Neoadjuvant Chemotherapy With PISOXO for Locally-invaded-gastric Cancer (LIGC)
NCT ID: NCT04410887
Last Updated: 2020-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2020-12-31
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PISOXO
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
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Responsible Party
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BIRENDRA KUMAR SAH
Principal investigator
Principal Investigators
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Birendra K Sah, PH D
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Chen Li, PH D
Role: STUDY_DIRECTOR
Ruijin Hospital
Zhenggang Zhu, PH D
Role: STUDY_CHAIR
Ruijin Hospital
Locations
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Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Zhenggang Zhu, Ph D
Role: CONTACT
Other Identifiers
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DRAGON VI: PISOXO Phase I
Identifier Type: -
Identifier Source: org_study_id
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