Trials / Active Not Recruiting
Active Not RecruitingNCT03784326
Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localized Esophageal and Gastroesophageal Adenocarcinoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Primary Objectives: * Atezolizumab +/- tiragolumab in combination with oxaliplatin and 5-fluorouracil (modified FOLFOX) therapy in the neoadjuvant setting will achieve a pathological complete response of approximately 20% in patients with localized esophageal and gastroesophageal (GEJ) adenocarcinoma. Secondary Objectives: * To evaluate safety and toxicity profile of intravenous Atezolizumab +/- Tiragolumab in combination with Oxaliplatin and 5-FU chemotherapy as neoadjuvant treatment for resectable esophageal or GEJ adenocarcinoma. * To assess the efficacy of the combination by tumor regression grade scoring in the surgical specimen. * To assess the overall safety and tolerability of adjuvant Atezolizumab +/- Tiragolumab in subjects with resected esophageal and GEJ cancer * To evaluate disease free survival (DFS) and overall survival (OS) in cohort 1 and cohort 2 * To explore changes in tumor stroma profile before and after immunotherapy in combination with chemotherapy
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
| Type | Name | Description |
|---|---|---|
| DRUG | Atezolizumab | Given IV (vein) |
| PROCEDURE | Conventional Surgery | Undergo surgical resection |
| DRUG | Fluorouracil | Given IV (vein) |
| DRUG | Oxaliplatin | Given IV (vein) |
| DRUG | Tiragolumab | Given IV (vein) |
Timeline
- Start date
- 2019-02-19
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2018-12-21
- Last updated
- 2026-02-03
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03784326. Inclusion in this directory is not an endorsement.