Comparing two chemotherapy approaches for gastric cancer treatment
The Single-center Randomized Study "Comparison of Safety and Effectiveness of the First Line of Polychemotherapy and Polychemotherapy in Combination With PIPAC Sessions in Primary Gastric Cancer With Isolated Peritoneal Carcinomatosis.
This study is testing whether adding a special type of chemotherapy treatment called PIPAC to standard chemotherapy can help people with gastric cancer do better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nizhny Novgorod Regional Clinical Oncology Center Government |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Nizhny Novgorod) |
| Trial ID | NCT06313801 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a first-line polychemotherapy regimen compared to a combination of polychemotherapy and Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) sessions in patients with gastric cancer. Patients will undergo diagnostic laparoscopy to confirm peritoneal carcinomatosis before being randomized into two groups: one receiving standard chemotherapy and the other receiving a modified regimen with PIPAC. The study aims to assess treatment responses and potential surgical options based on the effectiveness of the therapies administered.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histologically verified gastric cancer and peritoneal carcinomatosis.
Not a fit: Patients with active infections, severe allergies, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced gastric cancer, potentially improving survival rates and quality of life.
How similar studies have performed: Other studies have shown promising results with similar chemotherapy approaches, but the combination with PIPAC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Availability of signed informed voluntary consent of the patient 2. Age ≥18 years and ≤75 years 3. ECOG ≤1 4. Histological verification of gastric cancer and esophageal-gastric junction Siewert III (adenocarcinoma, ring-cell carcinoma) 5. Her2-neu negative tumor status 6. The presence of a preserved informative block of the primary tumor in the histological archive of the NOCOD (performing a biopsy and/or providing archival material - with the consent of the patient) 7. Verified gastric cancer (adenocarcinoma, ring-cell carcinoma) with the presence of M1 (with the only manifestation of M1 in the form of - Cy+ in initial peritoneal lavage and/or peritoneal dissemination PCI \<16) 8. Peritoneal adhesion index PAI \<16 9. Absence of active infectious, mental diseases, pronounced allergic conditions, as well as other concomitant pathology that may interfere with the implementation of the therapeutic and diagnostic measures provided for in the protocol 10. Adequate organ function (evaluation by laboratory parameters at screening - evaluation of hemoglobin, neutrophils, platelets, AST, ALT, total bilirubin, urea, creatinine) 11. Consent of men and women with preserved childbearing potential to use highly effective methods of contraception. Exclusion Criteria: 1. Lack of informed voluntary consent of the patient 2. Age \<18 years and \>75 years 3. ECOG ≥2 4. Histological forms other than adenocarcinoma and ring-cell carcinoma of the stomach and esophageal-gastric junction Siewert III 5. Her2-neu positive tumor status 6. The absence of a preserved informative block of the primary tumor in the histological archive of the NOCOD 7. M1 with the exception of Cy+ in initial peritoneal lavage and/or peritoneal dissemination PCI \<16 (Distant metastases, including mts in supraclavicular, mediastinal, paraaortic (16 collector), ovarian metastases. Note - MTS in peripheral lymph nodes require a fine needle puncture with cytological examination for verification. In case of mts lesions of intracorporeal lymph nodes, the criteria of mts will be - dimensions of more than 15 mm along the short axis or mts-altered structure of the lymph node, regardless of size; PCI ≥16) 8. Peritoneal adhesion index PAI ≥16 9. Contraindications to performing diagnostic laparoscopy 10. Complicated primary tumor (bleeding, decompensated stenosis, dysphagia III-IV) if not corrected. 11. Decompensated concomitant pathology 12. Primary multiple tumors (except basal cell skin cancer and cervical cancer in situ - provided there are no signs of relapse of the disease) 13. Any specific antitumor treatment for stomach cancer and /or other malignant tumor in the anamnesis (except basal cell skin cancer and cervical cancer in situ - provided there are no signs of relapse of the disease) 14. Previous specialized treatment for stomach cancer 15. Known individual intolerance to drugs included in the protocol 16. Pregnancy, breast-feeding
Where this trial is running
Nizhny Novgorod
- Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary", 11/1, Delovaya street, Nizhny Novgorod, 603126 — Nizhny Novgorod, Russia (Recruiting)
Study contacts
- Study coordinator: Sergey Klimin
- Email: kliminsergey7@gmail.com
- Phone: +79875403280
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.