๐๏ธ Verified NIH Record โข Updated 2026-07-24
Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localized Esophageal and Gastroesophageal Adenocarcinoma (NCT03784326)
๐ต Active, Not Recruiting Phase2 ๐ Investigational Drug / Biologic Sponsor: M.D. Anderson Cancer Center
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (25 items) and avoid the listed exclusions (38 items).
Location: M D Anderson Cancer Center โ Houston, Texas
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria (cohort 1 and cohort 2)
- Patients with T1aN0, T4b, or metastatic cancer will be excluded.
- Squamous cell carcinoma histology
- Invasion into nearby organs (T4b) with or increased risk for fistula
- Significant comorbid conditions (defined as uncontrolled diabetes, active angina or heart failure, uncontrolled hypertension (\>160 mmHg systolic or โฅ100 mmHg diastolic) or increased risk of prolonged QTc (QTc \> 500 ms), or active psychiatric condition that prevents consistent participation and compliance).
- More than grade 1 neuropathy.
- Unable to comprehend the requirements of the study or comply with it.
- Active bleeding from primary tumor requiring radiation therapy.
- History of leptomeningeal disease
- Uncontrolled tumor-related pain Patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions (e.g., bone metastases or metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patients should be recovered from the effects of radiation. There is no required minimum recovery period. Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) Patients with indwelling catheters (e.g., PleurX) are allowed.
- Uncontrolled or symptomatic hypercalcemia (\> 1.5 mmol/L ionized calcium or calcium \> 12 mg/dL or corrected serum calcium \> ULN)
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- M D Anderson Cancer Center โ Houston, Texas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.