Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Esophageal cancer, Hypofractionated Radiotherapy, Ivonescimab
Brief summary
In the era of immunotherapy, the standard second-line treatment regimen for locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) remains controversial. This prospective, single-center, single-arm phase II clinical study aims to evaluate the efficacy and safety of Ivonescimab combined with short-course hypofractionated radiotherapy as a second-line therapy for patients with locally advanced/metastatic ESCC. The study plans to enroll 37 patients who have failed first-line treatment, without grouping, all of whom will receive Ivonescimab combined with short-course hypofractionated radiotherapy. The primary endpoints are progression-free survival (PFS) and safety, while the secondary endpoints include overall survival (OS), duration of response (DOR), and objective response rate (ORR). The study duration is 2 years.
Interventions
DRUGIvonescimab+Radiotherapy
Short-course hypofractionated radiotherapy was administered to progressive lesions after first-line treatment, with a prescribed dose of 20 Gy in 5 fractions (95% PTV). The monoclonal antibody was initiated within 1 week after completing the radiotherapy regimen, at a dose of 20 mg/kg. Ivonescimab was administered every three weeks until disease progression, intolerable toxicity, or patient refusal.
Sponsors
Anhui Provincial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months | progression free survival |
| Advese Events | Assessed every 8 weeks up to 36 months from the date of enrollment | Advese Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | From enrollment to the time of second radiological evaluation | Disease Control Rate |
| DOR | the period from the first assessment of Complete Response (CR) or Partial Response (PR) to the first occurrence of Progressive Disease (PD) or death. | Duration of Response |
| OS | From date of enrollment until the date of death from any cause, assessed up to 36 months | overall survival |
| ORR | From enrollment to the time of the second radiological evaluation | Objective Response Rate |
Countries
China
Contacts
Primary ContactHuiquan Liu
Outcome results
None listed