Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

Trial Title: Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

NCT ID: NCT06437288

Condition: Esophageal Cancer
Photodynamic Therapy

Conditions: Official terms:
Esophageal Neoplasms

Study type: Interventional

Study phase: Phase 4

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: photodynamic therapy
Description: Receive an intravenous infusion of hematoporphyrin injection
Arm group label: photodynamic therapy

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. 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

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Endoscopic Department of Sun Yat-Sen University Cancer Center

Address:
City: Guangzhou
Zip: 510060
Country: China

Contact:
Last name: Professor Li, Doctor

Phone: 01087343223
Email: lijj@sysucc.org.cn

Contact backup:
Last name: Yufan Chen, Doctor

Phone: 02087346623
Email: chenyf1@sysucc.org.cn

Contact backup:
Last name: Jianjun Li, Doctor

Start date: September 18, 2024

Completion date: December 1, 2030

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06437288