Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer
NCT03776487 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2026-04-15
Summary
This pilot phase I/II trial studies the side effects and how well nivolumab and ipilimumab in combination with chemotherapy and radiation therapy work in treating patients with gastric cancer that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Intensity-modulated radiation therapy uses thin beams of radiation of different strengths aimed at the tumor from many angles. This type of radiation therapy may reduce the damage to healthy tissue near the tumor. Giving nivolumab, ipilimumab, chemotherapy and radiation therapy may work better in treating patients with gastric cancer.
Conditions
- Clinical Stage 0 Gastric Cancer AJCC v8
- Clinical Stage 0 Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage I Gastric Cancer AJCC v8
- Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IIB Gastric Cancer AJCC v8
- Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IVA Gastric Cancer AJCC v8
- Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Gastric Adenocarcinoma
- Localized Gastric Carcinoma
- Localized Gastroesophageal Junction Adenocarcinoma
- Pathologic Stage 0 Gastric Cancer AJCC v8
- Pathologic Stage 0 Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage I Gastric Cancer AJCC v8
- Pathologic Stage IA Gastric Cancer AJCC v8
- Pathologic Stage IA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IB Gastric Cancer AJCC v8
- Pathologic Stage IB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIA Gastric Cancer AJCC v8
- Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIB Gastric Cancer AJCC v8
- Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIIA Gastric Cancer AJCC v8
- Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
Interventions
- DRUG
-
Given IV
- RADIATION
-
Intensity-Modulated Radiation Therapy
Undergo IMRT
- BIOLOGICAL
-
Given IV
- BIOLOGICAL
-
Given IV
- DRUG
-
Given IV
- PROCEDURE
-
Therapeutic Conventional Surgery
Undergo partial or total gastrectomy and lymphadenectomy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Mariela Blum · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-01-07
- Primary Completion
- 2026-12-30
- Completion
- 2026-12-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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