Intraperitoneal paclitaxel added to standard systemic chemotherapy for gastric cancer with peritoneal metastases
Official title: 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
Run by Karolinska University Hospital · NCT07304271 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 262 (estimated) |
| Sponsor | Karolinska University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Verona and 6 other locations) |
| Status | Recruiting |
| Started | November 5, 2025 |
| Main results expected | January 31, 2031 |
| Study ends | January 31, 2031 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT07304271 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Karolinska University Hospital
Stockholm, Sweden Recruiting -
Uppsala University Hospital
Uppsala, Sweden Recruiting -
Azienda Ospedaliera Universitaria Integrata Verona
Verona, Italy Not yet recruiting -
Amsterdam University Medical Center
Amsterdam, Netherlands Not yet recruiting -
Sahlgrenska University Hospital
Gothenburg, Sweden Not yet recruiting -
Skane University Hospital
Lund, Sweden Not yet recruiting
Show 1 more location
-
Örebro University Hospital
Örebro, Sweden Not yet recruiting
Study contacts
- Study coordinator: Magnus Nilsson, MD, Professor
- Email: magnus.nilsson@ki.se
- Phone: +46 8 123 800 00
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Anti-PD-1 with chemotherapy and intraperitoneal nab-paclitaxel for untreated advanced gastric cancer with ascites
This study tests whether adding anti-PD-1 therapy to standard chemotherapy plus intraperitoneal nab-paclitaxel can help patients with untreated advanced gastric cancer and malignant ascites.
-
Myocardial Perfusion and Tissue Characterization with Photon-Counting CT in TAVI Patients
This study tests whether photon-counting CT can measure heart blood flow and tissue properties as well as MRI in patients planning a TAVI procedure.
-
HBOT for late radiation tissue injury: who benefits and when
This study follows adults with late radiation injury of the bladder or bowel who were treated with hyperbaric oxygen therapy to see who benefits most and when to start treatment.
-
Immune therapy with rituximab to restore ovarian function and fertility in autoimmune premature ovarian insufficiency
This trial will test whether the immune drug rituximab can restore ovarian function and improve fertility for women with autoimmune premature ovarian insufficiency.
-
Catheter ablation vs optimized medical care for very elderly with atrial fibrillation
In people aged 78 and up with AF, this study tests whether catheter ablation can help by comparing it to tailored medical therapy, using a wearable rhythm monitor to track AF over time.
-
Fatigue and thinking problems after allogeneic stem cell transplant (synapse damage or brain GVHD)
This project uses PET scans and spinal fluid samples to try to find why people who had an allogeneic stem cell transplant have persistent fatigue and thinking problems.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.