Light therapy shows promise for tough esophageal cancer cases
NCT ID NCT06437288
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a treatment called photodynamic therapy (PDT) for people whose superficial esophageal cancer has come back or remained after standard treatments. Patients receive an injection of hematoporphyrin, a drug that makes cancer cells sensitive to light, then a laser is used to activate it. The goal is to see if this can completely eliminate the tumor by day 56. The study enrolls 198 adults aged 18-80.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hematoporphyrin injection
- What this could lead to
- If successful, this could offer a non-surgical option to eliminate remaining or returning superficial esophageal cancer after prior treatments.
- What could go wrong
- This is a single-arm study with no comparison group, so results may be less definitive. The treatment involves a photosensitizer, which can cause skin sensitivity to light and other side effects.
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 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 198 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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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: * 1\. Age between 18 and 80 years (inclusive of both 18 and 80 years), with no restrictions on gender. 2.Patients with esophageal squamous cell carcinoma who have undergone prior treatment, including radiotherapy, chemotherapy, immunotherapy, or surgical intervention (esophagectomy or endoscopic esophageal cancer surgery), with pathological confirmation of recurrence or residual disease (at least of high-grade intraepithelial neoplasia or above). 3.Patients with superficial esophageal cancer, where the primary lesion is located in the mucosal or submucosal layer, and the muscular layer is still intact, as indicated by ultrasound endoscopy and related examinations. 4.Subjects capable of tolerating general anesthesia. 5.Absence of severe hematological, coagulation, cardiac, pulmonary, hepatic, renal, or immunological abnormalities. 6.Voluntary consent to participate in the clinical trial after being fully informed about the purpose, process, potential risks, and benefits of the trial, including the subject's obligations. Exclusion Criteria: 1. Known allergy to the study medication or related drugs. 2. Patients who have not recovered from the toxicities associated with prior radiotherapy or chemotherapy treatments. 3. Previous treatment with other photosensitizers that was ineffective, or subjects who have received a photosensitizer treatment within 12 months prior to enrollment. 4. Use of other photosensitizing medications within 4 weeks prior to administration, such as tetracycline antibiotics, sulfonamides, and phenothiazines. 5. Neutrophil count \<1.5×10\^9 /L, platelet count \<100×10\^9 /L, or hemoglobin \<100 g/L. 6. Serum creatinine ≥3 times the upper limit of normal or creatinine clearance \<60 ml/min/1.73m\^2; ALT or AST \>3 times the upper limit of normal; or in the case of liver metastasis, ALT or AST \>5 times the upper limit of normal; serum bilirubin \>3 times the upper limit of normal. 7. Presence of severe comorbid conditions, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, and uncontrolled hypertension. 8. HIV, HCV, syphilis infection, or positive for both hepatitis B surface antigen and e antigen. 9. Active esophageal inflammation (especially visible active ulcers, hyperemia, necrosis, etc. under endoscopy) or clinically significant active infection symptoms. 10. Pregnant or lactating women, and sexually active subjects of childbearing potential (including males) who refuse to use appropriate contraceptive measures during the study. 11. Active bleeding or bleeding diathesis (abnormal coagulation mechanism). 12. Severe physical or mental illness that may affect treatment, assessment, or compliance with the study protocol. 13. Concurrent second primary tumor undergoing treatment. 14. Single lesion greater than 5cm in length.
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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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Endoscopic Department of Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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Other studies related to the condition(s) this trial covers.
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- A single blood draw to detect five cancers before symptoms appear?
- Can custom vitamin pills fix nutrient gaps after stomach or esophageal cancer surgery?
- Can repeated MRI scans reveal how tumors respond to radiation?