Clinical trial · Interventional
The Efficacy of Surgical Treatment After Neoadjuvant Chemotherapy Plus Intraperitoneal Immunotherapy Versus Chemotherapy Alone for Patients With Positive Wash Cytology Gastric Cancer
Prospective Randomized Phase II Clinical Trial: the Efficacy of Surgical Treatment in Combinations With Intraperitoneal Immunotherapy and Systemic Chemotherapy in Patients With Gastric Cancer and Verified Free Cancer Cells
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether intraperitoneal immunotherapy (with interleykin-2 - human cytokine reaction activator) with systemic chemotherapy will be more effective than systemic chemotherapy alone in patients with gastric cancer and verified free cancer cells in abdominal cavity in improving the long term outcomes and overall survival of further surgical treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer, Metastatic | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant chemoimmunotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- neoadjuvant chemoimmunotherapy
- description
- Patients with gastric cancer and verified free cancer cells who receive 1 course of intraperitoneal immunotherapy with interleykin-2 + 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -\> M0) surgical treatment will be performed.
- interventionNames
- Procedure: neoadjuvant chemoimmunotherapy
- type
- NO_INTERVENTION
- label
- neoadjuvant chemotherapy
- description
- Patients with gastric cancer and verified free cancer cells who receive 3 courses of systemic chemotherapy (Cisplatin + 5-FU). In case of downstaging (M1 -\> M0) surgical treatment will be performed.
Primary outcomes (1)
- measure
- Overall 2-year survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG 0-2 * Histologically proven gastric cancer T2-3 N+, T4a with any N (0,+) with free cancer cells in the abdominal cavity and no macroscopic canceromathosis and no other distant metastases (TNM classification 7th edition) * Histological forms: gastric adenocarcinoma and signet ring cancer * Blood characteristics (creatinine \<150 mg/l, total bilirubin \< 50 mkmol/l, neutrophils \< 1500/mkl, hemoglobin \>90 g/l, thrombocytes \> 100000/mkl) Exclusion Criteria: * Clinically apparent distant metastasis (besides free cancer cells) * Synchronic or metachronic malignant tumors * Previous systemic or surgical or combined therapy for gastric cancer * Complications of gastric cancer (obstruction 0-1 GOOSS scale and/or gastric bleeding) * Adhesions in abdominal cavity * Gastrooesophageal junction cancer or gastric cancer with spreading on oesophagus.
References
Publications (0)
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