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

Sponsor
Ruijin Hospital
Study ID
NCT04410887
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • PIPAC+SOX+OLAPARIB — DRUG
    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

Study Details

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.

Key Dates

Start date
Dec 31, 2020
Status verified
May 2020
Primary completion
Dec 31, 2021
Completion
Mar 31, 2022

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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

Primary Outcome Measure

Pathological response rate [ Time Frame: Upto three months after curative resection of the primary tumor ]

Central Contacts

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