NCT05318794Not yet recruitingPhase 2
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 · Last updated 13 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 17 Mar 2022
- Start date
- Nov 2023
- Primary completion date
- Jul 2025
- Lead sponsor
- Imperial College London
- NCT number
- NCT05318794
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From Nov 2023 to the primary completion date, Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients eligible for immunotherapy
- Contraindication to chemotherapy
Other illness
- Positive lymph node disease beyond field of D2 lymphadenectomy
- Malignant pleural effusion
- single/multiple organ failure
Lab values
- Haemoglobin \<90 g/dL uncorrected with blood transfusion
Other
- PCI ≥ 4
- Solid organ metastasis
- Peritoneal adhesions precluding complete laparoscopy
- Ascites (greater than trace amount)
- Mechanical bowel obstruction (with the exception of gastric outlet obstruction)
- HER2 +ve
- Uncontrolled co-morbidity
- BMI \< 18.5 kg/m2 or \> 40 kg/m2
- WHO performance status \> 1
- Dysphagia score \> 2
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Imperial College London, Hammersmith Hospital Campus Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.