Recruiting
Phase 2
Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
Condition(s) studied
Esophageal Squamous Cell Carcinoma
Investigational drug(s) / intervention(s)
Ivonescimab+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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Anhui Provincal Hospital |
Hefei |
Anhui |
Recruiting |
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