Clinical trial · Interventional
Neoadjuvant Chemotherapy With PISOXO for Locally-invaded-gastric Cancer (LIGC)
Neoadjuvant Chemotherapy With Pressurized Intra Peritoneal Aerosol Chemotherapy(PIPAC) Plus SOX Plus Olaparib (PISOXO) for Locally-invaded-gastric Cancer (LIGC)
NCT04410887CI-TRIAL-00045338unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PIPAC+SOX+OLAPARIB | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PISOXO
- description
- 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
- interventionNames
- Drug: PIPAC+SOX+OLAPARIB
Primary outcomes (1)
- measure
- Pathological response rate
- timeFrame
- Upto three months after curative resection of the primary tumor
- description
- Total percentage of patients with pathological complete or sub-total tumor regression (TRG1a+1b) in the primary tumour
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.