Neoadjuvant radiochemotherapy with cadonilizumab for locally advanced esophageal squamous cancer

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

This phase 2 test adds cadonilizumab (a PD‑1/CTLA‑4 bi‑specific antibody) to standard neoadjuvant radiochemotherapy to see if it improves outcomes for people with locally advanced esophageal squamous cell carcinoma who are planned for surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Zhengzhou University (Academic / other)
• Drugs / interventions: cadonilizumab
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT07016724 on ClinicalTrials.gov

What this trial studies

This phase 2, single‑center trial combines cadonilizumab with standard neoadjuvant radiochemotherapy for patients with locally advanced esophageal squamous cell carcinoma. Eligible, treatment‑naïve patients with cT1N+, or cT2–3N0–3M0 disease and ECOG 0–1 receive the immunotherapy plus chemoradiation prior to planned surgery, while a comparator arm receives radiochemotherapy alone. The study focuses on increasing pathological complete response rates and monitoring safety, with additional attention to surgical outcomes and survival metrics. All enrollment and treatment occur at The First Affiliated Hospital of Zhengzhou University in Zhengzhou, Henan.

Who should consider this trial

Good fit: Adults with histologically confirmed esophageal squamous cell carcinoma staged cT1N+ or cT2–3N0–3M0, who are treatment‑naïve, have ECOG 0–1, adequate organ function, and are candidates for neoadjuvant therapy followed by surgery are ideal for this protocol.

Not a fit: Patients with prior other cancers within five years, active bleeding tendencies, prior cancer therapy, poor organ function, or metastatic disease (M1) are unlikely to benefit from this neoadjuvant combination.

Why it matters

Potential benefit: If successful, the combination could raise preoperative complete tumor response rates and improve surgical and longer‑term outcomes for patients with locally advanced ESCC.

How similar studies have performed: Previous studies combining immune checkpoint inhibitors with neoadjuvant radiochemotherapy have reported pathological complete response rates around 50%, but using a PD‑1/CTLA‑4 bispecific antibody like cadonilizumab in this setting is relatively novel with limited published data.

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.

Where this trial is running

Zhengzhou, Henan

• the First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Xiangbo Wan — The First Affiliated Hospital of Zhengzhou University
• Study coordinator: Fuwei Wang

Conditions Esophageal Squamous Cell Carcinoma