Intraperitoneal paclitaxel added to standard systemic chemotherapy for gastric cancer with peritoneal metastases
Randomised Phase III Trial of First Line Intraperitoneal Paclitaxel and Systemic Therapy Versus Systemic Therapy Alone in Gastric Cancer Patients With Peritoneal Metastases - IPa-Gastric
This trial tests whether giving paclitaxel directly into the abdomen together with standard systemic chemotherapy helps people with gastric cancer that has spread to the peritoneum live longer than systemic chemotherapy alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 262 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Verona and 4 other locations) |
| Trial ID | NCT07304271 on ClinicalTrials.gov |
What this trial studies
This is an open-label, multicenter, randomized phase III trial in the first-line setting for patients with gastric or gastro‑oesophageal junction adenocarcinoma who have peritoneal metastases or persistent tumor‑positive peritoneal cytology. Participants are randomized to receive intraperitoneal paclitaxel plus standard systemic therapy or standard systemic therapy alone, with treatment continued until progression, unacceptable toxicity, investigator decision, death, or end of study. Staging laparoscopy with peritoneal cancer index (PCI) is required before enrollment, and patients are followed for survival and other clinical endpoints after stopping treatment. The primary endpoint is overall survival.
Who should consider this trial
Good fit: Adults (≥18) with biopsy‑confirmed gastric or gastro‑oesophageal junction adenocarcinoma and confirmed peritoneal metastases or persistent tumor‑positive peritoneal cytology, ECOG 0–1, adequate organ function, and life expectancy ≥3 months are ideal candidates.
Not a fit: Patients with significant comorbidities that preclude intraperitoneal or systemic chemotherapy, poor performance status (ECOG >1), non‑adenocarcinoma histology, or dominant distant metastases outside the peritoneum are unlikely to benefit.
Why it matters
Potential benefit: If successful, adding intraperitoneal paclitaxel could extend survival and improve control of peritoneal disease with acceptable added toxicity.
How similar studies have performed: Smaller phase I/II studies and regional series of intraperitoneal chemotherapy in gastric cancer have shown promising response rates and manageable toxicity, but robust phase III evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour * Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid * Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment. * Patients with tumour positive cytology (CYT+) without clinically manifest peritoneal metastases at baseline (PCI 0) staging laparoscopy can be included if they persist to be CYT+ after at least four cycles of systemic chemotherapy. * Adequate hematology assessment and serum chemistry * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Age of at least 18 years * Life expectancy of at least three months * Assurance that adequate anti-reproductive measures will be taken during study interventions when applicable Exclusion Criteria: * Comorbidity that does not allow treatment with ST or IP paclitaxel * Confirmed or suspected severe abdominal adhesions * Severe coagulation disorder which precludes surgical interventions * Distant metastases (including M1 lymph node metastases) other than peritoneal, with the specific exception of ovarian metastases * Symptomatic ascites already requiring drainage for palliation, or expected to require drainage in the short term * Peritoneal recurrence of gastric cancer diagnosed within 6 months after curative intent surgery * Previously received more than 2 cycles of palliative-intent systemic chemotherapy (with the specific exception of cytology positive patients without manifest peritoneal metastases) for the current gastric cancer (up to 2 cycles of first line chemotherapy is allowed). Perioperative chemotherapy within previous curative context is allowed * Another malignancy that can affect survival within the next three years * Known or suspected allergies against any product included in the trial interventions * DYPD deficiency * Pregnancy or recent delivery within 28 days postpartum or ongoing breastfeeding * Active sex-life without use of secure contraceptive method. * If the investigator considers the patient inappropriate for participation in the study for any other reason * Ongoing or recent participation (within 30 days) in a clinical trial with an investigational medicinal product
Where this trial is running
Verona and 4 other locations
- Azienda Ospedaliera Universitaria Integrata Verona — Verona, Italy (Not_yet_recruiting)
- Sahlgrenska University Hospital — Gothenburg, Sweden (Not_yet_recruiting)
- Örebro University Hospital — Örebro, Sweden (Not_yet_recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Not_yet_recruiting)
Study contacts
- Study coordinator: Magnus Nilsson, MD, Professor
- Email: magnus.nilsson@ki.se
- Phone: +46 8 123 800 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.