Could a blood vessel blocker boost esophageal cancer treatment?
NCT ID NCT06281886
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This phase 2 trial tests whether adding the drug apatinib to standard chemotherapy and radiation helps people with advanced esophageal cancer that cannot be removed by surgery. About 170 participants will receive either the standard treatment or the standard treatment plus apatinib. The study tracks how long the cancer stays under control and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Apatinib (a drug that blocks blood vessel growth to tumors)
- What this could lead to
- If successful, adding apatinib could improve how long patients live without their cancer growing, offering a new option for hard-to-treat esophageal cancer.
- What could go wrong
- This is a mid-stage trial with only 170 people, so results may not apply to everyone. Apatinib can cause side effects like high blood pressure or bleeding, and the added benefit over standard therapy is not yet proven.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
170 people
The number who actually took part.
- Started
-
Feb 2024
- Finished
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Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
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: * Diagnosed with esophageal squamous cell carcinoma through pathological examination or cytological examination; * Evaluated as locally advanced esophageal cancer that is unresectable through endoscopic ultrasound, imaging studies including barium swallow, CT scans of the neck, chest, and upper abdomen, MR imaging of the neck and chest, whole-body bone scan, or PET/CT, with staging ranging from T2-4, N0-3, M0-1 (M1 only includes patients with supraclavicular lymph node metastasis); * Male or female aged between 18 and 80 years old; * No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy; * Expected survival of ≥12 weeks; * ECOG performance status score of 0 or 1; * Organ and bone marrow function meeting the following criteria: forced expiratory volume in 1 second (FEV1) ≥800 ml; absolute neutrophil count ≥1.5×109/L; platelet count ≥100×109/L; hemoglobin ≥90 g/L; serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); aspartate aminotransferase and alanine aminotransferase ≤2.5 times ULN; * Signed and dated informed consent form is required before any study procedures are performed. Exclusion Criteria: * Participating in another clinical study concurrently, unless it is an observational (non-interventional) clinical study; * Prior use of any targeted therapy or immunotherapy; * Underwent major surgery (excluding vascular access) within 4 weeks before entering the study; * Uncontrolled complications, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, intestinal perforation, intestinal obstruction, active bleeding disorders, or psychiatric illness/social situations that would limit compliance with study requirements or impair the ability to provide written informed consent; * Performance status score of 2-4; * Any of the following organ and bone marrow dysfunctions: forced expiratory volume in 1 second (FEV1) \<1000ml; absolute neutrophil count \<1.5×109/L; platelet count \<100×109/L; hemoglobin \<90 g/L; serum creatinine clearance calculated according to the Cockcroft-Gault formula \<50 mL/min (Cockcroft and Gault 1976); serum bilirubin \>1.5 times the upper limit of normal (ULN); aspartate aminotransferase and alanine aminotransferase \>2.5 times ULN; * Conditions that may interfere with the assessment of the efficacy or safety of apatinib; * Use of immunosuppressive drugs within 28 days before the first infusion of trastuzumab, excluding physiologic doses of inhaled corticosteroids; or systemic corticosteroids ≤10 mg/d of prednisone or equivalent; * History of autoimmune diseases within the past 2 years; * History of active or inflammatory bowel disease (such as Crohn's disease, ulcerative colitis); * History of organ transplantation requiring immunosuppressive therapy; * Receipt of attenuated live vaccines within 30 days before the study initiation or within 30 days after receiving trastuzumab; * History of another primary malignancy within 5 years before starting trastuzumab, except adequately treated basal or squamous cell skin cancer or in situ cervical cancer; * Pregnant or lactating females; or sexually active males or females of reproductive potential not using effective contraception methods.
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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.
Contacts and locations
Locations
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Sun yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, 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?