The IPa-Gastric trial: Comparing Intraperitoneal Paclitaxel and Systemic Therapy versus Systemic Therapy alone in Gastric Cancer Patients with Peritoneal Metastasis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Karolinska University Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

5 Nov 2025 → ongoing

Decision date (initial)

2025-08-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

To compare overall survival (OS) for patients randomised to intraperitoneal (IP) paclitaxel and standard systemic therapy (ST) versus those randomised to standard ST only.

Secondary objectives 6

1. To assess toxicity in patients treated with IP paclitaxel.
2. To compare health-related quality-of-life (HRQoL) during treatment and follow-up between patients in the two treatment groups.
3. To compare progression-free survival (PFS), radiological progression of peritoneal carcinomatosis lesions, radiological progression of ascites, need for drainage of ascites or death, whichever occurs first, between the two treatment groups.
4. To compare radiological response of treatment on ascites present at baseline, between the two treatment groups.
5. To compare time from randomisation to first paracentesis of ascites between the two treatment groups.
6. To compare the proportion of patients a. considered resectable, b. actually resected, with curative intent surgery (conversion surgery) between patients in the two treatment groups.

Conditions and MedDRA coding

Gastric cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Gastric or gastro-oesophageal junction Siewert type II or III adenocarcinoma verified by biopsy or cytology from the primary tumour
2. Peritoneal metastasis verified by biopsy, or cytology from ascites or peritoneal wash fluid
3. Staging laparoscopy with assessment of peritoneal cancer index (PCI) performed less than four weeks before enrolment.
4. 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.
5. Adequate bone marrow function (neutrophil count >1500/mm3, hemoglobin >8.0 g/dl and platelet count >100 000/mm3).
6. Adequate liver function (bilirubin within 1.5x of the upper limit of normal, AST/ALT within 3x of upper limit of normal).
7. Adequate renal function (serum creatinine within1.5x of the upper limit of normal or Glomerular Filtration Rate via Cockcroft-Gault Formula>50mL.
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
9. Age of at least 18 years.
10. Life expectancy of at least three months.
11. Male participants are eligible to participate if they agree to the following requirements during the intervention period and for at least 6 months after the last dose of study intervention, which corresponds to the time needed to eliminate reproductive safety risk of the study intervention(s) plus an additional 90 days (a spermatogenesis cycle): o Refrain from donating sperm. PLUS either: • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR • Must agree to use contraception/barrier as detailed below. • Agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. • Use of an additional highly effective contraceptive method with a failure rate of <1% per year for a female partner of childbearing potential.
12. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: • Is not a WOCBP. OR • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), preferably with low user dependency during the intervention period and for at least 9 months after the last dose of study intervention, which corresponds to the time needed to eliminate any reproductive safety risk of the study intervention(s). As for participants using a highly effective method that is user dependent, this contraception method must be used together with a second effective method of contraception. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.

Exclusion criteria 15

1. Comorbidity that does not allow treatment with ST or IP paclitaxel.
2. 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 cancer disease.
3. Another malignancy that can affect survival within the next three years.
4. Known or suspected allergies against any product included in the trial interventions.
5. Known DPYD deficiency (including complete and partial deficiency).
6. Known MSI-H/dMMR phenotype.
7. Pregnancy or recent delivery within 28 days postpartum or ongoing breastfeeding.
8. Active sex-life without use of secure contraceptive method.
9. If the investigator considers the patient inappropriate for participation in the study for whatever reason.
10. Ongoing or recent participation (within 30 days) in a clinical trial with an investigational medicinal product.
11. Confirmed or suspected severe abdominal adhesions, for example after previous abdominal surgery, which do not allow effective IP paclitaxel treatment.
12. Distant metastases (including M1 lymph node mestastases according to AJCC 8th edition TNM classification) other than peritoneal, with the specific exception of ovarian, which are permitted.
13. Symptomatic ascites already requiring drainage for palliation, or expected to require drainage in the short term, i.e within the next three weeks (radiological ascites without significant symptoms is acceptable).
14. Gastric cancer peritoneal reccurence which is diagnosed within 6 months after curative intent surgery (patients with recurrence diagnosed 6 months or more after curative intent surgery may be included).
15. Severe coagulation disorder which precludes surgical interventions such as staging laparoscopies and SIPC placement

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival (OS), defined as time from randomisation to death from any cause.

Secondary endpoints 6

1. Toxicity/adverse Events (AE) according to CTCAE v5.0 in patients treated with IP paclitaxel.
2. HRQoL assessed using EORTC QLQ-C30 and EORTC OG-25 during treatment and follow-up.
3. Progression-free survival (PFS), defined as time from randomisation to first documentation of progression according to RECIST1.1, progression of peritoneal carcinomatosis index (PCI), radiological progression of ascites, need for drainage of ascites or death, whichever occurs first.
4. Radiological response of treatment on ascites present at baseline.
5. Quantifying the amount of ascites drained from the randomisation date to date of censoring, death or end of study.
6. Proportion of patients in each study arm, 1. Fulfilling the criteria for, 2. Undergoing, curative intent conversion surgery.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 8

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Karolinska University Hospital

Sponsor organisation

Karolinska University Hospital

Address

Halsovagen, Flemingsberg Flemingsberg

City

Huddinge

Postcode

141 86

Country

Sweden

Scientific contact point

Organisation

Karolinska University Hospital

Contact name

Magnus Nilsson

Public contact point

Organisation

Karolinska University Hospital

Contact name

Magnus Nilsson

Third parties 1

Locations

4 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 39 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications