Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Esophageal squamous cell cancer (ESCC) has a high incidence in China. Although the fast development of immune check point inhibitors (ICIs), the rate of pCR is limited with the mode of ICIs combined with neoadjuvant radiochemotherapy. The rate of pCR under ICIs combined with neoadjuvant radiochemotherapy was reported around 50%, which means more than half of those patients could not obtain pCR in reality. In order to explore a more effective mode of neoadjuvant therapy for ESCC, we designed this study to evaluate the effect of PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy in local advanced ESCC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• diagnosed with esophageal squamous cell cancer;

• staged with cT1N+M0/cT2-3N0-3M0;

• experienced no cancer-related treatment;

• ECOG 0-1;

• Expected survival more than 6 months;

• aimed at neoadjuvant therapy for surger;

• have adquate organ function.

Locations
Other Locations
China
the First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Fuwei Wang
wanxbo@zzu.edu.cn
0086-037166278517
Backup
Xiangbo Wan
wanxbo@zzu.edu.cn
0086-037166271152
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 208
Treatments
Experimental: Arm 1: cadonilizumab combined with neoadjuvant radiochemotherapy
Subjects randomized in Arm 1 will be treated with cadonilizumab plus neoadjuvant radiochemotherapy before surgery.
Placebo_comparator: Arm 2: neoadjuvant radiochemotherapy
Subjects randomized in Arm 2 will be treated with neoadjuvant radiochemotherapy before surgery.
Related Therapeutic Areas
Sponsors
Leads: The First Affiliated Hospital of Zhengzhou University

This content was sourced from clinicaltrials.gov

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