Status:
UNKNOWN
Neoadjuvant Chemotherapy With PISOXO for Locally-invaded-gastric Cancer (LIGC)
Lead Sponsor:
Ruijin Hospital
Conditions:
Stomach Cancer
Gastric Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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 ne...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04410887
Start Date
December 1 2020
End Date
March 1 2022
Last Update
June 1 2020
Active Locations (1)
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1
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025