Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squmous Cell Carcinoma of Esophageus

• Status: Active, not recruiting
• Trial end date: 2020-06-17
• Target enrollment: 0
• Participant gender: All

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. And this study will provide valuable information for further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer treatment.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hecheng Li M.D., Ph.D
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:

1. Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell carcinoma

2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

3. Patients approve and sign the informed consent

Exclusion Criteria:

• 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