Neoadjuvant Radiochemotherapy Combined With Cadonilizumab for Local Advanced Esophageal Squamous Cell Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cadonilizumab combined with neoadjuvant radiochemotherapy, neoadjuvant radiochemotherapy.
- Who it may be relevant to
- Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Combination product cadonilizumab combined with neoadjuvant radiochemotherapy
Subjects randomized to experimental arm will be treated with PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy before surgery. - Combination product neoadjuvant radiochemotherapy
Subjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy.
Primary outcome measures
- pCR [Time frame: perioperative]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- diagnosed with other types of cancer during last five years;
- have a tendency to bleed;
- accepted any type of cancer-related therapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- the First Affiliated Hospital of Zhengzhou University — Zhengzhou
Identifiers
NCT: NCT07016724 · TA2024-404-ESCC