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

NCT ID: NCT07016724

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2027-08-31

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: cadonilizumab combined with neoadjuvant radiochemotherapy

Subjects randomized in Arm 1 will be treated with cadonilizumab plus neoadjuvant radiochemotherapy before surgery.

Group Type: EXPERIMENTAL

cadonilizumab combined with neoadjuvant radiochemotherapy

Intervention Type: COMBINATION_PRODUCT

Subjects randomized to experimental arm will be treated with PD-1/CTLA-4 bi-antibody, termed as cadonilizumab, combined with neoadjuvant radiochemotherapy before surgery.

Arm 2: neoadjuvant radiochemotherapy

Subjects randomized in Arm 2 will be treated with neoadjuvant radiochemotherapy before surgery.

Group Type: PLACEBO_COMPARATOR

neoadjuvant radiochemotherapy

Intervention Type: COMBINATION_PRODUCT

Subjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

neoadjuvant radiochemotherapy

Subjects in the arm 2, the control arm, will be treated with neoadjuvant radiochemotherapy.

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

neoadjuvant radiochemotherapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Xiangbo Wan

Vice-president of the First Affiliated Hospital of Zhengzhou University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiangbo Wan

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Zhengzhou University

Locations

the First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Fuwei Wang

Role: CONTACT

wanxbo@zzu.edu.cn

0086-037166278517

Xiangbo Wan

Role: CONTACT

wanxbo@zzu.edu.cn

0086-037166271152

Facility Contacts

Xiangbo Wan, Ph.D

Role: primary

wanxbo@zzu.edu.cn

0086-037166271152

Other Identifiers

TA2024-404-ESCC

Identifier Type: -

Identifier Source: org_study_id