Clinical trial · Interventional
Neoadjuvant Systemic and Peritoneal Chemotherapy for Advanced Gastric Cancer
Neoadjuvant Systemic and Peritoneal Chemotherapy for Regionally Advanced Gastric Cancer With Minimal Peritoneal Disease
- 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)
Data demonstrating the efficacy of PIPAC in patients with regionally advanced gastric cancer with positive peritoneal cytology and/or minimal peritoneal disease is limited due to the relatively recent development of this technique and its historical preferential use in palliative patients with disseminated peritoneal metastasis. Existing data suggest PIPAC administered every six weeks in conjunction with standard treatment may work as an adjunct to conventional systemic neoadjuvant chemotherapy. PIPAC protocols have been established both for gastric cancer as well as other intra-abdominal malignancies and have a good safety profile. Given these promising findings, a study protocol is proposed herein to further investigate PIPAC for the treatment of a highly selected group of patients with regionally advanced gastric cancer (positive peritoneal cytology and/or minimal peritoneal disease).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Peritoneal Metastases | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin and Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant systemic and peritoneal chemotherapy
- description
- Standard neoadjuvant systemic and pressurised intraperitoneal aerosol chemotherapy
- interventionNames
- Drug: Doxorubicin and Cisplatin
Primary outcomes (1)
- measure
- Feasibility and safety of combined neoadjuvant systemic chemotherapy and pressurised intraperitoneal aerosol chemotherapy (PIPAC)
- timeFrame
- 2 years
- description
- Barrier and mitigating factors or the provision of combined neoadjuvant systemic chemotherapy and PIPAC will be assessed. Safety of this intervention in terms of risks to patients and staff will also be evaluated.
Secondary outcomes (4)
- measure
- Tumour regression
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Gastric adenocarcinoma (Tx, Nx) 1,2,3 * Peritoneal cytology +ve or PCI ≤ 3 * No solid organ metastasis 2 * HER2 -ve * Male/female * Treatment naïve * BMI ≥ 18.5 kg/m2 or ≤ 40 kg/m2 * WHO performance status ≤ 1 * Dysphagia score ≤ 2 * Informed written consent Exclusion Criteria: * PCI ≥ 4 * Solid organ metastasis * Positive lymph node disease beyond field of D2 lymphadenectomy * Peritoneal adhesions precluding complete laparoscopy * Ascites (greater than trace amount) * Malignant pleural effusion * Mechanical bowel obstruction (with the exception of gastric outlet obstruction) * HER2 +ve * Patients eligible for immunotherapy * Uncontrolled co-morbidity * single/multiple organ failure * BMI \< 18.5 kg/m2 or \> 40 kg/m2 * WHO performance status \> 1 * Dysphagia score \> 2 * Contraindication to chemotherapy * Pregnancy or breastfeeding * Haemoglobin \<90 g/dL uncorrected with blood transfusion
References
Publications (0)
Data not yet available