Pembrolizumab Plus Neoadjuvant Chemotherapy for Locally Advanced EGJ Adenocarcinoma

NCT04813523 | Unknown Phase 2 FDA Drug

• 1 other identifier: TianjinCIH20210169
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Adenocarcinoma of Esophagogastric Junction; Neoadjuvant Chemotherapy; Pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Major pathologic response (MPR)

  Viable tumor comprised ≤ 10% of resected tumor specimens

  one month after surgery

Secondary Outcomes (3)

• Progression-free survival (PFS)

  24 months

• Overall survival (OS)

  24 months

• Pathologic complete response (pCR)

  one month after surgery

Study Arms (1)

Experimental: Pembrolizumab+Cisplatin+5-FU

EXPERIMENTAL

Participants receive preoperative pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W), cisplatin 80 mg/m\^2 IV Q3W, and 5-FU 600 mg/m\^2/day IV infusion on Days 1 to 5. There are 3 cycels of preoprative therapy and 3 cycles of postoperative therapy.

Drug: Pembrolizumab Injection [Keytruda]

Interventions

Pembrolizumab Injection [Keytruda] DRUG

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.

Also known as: Cisplatin, 5-FU

Experimental: Pembrolizumab+Cisplatin+5-FU

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed AEG, Siewert type I or II;
• Potentially resectable cT3-4a, any N, M0 (AJCC 8 TNM classification);
• Have a performance status of 0 or 1 on the ECOG Performance Scale;
• Age 18-75 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 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.

You may not qualify if:

• Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for AEG;
• Ineligibility or contraindication for esophagectomy;
• 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 nivolumab and/or any PD-1/PD-L1 inhibitors.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Interventions

pembrolizumab; Cisplatin; Fluorouracil

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hongjing Jiang, MD, PhD

CONTACT

8618622221069; jianghongjing@tmu.edu.cn

Xiaofeng Duan, MD, PhD

CONTACT

8613752437179; xduan@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: April 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2024
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

CN (1)