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Clinical Trial NCT07188103 for Esophageal Squamous Cell Carcinoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma Phase 2 37 Immunotherapy Overall Survival

Recruiting
Clinical Trial NCT07188103 is designed to study Treatment for Esophageal Squamous Cell Carcinoma. It is a Phase 2 interventional study that is recruiting, having started on July 1, 2025, with plans to enroll 37 participants. Led by Anhui Provincial Hospital, it is expected to complete by June 30, 2027. The latest data from ClinicalTrials.gov was last updated on September 23, 2025.
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...Show More
Official Title

Efficacy and Safety of Ivonescimab Combined With Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma: A Prospective, Single-Center, Single-Arm Phase II Clinical Study

Conditions
Esophageal Squamous Cell Carcinoma
Other Study IDs
  • 2025KY-296
NCT ID Number
NCT07188103
Start Date (Actual)
2025-07-01
Last Update Posted
2025-09-23
Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
37
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Esophageal cancer
Hypofractionated Radiotherapy
Ivonescimab
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalIvonescimab+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.
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
PFS
progression free survival
From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months
Advese Events
Advese Events
Assessed every 8 weeks up to 36 months from the date of enrollment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
OS
overall survival
From date of enrollment until the date of death from any cause, assessed up to 36 months
ORR
Objective Response Rate
From enrollment to the time of the second radiological evaluation
DOR
Duration of Response
the period from the first assessment of Complete Response (CR) or Partial Response (PR) to the first occurrence of Progressive Disease (PD) or death.
DCR
Disease Control Rate
From enrollment to the time of second radiological evaluation
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  • 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.

  • 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.
Anhui Provincial Hospital logoAnhui Provincial Hospital
Study Central Contact
Contact: Huiquan Liu, +86 15005518171, [email protected]
1 Study Locations in 1 Countries

Anhui

Anhui Provincal Hospital, Hefei, Anhui, 230000, China
Recruiting