Ivonescimab with short-course hypofractionated radiotherapy for second-line esophageal squamous cell carcinoma

Is this trial a fit for you?

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 prospective, single‑center, single‑arm Phase 2 study enrolling 37 patients who progressed on or were intolerant of first‑line systemic therapy. All participants will receive Ivonescimab in combination with short‑course hypofractionated radiotherapy, with no comparator group. The primary endpoints are progression‑free survival and safety; secondary endpoints include overall survival, duration of response, and objective response rate. Planned follow‑up extends across a two‑year study period to capture efficacy and adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* a. Patients with histologically confirmed esophageal squamous cell carcinoma (ESCC) , aged 18-80 years;
* b. Unresectable locally advanced, postoperative recurrent, or metastatic ESCC that has progressed on or is intolerant to first-line systemic therapy. For patients who received definitive concurrent chemoradiotherapy (CCRT) , disease progression during or within 6 months post-treatment is considered first-line treatment failure;
* c. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) . All positive regional lymph nodes are counted as a single lesion, while non-regional metastatic lymph nodes are counted per station;
* d. Adequate major organ function, defined as:

  1. Hematology:

     1. Hemoglobin (Hb) ≥ 90 g/L
     2. White blood cell (WBC) count ≥ 1.5 × 10⁹/L
     3. Platelet count ≥ 60 × 10⁹/L
  2. Serum biochemistry:

     1. Albumin ≥ 25 g/L
     2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN)
     3. Total bilirubin ≤ 1.5 × ULN
     4. Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min
  3. Echocardiography:

Left ventricular ejection fraction (LVEF) ≥ 50% (lower limit of normal)

* e. Eastern Cooperative Oncology Group (ECOG) performance status: 0-2;
* f. Expected survival ≥ 3 months;
* g. Voluntarily enrolled, with signed informed consent, and willing to comply with study protocols and follow-up.

Exclusion Criteria:

* a. Patients with severe organ dysfunction, uncontrolled acute infection, or significant comorbidities;
* b. Patients with vertebral metastases accompanied by spinal cord compression symptoms;
* c. Patients with esophagotracheal or esophagomediastinal fistulas;
* d. Patients with uncontrolled pleural, pericardial, or pelvic effusions requiring repeated drainage;
* e. Patients with esophageal primary/metastatic lesions invading the heart or great vessels, as assessed by the responsible physician, with a risk of life-threatening hemorrhage;
* f. Patients with esophageal primary/metastatic lesions invading the trachea or bronchi, as assessed by the responsible physician, with a risk of esophagotracheal fistula;
* g. Patients not suitable for short-course hypofractionated radiotherapy, as evaluated by the responsible physician;
* h. Pregnant or lactating women;
* i. Patients with mental disorders, or those with a history of psychotropic drug abuse and unable to quit;
* j. Patients who have participated in other drug clinical trials within the past 4 weeks;
* k. Patients or their families who refuse to participate in the study.

Where it's running

• Anhui Provincal Hospital
  Hefei, Anhui, China Recruiting

Study contacts

• Study coordinator: Huiquan Liu
• Email: 759821691@qq.com
• Phone: +86 15005518171

Similar studies

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

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• Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

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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.