Neoadjuvant Nivolumab for Operable Esophageal Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

Neoadjuvant Nivolumab for Operable Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03987815
• Other study ID #: 2019-01-147-0004
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: December 2019
• Source: Samsung Medical Center
• Contact: Jong-Mu Sun, Ph.D, MD
• Phone: 82-2-3410-3459
• Email: jongmu.sun[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single arm phase II study, in which maximum 3 cycles of nivolumab (240 mg fixed dose every 2 weeks) is administered for T2- or T3-node negative esophageal squamous cell carcinoma, before curative operation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed esophageal squamous cell carcinoma

2. Clinical stage T2N0 (invasion to muscularis propria) or T3N0 (invasion to adventitia)

3. ECOG performance 0 or 1

4. Age 19 years or older

Exclusion Criteria:

1. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Nivolumab
Nivolumab

Locations

Country	Name	City	State
Korea, Republic of	Jong-Mu Sun	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major pathologic response	Viable tumor comprised = 10% of resected tumor specimens	2 months
Secondary	Objective response rate (ORR)	Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions	2 months
Secondary	Positron Emission Tomography (PET)-CT response	Complete metabolic response is defined as the SUV of 2.5 or less than 2.5 of primary tumor	2 months
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