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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04410887
Other study ID # DRAGON VI: PISOXO Phase I
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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