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

Zhengzhou University

Status and phase: Enrolling; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Combination Product: neoadjuvant radiochemotherapy; Combination Product: cadonilizumab combined with neoadjuvant radiochemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07016724

TA2024-404-ESCC

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups, including a placebo group

Arm 1: cadonilizumab combined with neoadjuvant radiochemotherapy

Experimental group

Description:

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

Treatment:

Combination Product: cadonilizumab combined with neoadjuvant radiochemotherapy

Arm 2: neoadjuvant radiochemotherapy

Placebo Comparator group

Description:

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

Treatment:

Combination Product: neoadjuvant radiochemotherapy