NCT03985670

Teripalimab Plus Chemotherapy in Local Advanced Esophageal Cancer

Neoadjuvant Teripalimab Plus Chemotherapy in Local Advanced Esophageal Squamous Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The prognosis of locally advanced esophageal squamous cell carcinoma is poor,the role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer.PD-1 antibody has been shown to improve the pathological complete response rate in NSCLC, however, the data in neoadjuvant of esophageal squamous carcinoma is relatively rare. This study was designed to know the value of PD-1 antibody in neoadjuvant therapy of esophageal cancer.

Detailed description

The prognosis of locally advanced esophageal squamous cell carcinoma is poor, the 5-year survival rate is less than 50%. It is necessary to conduct studies in these patients to reduce the rate of postoperative recurrence and prolong the disease-free survival. The role of chemotherapy as neoadjuvant therapy in locally advanced esophageal cancer has been established, which can convert some unresectable esophageal cancer into resectable esophageal cancer. The PD-1 antibody, teripalimab, is an immunological checkpoint inhibitor that has shown clinical efficacy in advanced esophageal cancer, but there has been relatively few data on neoadjuvant therapy. This study was designed to comprehend the pathological complete response rate, disease-free survival, and safety of neoadjuvant therapy with chemotherapy plus teriprilin patients with locally advanced esophageal squamous cell carcinoma.

Conditions

• Squamous Cell Carcinoma
• Esophageal Cancer
• Perioperative Period

Interventions

Type	Name	Description
DRUG	teripalimab plus chemotherapy	teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1
DRUG	chemotherapy plus teripalimab	paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3

Timeline

• Start date: 2019-07-10
• Primary completion: 2021-04-30
• Completion: 2023-04-30
• First posted: 2019-06-14
• Last updated: 2019-12-12

Locations

1 site across 1 country: China