Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 75

Neoadjuvant radiochemotherapy with cadonilizumab for locally advanced esophageal squamous cancer

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

Run by The First Affiliated Hospital of Zhengzhou University · NCT07016724 · Data updated 2026-11-12

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.

More Esophageal Squamous Cell Carcinoma trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment208 (estimated)
SponsorThe First Affiliated Hospital of Zhengzhou University
Academic / other
Drugs / interventionscadonilizumab
Locations1 site (Zhengzhou, Henan)
StatusRecruiting
StartedAugust 15, 2024
Main results expectedAugust 31, 2026
Study endsAugust 31, 2027
Registry record updatedJune 12, 2025
Trial IDNCT07016724 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
  • Email: wanxbo@zzu.edu.cn
  • Phone: 0086-037166278517

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.