NCT04533490

A Phase Ⅱ Clinical Trial of Camrelizumab for Adjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma

A Multi-center, Single-arm, Open Phase Ⅱ Clinical Trial of Camrelizumab for Adjuvant Treatment of Resectable Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 for adjuvant treatment of resectable esophageal squamous cell carcinoma

Detailed description

Although esophagectomy is still the standard treatment for patients with localized esophageal cancer, the long-term therapeutic effect is not satisfactory.About 50% of patients experienced relapse in the first year after treatment. The 5-year survival rate of esophageal cancer patients treated by surgery is still less than 30%. Although the effect of preoperative treatment is relatively clear, the effect of postoperative treatment, especially postoperative chemotherapy, is still controversial and no consensus has been reached.The basic reason is that the postoperative trauma of esophageal cancer is large, and the patients' tolerance to chemotherapy is poor. The efficacy of immunocheckpoint inhibitors in metastatic ESCC has been recognized.We plan to conduct a phase II multicenter, single arm, open phase II clinical trial to evaluate the efficacy and safety of humanized anti PD-1 monoclonal antibody SHR-1210 in adjuvant treatment of resectable esophageal squamous cell carcinoma.

Conditions

• Resectable Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	SHR-1210	After the subjects were enrolled in the study, the patients were treated with SHR-1210 200mg igvtt q3w from 1 to 2 months after operation until disease progression or intolerable toxicity, and the longest medication period was no more than 12 months

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-10-01
• Completion: 2023-10-01
• First posted: 2020-08-31
• Last updated: 2021-08-23