Promising combo targets tough esophageal cancer in small trial
NCT ID NCT07188103
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial is testing whether a drug called ivonescimab, given together with a short course of targeted radiation, can help people with advanced esophageal cancer that has worsened after first treatment. The study will enroll 37 adults and track how long they live without the cancer growing, as well as side effects. It is a single-center, single-arm study, meaning everyone gets the same treatment and there is no placebo group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ivonescimab (a monoclonal antibody) combined with short-course hypofractionated radiotherapy
- What this could lead to
- If successful, this could offer a new second-line treatment option for people with advanced esophageal cancer that has stopped responding to initial therapy.
- What could go wrong
- This is a small, early-phase trial with only 37 participants and no comparison group, so results may not be definitive. The combination may cause side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Provincal Hospital
RECRUITINGHefei, Anhui, 230000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Antibody-Drug conjugate targets advanced esophageal cancer after standard treatments fail
- Can a drug combo stop esophageal cancer from returning after surgery?
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Can a drug combo shrink esophageal tumors before surgery?
- Two-Drug combo targets esophageal cancer that outsmarted immunotherapy
- Can a Triple-Drug combo shrink esophageal tumors before surgery?