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Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma

ConditionEsophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAnhui Provincial Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Hemoglobin (Hb) ≥ 90 g/L

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Ivonescimab+Radiotherapy

    Drug

    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.

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Ivonescimab+RadiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PFS

progression free survival

Time frame
From date of enrollment until the date of first documented progression (radiologic or clinical), assessed every 8 weeks up to 36 months
2

Advese Events

Advese Events

Time frame
Assessed every 8 weeks up to 36 months from the date of enrollment

Secondary outcomes

1

OS

overall survival

Time frame
From date of enrollment until the date of death from any cause, assessed up to 36 months
2

ORR

Objective Response Rate

Time frame
From enrollment to the time of the second radiological evaluation
3

DOR

Duration of Response

Time frame
the period from the first assessment of Complete Response (CR) or Partial Response (PR) to the first occurrence of Progressive Disease (PD) or death.
4

DCR

Disease Control Rate

Time frame
From enrollment to the time of second radiological evaluation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anhui Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov
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