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New treatment option for Esophageal Adenocarcinoma
Official title Oxaliplatin and Liposomal Irinotecan (Plus Trastuzumab for HER2-positive Disease) in Advanced Esophageal and Gastric Adenocarcinoma
ClinicalTrials.gov ID: NCT04150640
What this study is testing
What is Nal-IRI?
Nal-IRI is an investigational medicine, being studied as a potential treatment for esophageal adenocarcinoma.
Also referred to as liposomal irinotecan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open label, phase II, multi-site trial evaluating the efficacy and safety of the combination of 5-FU, oxaliplatin, nal-IRI, and immunotherapy (plus trastuzumab for HER2-positive tumors) as first-line therapy for participants with advanced Esophageal and Gastric Adenocarcinoma (EGA). The investigators hypothesize that this drug combination will be better tolerated than current first-line chemotherapy combinations for this disease.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the...
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Histological or cytological confirmed locally advanced or metastatic EGA. Known HER2 status prior to treatment initiation required. Known PDL1 CPS...
- Measurable disease according to RECIST v1.1.
- No prior lines of systemic therapy for advanced disease.
You likely can't join if
- Known hypersensitivity to 5-FU, oxaliplatin or other platinum agents, or any of the components of nal-IRI and other liposomal products.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required prior to enrollment).
- Other active malignancy requiring treatment within the last 2 years. Exceptions include people with non-melanoma skin cancer, non-invasive/in situ...
- Current therapy with other investigational agents or participation in another clinical study (supportive care and nontherapeutic trial participation...
- Major surgery within 28 days or minor surgery within 14 days of the start of the study treatment, except for tumor biopsy or placement of central...
- Radiotherapy less than 7 days prior to the start of the study treatment
See the full eligibility criteria
Who can join
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.
- Histological or cytological confirmed locally advanced or metastatic EGA. Known HER2 status prior to treatment initiation required. Known PDL1 CPS status prior to treatment initiation.
- Measurable disease according to RECIST v1.1.
- No prior lines of systemic therapy for advanced disease.
- Participants who had received neoadjuvant or adjuvant therapy or definitive chemoradiation will be allowed to participate if recurrence occurred 6 months or longer from the completion of all prior treatments.
- Demonstrate adequate organ function as defined below; all screening labs to be obtained within 14 days prior to registration
- Absolute Neutrophil Count (ANC) ≥1,500 /μl without the use of hematopoietic growth factors
- Hemoglobin (Hgb) ≥8 g/dL (blood transfusions are permitted for participants with hemoglobin levels below 8 g/dL)
- Platelets ≥100,000 /μl
- Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl). CrCl calculation using the Cockcroft-Gault formula. ≥50 mL/min...
- Bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction); abnormal bilirubin (≤1 5 × upper limit of normal (ULN)) is allowed for patients with Gilbert's disease
- Aspartate aminotransferase (AST) ≤ 2.5 X ULN OR ≤ 5 X ULN for people with liver metastases
- Alanine aminotransferase (ALT) ≤ 2.5 X ULN OR ≤ 5 X ULN for people with liver metastases
- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
- Women of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. NOTE: Women are considered of child bearing potential unless they are surgically sterile (have...
- Women of childbearing potential and males must be willing to abstain from heterosexual activity or to use a form of effective method of contraception from the time of informed consent until 30 days after treatment...
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
What rules you out
- Known hypersensitivity to 5-FU, oxaliplatin or other platinum agents, or any of the components of nal-IRI and other liposomal products.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency (testing not required prior to enrollment).
- Other active malignancy requiring treatment within the last 2 years. Exceptions include people with non-melanoma skin cancer, non-invasive/in situ cancer or low-risk prostate cancer requiring hormonal therapy only.
- Current therapy with other investigational agents or participation in another clinical study (supportive care and nontherapeutic trial participation allowed if not receiving an investigational drug). Participants may...
- Major surgery within 28 days or minor surgery within 14 days of the start of the study treatment, except for tumor biopsy or placement of central infusion device (port placement).
- Radiotherapy less than 7 days prior to the start of the study treatment
- Participants who receive nivolumab or pembrolizumab in addition to chemotherapy should not have any contraindications to immune checkpoint inhibitors and should not have received immunotherapy agents for the treatment...
- Participants must not have active autoimmune disease that has required systemic treatment in the past 2 years. Participants are permitted to receive immunotherapy l if they have vitiligo, type I diabetes mellitus...
- Participants must not have a condition requiring systemic treatment with either corticosteroids (\>10 mg/day prednisone equivalents) or other immunosuppressive medications within 14 days of study immunotherapy...
- Psychological, familial, or sociological condition potentially hampering compliance with the study protocol and follow-up schedule.
- Active infection requiring systemic therapy.
- Pregnant or breastfeeding.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by...
- Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) less than 6 months before inclusion.
- NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure.
- Known history of Human Immunodeficiency Virus (HIV).
The study team makes the final eligibility decision.
Where it's taking place
- Madison, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madison, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.