Esophageal CancerPhase 4NCT06437288
Hematoporphyrin Photodynamic Therapy for Esophageal Cancer
A Phase 4 study testing photodynamic therapy in people with Esophageal Cancer and Photodynamic Therapy, run by Sun Yat-sen University at 1 site in China.
Trial summary
The objective of the present clinical trial is to assess the efficacy of photodynamic therapy (PDT) employing hematoporphyrin injection in the management of recurrent or residual superficial esophageal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer, Photodynamic Therapy
- What is being tested?
- photodynamic therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 18 Sep 2024to 1 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known allergy to the study medication or related drugs.
- Patients who have not recovered from the toxicities associated with prior radiotherapy or chemotherapy treatments.
- Previous treatment with other photosensitizers that was ineffective, or subjects who have received a photosensitizer treatment within 12 months prior to enrollment.
- Use of other photosensitizing medications within 4 weeks prior to administration, such as tetracycline antibiotics, sulfonamides, and phenothiazines.
- Neutrophil count \<1.5×10^9 /L, platelet count \<100×10^9 /L, or hemoglobin \<100 g/L.
- 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.
Show all 14Show fewer
- Presence of severe comorbid conditions, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, and uncontrolled hypertension.
- HIV, HCV, syphilis infection, or positive for both hepatitis B surface antigen and e antigen.
- Active esophageal inflammation (especially visible active ulcers, hyperemia, necrosis, etc. under endoscopy) or clinically significant active infection symptoms.
- Pregnant or lactating women, and sexually active subjects of childbearing potential (including males) who refuse to use appropriate contraceptive measures during the study.
- Active bleeding or bleeding diathesis (abnormal coagulation mechanism).
- Severe physical or mental illness that may affect treatment, assessment, or compliance with the study protocol.
- Concurrent second primary tumor undergoing treatment.
- Single lesion greater than 5cm in length.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Endoscopic Department of Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
About this study
Official title: Real-World Study of Hematoporphyrin Injection-Based Photodynamic Therapy in Patients With Recurrent or Residual Superficial Esophageal Cancer
The objective of the present clinical trial is to assess the efficacy of photodynamic therapy (PDT) employing hematoporphyrin injection in the management of recurrent or residual superficial esophageal carcinoma. The principal objective is to determine the capability of this therapeutic modality to elicit a complete response in the patient cohort under investigation.
The central research question that this study seeks to address is as follows:
Read more
What is the rate of complete response at day 28 following treatment with photodynamic therapy utilizing hematoporphyrin injection in patients suffering from recurrent or residual superficial esophageal cancer? This study is designed as a single-arm trial, devoid of a control or comparison group.
Eligible participants will meet the following criteria:
They will be adult patients, aged between 18 and 80 years, who have experienced recurrence or retention of superficial esophageal cancer subsequent to prior therapeutic interventions.
They will receive an intravenous administration of hematoporphyrin injection at a dosage of 3mg/kg over a duration of 60 minutes.
They will undergo irradiation with a 630nm laser, which will be administered 48-72 hours post-infusion.
Their response to treatment will be evaluated at day 28 post-therapy, with assessments encompassing complete response, progression-free survival, overall survival, swallowing functionality, quality of life, and the incidence of adverse events throughout the duration of the study
- Conditions
- Esophageal Cancer, Photodynamic Therapy
- Being tested
- photodynamic therapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photodynamic therapyProcedure or surgery
Receive an intravenous infusion of hematoporphyrin injection
| Study group | Role | What they receive |
|---|---|---|
| photodynamic therapy | Experimental | Receive an intravenous infusion of hematoporphyrin injection at a dose of 3mg/kg over 60 minutes.
Undergo 630nm laser irradiation 48-72 hours after the infusion. Receives: Procedure: photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete response rate evaluated by endoscopic ultrasound (EUS)
The proportion of patients showing a complete disappearance of the tumor following the treatment, as assessed by EUS on day 56
Measured: 56 days after the treatment.
Secondary outcomes (5)
Progression free survival
Length of time during and after the treatment of a disease, in which a patient lives with the disease but it does not get worse.
Measured: 3 years
Overall survival
length of time from the start of the treatment until the death of the patient, regardless of the cause.
Measured: 3 years
Adverse events
Adverse events of the treatment.
Measured: 1 month after the treatment
Quality of life evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)
The Quality of life evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30) assesses cancer patients' quality of life with 30 items in functional and symptom scales scored 1-3, and a global health scale scored 1-7. Higher scores on functional/global health scales indicate better quality of life, while higher symptom scores mean worse outcomes. The scale's minimum and maximum scores vary by the number of items in each scale, with transformation to a 0-100 scale for standardization.
