Ivonescimab plus chemotherapy before surgery for resectable esophageal squamous cell cancer
Official title: A Prospective, Single-arm, Single-center, Exploratory Study of the Safety and Efficacy of Ivonescimab(AK112) Combined With Chemotherapy in Patients With Resectable Esophageal Squamous Cell Carcinoma
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07244978 · Data updated 2026-11-12
This study tests whether giving Ivonescimab together with chemotherapy before esophageal cancer surgery helps patients see better outcomes than surgery alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 49 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | Ivonescimab, chemotherapy, immunotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | June 3, 2026 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2032 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07244978 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 with primary resectable esophageal squamous cell carcinoma, clinical stage II–IVA, ECOG 0–1, no distant metastasis, and suitable for neoadjuvant therapy and surgery.
✕Probably not a fit
Patients with significant cardiovascular disease, active autoimmune conditions, or those who develop intolerance to the treatment could derive little or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 2, single-arm trial evaluating neoadjuvant Ivonescimab (AK112) combined with chemotherapy for patients with resectable esophageal squamous cell carcinoma. Participants receive Ivonescimab with albumin-bound paclitaxel and carboplatin before undergoing esophagectomy. The goal is to see if this perioperative strategy can improve tumor control and potentially survival by addressing systemic disease and local tumor burden. Safety, feasibility, and preliminary signals of efficacy will be assessed through surgical outcomes and pathological responses. The study is conducted at a single center in China and targets adults with localized disease who are candidates for curative resection.
Why it matters
Potential benefit: If successful, patients may have a higher likelihood of tumor shrinkage before surgery and potentially better overall outcomes after resection.
How similar studies have gone: Previous approaches combining PD-1/PD-L1 inhibition with anti-VEGF strategies have shown promise in ESCC, but this exact neoadjuvant combination is investigational and exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. signed informed consent; 2. patients age 18 to 75 years old 3. primary resectable, histologically confirmed esophageal squamous cell cancer; 4. Esophageal squamous cell carcinoma the clinical stage was II-IVA (according to AJCC TNM stage, 8th edition). 5. ECOG PS 0-1. 6. No distant metastasis, the diseases could be resectable assessed by thoracic oncologist; Exclusion Criteria: 1. with significant cardiovascular disease; 2. current treatment with anti-viral therapy or HBV; 3. Female patients who are pregnant or lactating; 4. history of malignancy within 5 years prior to screening; 5. active or history of autoimmune disease or immune deficiency; 6. signs of distant metastases.
Where it's running
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The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Zixiang Wu, M.D
- Email: zixiang0717@zju.edu.cn
- Phone: +8615268156132
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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.