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
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 150
- Primary Endpoint
- Overall 2-year survival
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
neoadjuvant chemoimmunotherapy
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.
Intervention: neoadjuvant chemoimmunotherapy (Procedure)
neoadjuvant chemotherapy
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.
Outcomes
Primary Outcomes
Overall 2-year survival
Time Frame: 2 years
Overall 2-year survival for patients who received radical (R0) surgical treatment after downstaging (M1 -\> M0; Cyt "+" -\> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis.
Secondary Outcomes
- Mortality(24 months)
- Portability of the systemic therapy methods(6,9,12,24 months)
- Downstaging tumor(2 years)
- Quality of life(6, 12, 18, 24 months)
- Morbidity(30 days)