Esophageal Squamous Cell Carcinoma
Conditions
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.
Interventions
COMBINATION_PRODUCTcadonilizumab 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_PRODUCTneoadjuvant radiochemotherapy
Subjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy.
Sponsors
The First Affiliated Hospital of Zhengzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCR | perioperative | pathological complete response |
Countries
China
Contacts
Primary ContactFuwei Wang
Backup ContactXiangbo Wan
Outcome results
None listed