Adjuvant Pembrolizumab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma at H… (NCT03322267) | Clinical Trial Compass
CompletedPhase 2
Adjuvant Pembrolizumab for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma at High Risk of Recurrence
Taiwan26 participantsStarted 2018-10-27
Plain-language summary
In this study, participants with histologically diagnosed locally advanced esophageal squamous cell carcinoma who have received preoperative cisplatin-based chemoradiotherapy followed by surgery harbouring high risk of tumor recurrence will receive adjuvant cisplatin-based chemoradiotherapy followed by pembrolizumab. The primary study hypothesis is that adjuvant pembrolizumab will improve the 1-year recurrence-free survival rate compared to historical control.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Be willing and able to provide written informed consent/assent for the trial.
✓. Be ≥ 20 years of age on day of signing informed consent.
✓. Be a diagnosed by pathology or cytology with a locally advanced ESCC, which is clinically stage according to the TNM system of the American Joint Committee on Cancer (AJCC) Cancer Staging System (7th edition), fulfilling one of the following criteria as determined by endoscopic ultrasound, computed tomography, bronchoscopy and positron emission tomography:
✓. T3, N0, M0;
✓. T4a, N0, M0;
✓. T1-4a, N1-3, M0.
✓. Have been treated with preoperative cisplatin-based CRT followed by esophagectomy with lymph node dissection for the locally advanced ESCC (defined by above criteria).
✓. Have a performance status of 0 or 1 on the ECOG Performance Scale.
Exclusion criteria
✕. Is diagnosed with adenocarcinoma of esophagus or gastroesophageal junction.
✕. Has synchronously diagnosed with a squamous cell carcinoma of aero-digestive way, other than esophageal cancer.
✕. Has prior malignancy, except for: (a) adequately treated basal cell or squamous cell skin cancer; (b) in-situ cervical cancer; (c) previously diagnosed malignancy which have been adequately treated and shown no evidence of recurrence for more than 5 years.
✕. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
✕. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
✕. Has a known history of active TB (Bacillus Tuberculosis)
✕. Hypersensitivity to pembrolizumab or any of its excipients.
✕. Has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.