Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localize… (NCT03784326) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase I/II Study of Perioperative Chemotherapy Plus Immunotherapy Followed by Surgery in Localized Esophageal and Gastroesophageal Adenocarcinoma
United States43 participantsStarted 2019-02-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (cohort 1 and cohort 2)
* Signed Informed Consent Form
* Age ≥ 18 years at time of signing Informed Consent Form
* Ability to comply with the study protocol, in the investigator's judgment
* Histologically or cytologically confirmed esophageal or gastroesophageal type I or II adenocarcinoma
* No prior therapy including chemotherapy or radiation therapy.
* Patients with T1N1, and T2-3 with any N will be eligible.
* ECOG Performance Status of 0-1
* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
* ANC ≥ 1.5 x 109/L (1500/L) without granulocyte colony-stimulating factor support
* Lymphocyte count ≥ 0.5 x 109/L (500/L)
* Platelet count ≥ 100 x 109/L (100,000/L) without transfusion
* Hemoglobin ≥ 90 g/L (9 g/dL) Patients may be transfused to meet this criterion.
* AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN)
* Serum bilirubin ≤ 1.5 x ULN with the following exception:
Patients with known Gilbert disease: serum bilirubin level ≤ 3 x ULN
* Serum creatinine ≤ 1.5 x ULN \[or\] Creatinine clearance ≥ 70 mL/min (calculated using the Cockcroft-Gault formula)}
* Serum albumin ≥ 25 g/L (2.5 g/dL)
* For patients not receiving therapeutic anticoagulation: INR and aPTT ≤ 1.5 x ULN
* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
* Medically fit for surgery based on surgeon's asses…