NCT07188103 Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
| NCT ID | NCT07188103 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Anhui Provincial Hospital |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 37 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 37 participants in total. It began in 2025-07-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07188103 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07188103 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07188103 currently recruiting?
Yes, NCT07188103 is actively recruiting participants. Contact the research team at 759821691@qq.com for enrollment information.
Where is the NCT07188103 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07188103 clinical trial?
NCT07188103 is sponsored by Anhui Provincial Hospital. The trial plans to enroll 37 participants.