Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer
1 other identifier
interventional
208
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2024
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 15, 2024
CompletedFirst Submitted
Initial submission to the registry
February 11, 2025
CompletedFirst Posted
Study publicly available on registry
June 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
June 12, 2025
April 1, 2025
2 years
February 11, 2025
June 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
pCR
pathological complete response
perioperative
Study Arms (2)
Arm 1: cadonilizumab combined with neoadjuvant radiochemotherapy
EXPERIMENTALSubjects randomized in Arm 1 will be treated with cadonilizumab plus neoadjuvant radiochemotherapy before surgery.
Arm 2: neoadjuvant radiochemotherapy
PLACEBO COMPARATORSubjects randomized in Arm 2 will be treated with neoadjuvant radiochemotherapy before surgery.
Interventions
Subjects randomized to experimental arm will be treated with PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy before surgery.
Subjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- diagnosed with other types of cancer during last five years;
- have a tendency to bleed;
- accepted any type of cancer-related therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangbo Wan
The First Affiliated Hospital of Zhengzhou University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice-president of the First Affiliated Hospital of Zhengzhou University
Study Record Dates
First Submitted
February 11, 2025
First Posted
June 12, 2025
Study Start
August 15, 2024
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
June 12, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share