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

NCT ID: NCT04863079

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-04-30

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.

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.

Conditions

ESCC; Adjuvant Treatment; Lymph Node Positive; Pembrolizumab

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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+.

Group Type: EXPERIMENTAL

Pembrolizumab Injection [Keytruda]

Intervention Type: DRUG

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

Interventions

Pembrolizumab Injection [Keytruda]

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed ESCC;

2. Patients have not received neoadjuvant therapy.

3. Thoracic ESCC with R0 resection and positive postoperative lymph nodes;

4. Have a performance status of 0 or 1 on the ECOG Performance Scale;

5. Age 18-70 years old, both men and women;

6. Be willing and able to provide written informed consent/assent for the trial;

7. Demonstrate adequate organ function , all screening labs should be performed within 10 days of treatment initiation;

8. 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;

9. Be willing to provide postoperative tissue specimens. After tumor recurrence, continue to be willing to provide tissue samples such as needle biopsy.

Exclusion Criteria

1. Neoadjuvant therapy (radiotherapy, immunotherapy, or chemotherapy) for ESCC;

2. Non-R0 resection for ESCC;

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 pembrolizumab and/or any PD-1/PD-L1 inhibitors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dingzhi Huang, MD, PhD

Role: STUDY_DIRECTOR

Tianjin Medical University Cancer Institute and Hospital

Locations

Tianjin Medical University Cancer Institute and Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongjing Jiang, MD, PhD

Role: CONTACT

jianghongjing@tmu.edu.cn

+8618622221069

Chuangui Chen, MD, PhD

Role: CONTACT

ccg209@163.com

+8618622228653

Facility Contacts

Hongjing Jiang, MD, PhD

Role: primary

jianghongjing@tmu.edu.cn

+8618622221069

Chuangui Chen, MD, PhD

Role: backup

ccg209@163.com

+8618622228653

Other Identifiers

E20210220A

Identifier Type: -

Identifier Source: org_study_id