Neoadjuvant Chemotherapy Clinical Trial
— KEYSTONE-003Official title:
Efficacy and Safety of Pembrolizumab Plus Neoadjuvant Chemotherapy With Cisplatin and 5-Fluorouracill Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of Esophagogastric Junction
The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) followed Surgery for locally advanced adenocarcinoma of esophagogastric junction
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 31, 2024 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Histologically confirmed AEG, Siewert type I or II; 2. Potentially resectable cT3-4a, any N, M0 (AJCC 8 TNM classification); 3. Have a performance status of 0 or 1 on the ECOG Performance Scale; 4. Age 18-75 years old, both men and women; 5. Be willing and able to provide written informed consent/assent for the trial; 6. Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation; 7. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; 8. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor. Exclusion Criteria: 1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for AEG; 2. Ineligibility or contraindication for esophagectomy; 3. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; 4. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); 5. Has severe hypersensitivity and adverse events (=Grade 3) to nivolumab and/or any PD-1/PD-L1 inhibitors. |
Country | Name | City | State |
---|---|---|---|
China | Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Tianjin Medical University Cancer Institute and Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Major pathologic response (MPR) | Viable tumor comprised = 10% of resected tumor specimens | one month after surgery | |
Secondary | Progression-free survival (PFS) | Time from the enrollment to disease relapse after complete resection or death from any cause | 24 months | |
Secondary | Overall survival (OS) | Time from the enrollment to death of any cause | 24 months | |
Secondary | Pathologic complete response (pCR) | No tumor residue of resected tumor specimens | one month after surgery |
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