Actively Recruiting
Pembrolizumab Plus Chemo in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma (Eastern Cooperative Thoracic Oncology Projects 2004, ECTOP-2004)
Led by Fudan University · Updated on 2023-07-13
128
Participants Needed
2
Research Sites
184 weeks
Total Duration
On this page
Sponsors
F
Fudan University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this trial is to evaluate efficacy and safety of pembrolizumab plus standard of care (SOC) chemotherapy with cisplatin and paclitaxel as neoadjuvant treatment in participants with locally advanced esophageal squamous cell carcinoma (ESCC), and to explore treatment resistance mechanisms.
CONDITIONS
Official Title
Pembrolizumab Plus Chemo in Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma (Eastern Cooperative Thoracic Oncology Projects 2004, ECTOP-2004)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 75 years with confirmed locally advanced and surgically resectable esophageal squamous cell carcinoma (cT2-T4a NX M0).
- Participants must be previously untreated for this cancer.
- Male participants must agree to use contraception during treatment and for at least 95 days after last dose.
- Female participants must not be pregnant or breastfeeding and either not of childbearing potential or agree to contraception during treatment and for 120 days after last dose.
- Participants must provide written informed consent.
- Participants must have measurable disease based on RECIST 1.1 criteria.
- Participants must provide archival tumor tissue or a new biopsy sample.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Participants must have adequate organ function based on tests within 10 days before treatment start.
You will not qualify if you...
- Women of childbearing potential with a positive pregnancy test within 72 hours prior to enrollment.
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune checkpoint agents.
- Prior systemic anti-cancer therapy or investigational agents within 4 weeks before enrollment.
- Prior radiotherapy within 2 weeks before starting study treatment unless recovered from toxicities.
- Receipt of live or live-attenuated vaccines within 30 days before the first study drug dose.
- Participation in other investigational drug or device studies within 4 weeks before first dose.
- Immunodeficiency or use of systemic steroids over 10 mg prednisone daily or other immunosuppressive therapy within 7 days before first dose.
- Active additional malignancy requiring treatment or progressing within past 2 years (some skin or in situ cancers allowed).
- Known active brain metastases or carcinomatous meningitis unless stable and off steroids for at least 14 days.
- Severe hypersensitivity (grade 3 or higher) to pembrolizumab or its components.
- Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy allowed).
- History or presence of pneumonitis or interstitial lung disease requiring steroids.
- Active infection needing systemic therapy.
- Known HIV infection.
- Known active Hepatitis B or C infection.
- Conditions, therapies, or abnormalities that could interfere with study participation or results.
- Psychiatric or substance abuse disorders interfering with trial cooperation.
- Pregnant, breastfeeding, or planning pregnancy during study and 120 days after last dose.
- History of allogenic tissue or solid organ transplant.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Fudan University Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
H
Haiquan Chen, M.D., Ph.D.
CONTACT
B
Bin Li, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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