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

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ruijin Hospital
• Treatments: Olaparib

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