated

May 28, 2020

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04410887

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2020 (Anticipated)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stomach Cancer, Gastric Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PISOXO

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

PIPAC+SOX+OLAPARIB

Other Intervention Name(s)

Chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Pathological response rate

Description

Total percentage of patients with pathological complete or sub-total tumor regression (TRG1a+1b) in the primary tumour

Time Frame

Upto three months after curative resection of the primary tumor

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

Overall survival (OS): Time from randomization to death from relapse

Time Frame

Five years

Title

Disease free survival (DFS)

Description

Time from randomization to relapse of disease

Time Frame

Three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Birendra K Sah, Ph D

Phone

0086-13817516354

rjsurgeon@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhenggang Zhu, Ph D

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Birendra K Sah, PH D

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Chen Li, PH D

Organizational Affiliation

Ruijin Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Zhenggang Zhu, PH D

Organizational Affiliation

Ruijin Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Ruijin Hospital Shanghai Jiaotong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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