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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04813523
Other study ID # TianjinCIH20210169
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 1, 2021
Est. completion date March 31, 2024

Study information

Verified date March 2021
Source Tianjin Medical University Cancer Institute and Hospital
Contact Hongjing Jiang, MD, PhD
Phone 8618622221069
Email jianghongjing@tmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The neoadjuvant chemotherapy/chemoradiotherapy with surgery is the standard treatment in NCCN guideline. But many patients refused or abandon radiotherapy because of the intolerable adverse effects. We designed a single-arm, open-label, phase II trial of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) followed by radical surgery for locally advanced adenocarcinoma of esophagogastric junction. The purpose of this study is to observe and evaluate the efficacy and safety.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Pembrolizumab Injection [Keytruda]
Neoadjuvant period: pembrolizumab 200mg IV, Q3W with three cycles. Adjuvant period: pembrolizumab 200 mg IV, Q3W, up to one year, which should be performed within 3-6 weeks after surgery.

Locations

Country Name City State
China Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

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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