Status:
COMPLETED
Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus
Lead Sponsor:
Hecheng Li M.D., Ph.D
Conditions:
Esophageal Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell carcinoma. An...
Detailed Description
Esophageal cancer ranks the eighth most common cancer (the fifth most common cancer in China), while ESCC is the most common subtype in Asia (more than 90 % in china). Radical resection is thought to ...
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
- 1\. Patients with active autoimmune disease or history of autoimmune disease 2. Patients who have a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications 3. Subjects with a history of symptomatic interstitial lung disease 4. History of allergy to study drug components 5. Women must not be pregnant or breast-feeding 6. Men with female partners (WOCBP) that are not willing to use contraception 7. Patient has received prior chemotherapy, radiotherapy, target therapy and immune therapy for this malignancy or for any other past malignancy 8. 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 :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03792347
Start Date
January 21 2019
End Date
June 17 2020
Last Update
November 22 2023
Active Locations (1)
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1
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025