The Safety and Feasibility of Neoadjuvant Adebrelimab With Dalpiciclib for the Treatment of Resectable Esophageal Squamous Cell Carcinoma：A Phase 1 Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to explore the safety and feasibility of anti-programmed cell death ligand 1(PD-L1) immunotherapy, Adebrelimab, combined with cyclin-dependent kinase 4/6 blockade, Dalpiciclib, as a new neoadjuvant treatment regimen for patients with resectable esophageal squamous cell carcinoma (ESCC).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Patients diagnosed with esophageal squamous cell cancer by gastroscopic biopsies.
‣ The primary tumor should be located in the thorax.
⁃ The patients should be evaluated to be able to have surgical resection before the surgery according to the examinations .
• The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.
• The patients should be able to understand our research and be willing to accept surgical treatment and sign the informed consent.
Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Jin Zhou, MD.,PhD.
zhoujin096@scu.edu.cn
+8613880626596
Backup
Shangwei Sun
sunshangwei@stu.scu.edu.cn
+8615291996883
Time Frame
Start Date:2023-12-29
Estimated Completion Date:2025-01-15
Participants
Target number of participants:6
Treatments
Experimental: Adebrelimab+Dalpiciclib(100mg)
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.~Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.~For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.
Experimental: Adebrelimab+Dalpiciclib(150mg)
Adebrelimab will be given at a dose of 20 mg per kilogram of body weight every three weeks on day 23 of a planned 28-day cycle, and two doses before surgery.~Dalpiciclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle and it will be given for two cycles.~For dalpiciclib, there is 2 dose levels, 100mg qd and 150 mg qd, and if no patients experience DLT on 100mg level, 150mg level will be administered.