Measured: 0.5 year; 1 year; 3 year
Stooler's dysphagia grading
Stooler's dysphagia grading, in its full title, is known as the Stooler's Dysphagia Scale. This scale is used to assess the severity of dysphagia, which is difficulty or discomfort in swallowing. The Stooler's scale categorizes dysphagia into five grades, ranging from Grade 0 to Grade 4, with higher grades indicating more severe dysphagia.
Here is a breakdown of the Stooler's Dysphagia Scale:
Grade 0: No difficulty in swallowing. Grade 1: Occasional difficulty in swallowing solids. Grade 2: Occasional difficulty in swallowing liquids and frequent difficulty with solids.
Grade 3: Complete inability to swallow solids and frequent difficulty with liquids.
Grade 4: Inability to swallow any oral intake. In this scale, a lower grade indicates a better outcome, as it signifies less difficulty in swallowing. Conversely, a higher grade indicates a worse outcome, with Grade 4 being the most severe, indicating the inability to swallow anything orally.
Measured: 0.5 year; 1 year; 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start18 Sep 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-jun Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437288
- Sponsor's protocol ID
- 2024-FXY-183
- Status last verified
- May 2026
- First submitted
- 21 May 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Study of Hematoporphyrin Injection-Based Photodynamic Therapy in Patients With Recurrent or Residual Superficial Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06437288
- Acronym / sponsor ID
- 2024-FXY-183
- Conditions
- Esophageal Cancer, Photodynamic Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 18 Sep 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the present clinical trial is to assess the efficacy of photodynamic therapy (PDT) employing hematoporphyrin injection in the management of recurrent or residual superficial esophageal carcinoma. The principal objective is to determine the capability of this therapeutic modality to elicit a complete response in the patient cohort under investigation.
The central research question that this study seeks to address is as follows:
What is the rate of complete response at day 28 following treatment with photodynamic therapy utilizing hematoporphyrin injection in patients suffering from recurrent or residual superficial esophageal cancer? This study is designed as a single-arm trial, devoid of a control or comparison group.
Eligible participants will meet the following criteria:
They will be adult patients, aged between 18 and 80 years, who have experienced recurrence or retention of superficial esophageal cancer subsequent to prior therapeutic interventions.
They will receive an intravenous administration of hematoporphyrin injection at a dosage of 3mg/kg over a duration of 60 minutes.
They will undergo irradiation with a 630nm laser, which will be administered 48-72 hours post-infusion.
Their response to treatment will be evaluated at day 28 post-therapy, with assessments encompassing complete response, progression-free survival, overall survival, swallowing functionality, quality of life, and the incidence of adverse events throughout the duration of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| photodynamic therapy | Experimental | Procedure: photodynamic therapyReceive an intravenous infusion of hematoporphyrin injection at a dose of 3mg/kg over 60 minutes. Undergo 630nm laser irradiation 48-72 hours after the infusion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- Known allergy to the study medication or related drugs.
- Patients who have not recovered from the toxicities associated with prior radiotherapy or chemotherapy treatments.
- Previous treatment with other photosensitizers that was ineffective, or subjects who have received a photosensitizer treatment within 12 months prior to enrollment.
- Use of other photosensitizing medications within 4 weeks prior to administration, such as tetracycline antibiotics, sulfonamides, and phenothiazines.
- Neutrophil count \<1.5×10^9 /L, platelet count \<100×10^9 /L, or hemoglobin \<100 g/L.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photodynamic therapyReceive an intravenous infusion of hematoporphyrin injection | Procedure or surgery | photodynamic therapy |
Primary outcome
The complete response rate evaluated by endoscopic ultrasound (EUS)
Time frame: 56 days after the treatment.
The proportion of patients showing a complete disappearance of the tumor following the treatment, as assessed by EUS on day 56
5 secondary outcomes
Progression free survival
Time frame: 3 years
Overall survival
Time frame: 3 years
Adverse events
Time frame: 1 month after the treatment
Quality of life evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30(EORTC QLQ-C30)
Time frame: 0.5 year; 1 year; 3 year
Stooler's dysphagia grading
Time frame: 0.5 year; 1 year; 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing photodynamic therapy in people with Esophageal Cancer and Photodynamic Therapy, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complete response rate evaluated by endoscopic ultrasound (EUS) (time frame: 56 days after the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.