Status:
COMPLETED
Pre-Operative Pembrolizumab + Chemoradiation in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Fujian Medical University Union Hospital
Zhejiang University
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To investigate the safety and activity of preoperative pembrolizumab combined with chemoradiotherapy for resectable esophageal squamous cell carcinoma (ESCC) ,20 patients enrolled in Phase Ib PALACE-1...
Detailed Description
For locally advanced esophageal squamous cell carcinoma (ESCC), neoadjuvant chemoradiotherapy followed by surgery has been recommended as the optimal therapeutic strategy.Patients who achieved patholo...
Eligibility Criteria
Inclusion
- A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
- Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients approve and sign the informed consent
Exclusion
- Patients with active autoimmune disease or history of autoimmune disease.
- Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications.
- Subjects with a history of symptomatic interstitial lung disease.
- History of allergy to study drug components.
- Women must not be pregnant or breast-feeding.
- Men with female partners (WOCBP) that are not willing to use contraception.
- Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy.
- Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT04435197
Start Date
August 11 2020
End Date
June 30 2024
Last Update
July 3 2024
Active Locations (2)
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1
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
2
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025