Hematoporphyrin Photodynamic Therapy for Esophageal Cancer

NCT ID: NCT06437288

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-18
• Study Completion Date: 2030-12-01

Brief 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

Conditions

Esophageal Cancer; Photodynamic Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

photodynamic therapy

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.

Group Type: EXPERIMENTAL

photodynamic therapy

Intervention Type: PROCEDURE

Receive an intravenous infusion of hematoporphyrin injection

Interventions

photodynamic therapy

Receive an intravenous infusion of hematoporphyrin injection

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jian-jun Li

Prefessor, Endoscopy Department Administrative Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Endoscopic Department of Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Jianjun - Li, Doctor

Role: CONTACT

lijj@sysucc.org.cn

+86-10-87343009 ext. 02087343009

Jianjun - Li, Doctor

Role: CONTACT

lijj@sysucc.org.cn

02087343009 ext. 02087343009

Facility Contacts

Professor Li, Doctor

Role: primary

lijj@sysucc.org.cn

01087343223

Yufan Chen, Doctor

Role: backup

chenyf1@sysucc.org.cn

02087346623

Jianjun Li, Doctor

Role: backup

Other Identifiers

2024-FXY-183

Identifier Type: -

Identifier Source: org_study_id