NCT03917966

The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy or Apatinib for Locally Advanced ESCC

The Phase II Trial of SHR-1210 Combined With Preoperative Chemotherapy or Apatinib for Locally Advanced Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma

Detailed description

In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. Investigator designed a single-arm, open-label, phase II trial of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 combined with preoperative chemotherapy or Apatinib for locally advanced esophageal squamous cell carcinoma.

Conditions

• Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	SHR-1210+docetaxel+nedaplatin	neoadjuvant chemotherapy:SHR-1210, 200mg,q2w, a total of 3 times; docetaxel 75mg/m2 ivgtt d1, nedaplatin 75mg/m2 ivgtt d1, q3w, for 2 cycles.The patient was evaluated after 2 cycles of neoadjuvant chemotherapy. The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.
DRUG	SHR-1210+Apatinib	SHR-1210, 200 mg, q2w; Apatinib, 250mg, qd; 4 weeks is a cycle, a total of 2 cycles

Timeline

• Start date: 2020-04-07
• Primary completion: 2023-10-07
• Completion: 2024-10-07
• First posted: 2019-04-17
• Last updated: 2022-03-04

Locations

1 site across 1 country: China