Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

Launched by SUN YAT-SEN UNIVERSITY · May 26, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a treatment called photodynamic therapy (PDT) for patients with recurrent or leftover superficial esophageal cancer. The goal is to see if a specific medication, hematoporphyrin, can help completely eliminate the cancer by using a laser light therapy after the injection. Participants in this study will be adults aged 18 to 80 who have previously been treated for esophageal cancer but are still facing challenges with the disease.

If eligible, participants will receive an intravenous (IV) injection of hematoporphyrin, followed by laser treatment a few days later. They will be monitored for 28 days to see how well the treatment works and to evaluate their overall health, quality of life, and any side effects. It's important to note that this trial is not yet recruiting participants, and those interested will need to meet specific criteria, including having superficial esophageal cancer and being able to tolerate general anesthesia.

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Eligibility criteria

• 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.