Light therapy shows promise for tough esophageal cancer cases

NCT ID NCT06437288

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 198 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

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

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

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.

esophageal cancer Esophageal Neoplasms

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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.

    Open the record ↗

  3. 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

  • Endoscopic Department of Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

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