Status:
COMPLETED
Neoadjuvant Pembrolizumab Plus Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a study to evaluate the efficacy and safety of neoadjuvant pembrolizumab plus chemotherapy in resectable locally advanced esophageal squamous cell carcinoma patients
Detailed Description
The primary objective of the study is to assess the tumor response (by irRECIST) and pathological response of neoadjuvant pembrolizumab plus chemotherapy (carboplatin, paclitaxel). Secondary objectiv...
Eligibility Criteria
Inclusion
- Histologically proven squamous cell carcinoma of the esophagus.
- Surgical resectable (T3 or T4b, N0 or N+, M0), as determined by Endoscopic Ultra Sound (EUS),Positron Emission Tomography/Computed Tomography (PET/CT), Esophageal MRI and enhanced CT scan of neck, thorax and abdomen.
- Tumor length longitudinal ≤ 10 cm; if larger than 10 cm, inclusion should be discussed with the principal investigator.
- 18≤Age.
- Tumor does not involve gastro-esophageal junction.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematological, renal and hepatic functions defined as:
- neutrophiles ≥ 1.5 x 109/L platelets ≥ 100 x 109/L alanine transaminase≤2 x upper normal limit hemoglobin ≥ 5.6 mmol total bilirubin ≤ 1.5 x upper normal limit creatinine clearance (Cockcroft) ≥60 ml/min
- Written, voluntary informed consent
Exclusion
- Past or current history of malignancy other than entry diagnosis interfering with prognosis of esophageal cancer.
- T1, T2 tumors or in situ carcinoma.
- metastatic oesophageal cancer.
- Pregnancy (positive serum pregnancy test), planning to become pregnant, and lactation.
- Previous chemotherapy, radiotherapy, and/or treatment with checkpoint inhibitors.
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) precluding major surgery.
- Pulmonary fibrosis and/or severely impaired lung function precluding major surgery.
- Pre-existing motor or sensory neurotoxicity greater than World Health Organization (WHO) grade 1.
- Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\>10 mg/day prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
- Serious underlying medical condition which would impair the ability of the patient to receive the planned treatment, including prior allergic reactions to drugs containing Cremophor, such as teniposide or cyclosporine.
- Has an active infection requiring systemic therapy which has not resolved 3 days (simple infection such as cystitis) to 7 days (severe infection such as pyelonephritis) prior to the first dose of trial treatment.
- Has a diagnosis of acute or chronic hepatitis B, hepatitis C, known immunodeficiency or human immunodeficiency virus (HIV).
- Patients with prior allogeneic stem cell or solid organ transplantation.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05302011
Start Date
June 1 2020
End Date
June 30 2023
Last Update
October 10 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730