The Safety and Feasibility of Neoadjuvant Camrelizumab With Palbociclib 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 1(PD-1) immunotherapy, Camrelizumab, combined with cyclin-dependent kinase 4/6 blockade, Palbociclib, 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 and evaluated resectable( cT1b-T3N1-3M0, cT3N0M0) by CT/MRI/EUS

• The patients should be at the range of 18-75 years old, Eastern Cooperative Oncology Group (ECOG) 0-1.

• The patients should have no functional disorders in major organs. Blood routine tests, as well as lung, liver, kidney, and heart functions should be basically normal.

• 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
zhoujin096@scu.edu.cn
13880626596
Time Frame
Start Date: 2024-08-04
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 6
Treatments
Experimental: Camrelizumab+Palbociclib(100mg) 3 patients
For palbociclib, there is 2 dose levels, 100mg qd and 125 mg qd, and if no patients experience DLT on 100mg level, 125mg level will be administered.
Experimental: Camrelizumab+Palbociclib(125mg) 3 patients
For palbociclib, there is 2 dose levels, 100mg qd and 125 mg qd, and if no patients experience DLT on 100mg level, 125mg level will be administered.
Related Therapeutic Areas
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov