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New treatment option for Esophageal Squamous Cell Carcinoma
Official title Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07188103
What this study is testing
What is Ivonescimab+Radiotherapy?
Ivonescimab+Radiotherapy is an investigational medicine, being studied as a potential treatment for esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
- d. Adequate major organ function, defined as:
- Hematology:
You likely can't join if
- 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...
- f. Patients with esophageal primary/metastatic lesions invading the trachea or bronchi, as assessed by the responsible physician, with a risk of...
See the full eligibility 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...
- 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...
- d. Adequate major organ function, defined as:
- Hematology:
- Hemoglobin (Hb) ≥ 90 g/L
- White blood cell (WBC) count ≥ 1.5 × 10⁹/L
- Platelet count ≥ 60 × 10⁹/L
- Serum biochemistry:
- Albumin ≥ 25 g/L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.