NCT05738434

Camrelizumab in Combination With Apatinib Mesylate Plus Short-course Chemotherapy for Advanced ESCC

A Randomized, Controlled, Multicenter Clinical Study of Camrelizumab in Combination With Apatinib Mesylate and Chemotherapy Versus Camrelizumab Plus Chemotherapy in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of patients with advanced esophageal squamous cell carcinoma treated with camrelizumab combined with Apatinib mesylate plus short-course chemotherapy versus standard chemotherapy in first line

Conditions

• Esophageal Cancer by AJCC V8 Stage

Interventions

Type	Name	Description
DRUG	Camrelizumab+Apatinib+Chemotherapy→Camrelizumab+Apatinib	camrelizumab 200 mg, i.v. d1,q3w; apatinib 250 mg, p.o. qd,q3w; cisplatin 25 mg/m2, i.v. d1-d3,q3w; According to investigator' choice： paclitaxel 135\~150 mg/m2, i.v. d1,q3w; paclitaxel-albumin 150\~180 mg/m2, i.v. d1,q3w. up to 4 cycles and sequential maintenance therapy： camrelizumab 200 mg, i.v. d1,q3w; apatinib 250 mg, p.o. qd,q3w
DRUG	Camrelizumab+Chemotherapy→Camrelizumab	camrelizumab 200 mg, i.v. d1,q3w; cisplatin 25 mg/m2, i.v. d1-d3,q3w; According to investgator' choice： paclitaxel 175 mg/m2, i.v. d1,q3w; paclitaxel-albumin 200 mg/m2, i.v. d1,q3w up to 6 cycles and sequential maintenance therapy： camrelizumab 200 mg, i.v. d1,q3w;

Timeline

• Start date: 2023-03-02
• Primary completion: 2025-09-01
• Completion: 2027-03-01
• First posted: 2023-02-22
• Last updated: 2024-11-21

Locations

1 site across 1 country: China