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Ivonescimab Plus Short-Course Hypofractionated Radiotherapy as Second-Line Therapy for Esophageal Squamous Cell Carcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT07188103•Anhui Provincial Hospital

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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
+8 more criteria

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;
+1 more criteria

Locations (1)

Anhui Provincal Hospital

Hefei, Anhui, China

Key Dates

Start Date

July 1, 2025

Primary Completion Date

June 30, 2027

Completion Date

June 30, 2027

Last Updated

September 23, 2025

Enrollment

ESTIMATED participants

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Ivonescimab+Radiotherapy

DRUG

Contacts

Huiquan Liu

CONTACT

+86 15005518171 759821691@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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