Pembrolizumab in Post Radical Operation ESCC Patients With Lymph Node Positive ( KEYSTONE-004 )

Sponsor

Tianjin Medical University Cancer Institute and Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04863079

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of postoperative adjuvant treatment of pembrolizumab in patients with thoracic esophageal squamous cell carcinoma （ESCC） who have not received neoadjuvant therapy before undergoing R0 resection, and have positive postoperative lymph nodes.

Condition or Disease	Intervention/Treatment	Phase
ESCC Adjuvant Treatment Lymph Node Positive Pembrolizumab	Drug: Pembrolizumab Injection [Keytruda]	Phase 2

Detailed Description

For patients with thoracic esophageal squamous cell carcinoma （ESCC） who have undergone R0 resection, have not received neoadjuvant therapy, and have positive postoperative lymph nodes, there is no international consensus on whether postoperative adjuvant therapy is required. The JCOG9204 study reported that for patients with ESCC with positive lymph nodes after R0 resection, postoperative adjuvant chemotherapy can improve the disease-free survival (DFS) of the ESCC patients. However, due to the adverse effects of chemotherapy, patients are often difficult to tolerate. We designed a single-arm, open-label, phase II trial of pembrolizumab for adjuvant treatment after R0 resection of thoracic ESCC Patients with lymph node positive. The purpose of this study is to observe and evaluate the efficacy and safety.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

82 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pembrolizumab for Adjuvant Treatment After R0 Resection of Thoracic ESCC Patients With Lymph Node Positive: A Single-arm, Open-label, PhaseⅡTrial

Anticipated Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pembrolizumab for Postoperative Adjuvant Treatment of ESCC Participants receive pembrolizumab 200 mg IV, Q3W, up to one year or disease progression or intolerance as postoperative adjuvant treatment of ESCC with pN+.	Drug: Pembrolizumab Injection [Keytruda] Pembrolizumab 200 mg IV, Q3W, up to one year or disease progression or intolerance.

Arm

Intervention/Treatment

Experimental: Pembrolizumab for Postoperative Adjuvant Treatment of ESCC

Participants receive pembrolizumab 200 mg IV, Q3W, up to one year or disease progression or intolerance as postoperative adjuvant treatment of ESCC with pN+.

Drug: Pembrolizumab Injection [Keytruda]

Pembrolizumab 200 mg IV, Q3W, up to one year or disease progression or intolerance.

Outcome Measures

Primary Outcome Measures

Overall survival (OS) [24 months]
Time from the enrollment to death of any cause
Disease-free survival (DFS) [24 months]
Time from the enrollment to disease relapse after complete resection or death from any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed ESCC;
Patients have not received neoadjuvant therapy.
Thoracic ESCC with R0 resection and positive postoperative lymph nodes;
Have a performance status of 0 or 1 on the ECOG Performance Scale;
Age 18-70 years old, both men and women;
Be willing and able to provide written informed consent/assent for the trial;
Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation;
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;
Be willing to provide postoperative tissue specimens. After tumor recurrence, continue to be willing to provide tissue samples such as needle biopsy.

Exclusion Criteria:

Neoadjuvant therapy (radiotherapy, immunotherapy, or chemotherapy) for ESCC;
Non-R0 resection for ESCC;
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;
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);
Has severe hypersensitivity and adverse events (≥Grade 3) to pembrolizumab and/or any PD-1/PD-L1 inhibitors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Medical University Cancer Institute and Hospital	Tianjin		China	300060

Sponsors and Collaborators

Tianjin Medical University Cancer Institute and Hospital

Investigators

Study Director: Dingzhi Huang, MD, PhD, Tianjin Medical University Cancer Institute and Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tianjin Medical University Cancer Institute and Hospital

ClinicalTrials.gov Identifier:

NCT04863079

Other Study ID Numbers:

E20210220A

First Posted:

Apr 28, 2021

Last Update Posted:

Apr 28, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Pembrolizumab

Study Results

No Results Posted as of Apr 28, 2021