Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localized Esophageal and Gastroesophageal Adenocarcinoma
NCT03784326 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43
Last updated 2026-05-05
Summary
To learn if atezolizumab in combination with oxaliplatin and 5-fluorouracil (5-FU), when given before surgery, can help to control esophageal and/or gastroesophageal cancer. To learn if adding tiragolumab to the above drug combination can help to control the disease.
Conditions
- Clinical Stage II Esophageal Adenocarcinoma AJCC v8
- Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
- Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
- Clinical Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage III Esophageal Adenocarcinoma AJCC v8
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IC Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
- Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
- Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
Interventions
- DRUG
-
Given IV (vein)
- PROCEDURE
-
Conventional Surgery
Undergo surgical resection
- DRUG
-
Given IV (vein)
- DRUG
-
Given IV (vein)
- DRUG
-
Tiragolumab
Given IV (vein)
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
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-02-19
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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