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.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 208 (estimated) |
| Sponsor | The First Affiliated Hospital of Zhengzhou University Academic / other |
| Drugs / interventions | cadonilizumab |
| Locations | 1 site (Zhengzhou, Henan) |
| Status | Recruiting |
| Started | August 15, 2024 |
| Main results expected | August 31, 2026 |
| Study ends | August 31, 2027 |
| Registry record updated | June 12, 2025 |
| Trial ID | NCT07016724 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
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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.
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This study tests SKB500 combined with other drugs to see if it is safe and shows early signs of activity in adults with unresectable or metastatic esophageal squamous cell carcinoma who have limited prior treatment.
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Neoadjuvant Cardonilizumab With Chemotherapy Before Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma
This study tests whether adding cardonilizumab to preoperative chemotherapy (versus chemoradiotherapy) helps patients with locally advanced ESCC have a better chance at complete tumor removal and longer survival.
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Surgery or chemoradiotherapy after neoadjuvant immunochemotherapy for esophageal squamous cell carcinoma
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.