Gastric Cancer, Metastatic Clinical Trial
Official title:
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
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.
| Status | Not yet recruiting |
| Enrollment | 150 |
| Est. completion date | December 2020 |
| Est. primary completion date | November 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Moscow Clinical Scientific Center |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall 2-year survival | 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. | 2 years | No |
| Secondary | Portability of the systemic therapy methods | Portability of the systemic therapy methods (intraperitoneal immunotherapy and systemic chemotherapy). Toxicity scale. | 6,9,12,24 months | Yes |
| Secondary | Mortality | Mortality related to intraperitoneal immunotherapy and systemic chemotherapy It is defined as the death within 24 months from the start of the treatment regardless of the reason. | 24 months | Yes |
| Secondary | Downstaging tumor | Number of patients that were downstaged (M1 -> M0; Cyt "+" -> Cyt "-") with initial free cancer cells in the abdominal cavity without macroscopic canceromathosis. | 2 years | Yes |
| Secondary | Morbidity | Number of postoperative morbidity and mortality in the early post-operative period (for patients who received radical (R0) surgical treatment after downstaging) | 30 days | Yes |
| Secondary | Quality of life | Quality of life ECOG scale. | 6, 12, 18, 24 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
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