A phase II study to explore the expansion of indications for photodynamic therapy (PDT) in cT1 and T2 esophageal cancer

JRCT ID: jRCTs032240616

Registered date:16/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cT1 and T2 esophageal cancer where surgery, chemoradiotherapy, or endoscopic treatment is difficult
• Date of first enrollment: 16/01/2025
• Target sample size: 38
• Study type: Interventional
• Intervention(s): Four to six hours after the administration of talaporfin sodium at 40 mg/m2, a laser irradiation of 100 J per 1 cm2 of esophageal cancer is performed

Outcome(s)

• Primary Outcome: Local tumor control rate 24 weeks after PDT treatment

Secondary Outcome

Safety
Progression free survival
Overall survival

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Diagnosed with esophageal cancer based on a pathological examination.
(2) The depth of invasion has been diagnosed as cT1 or T2 through CT, endoscopic ultrasound, or magnifying endoscopy.
(3) No lymph node metastasis or distant metastasis (N0M0) confirmed by CT, MRI, or PET.
(4) The standard treatment has been deemed difficult in a department conference or internal/external tumor board, or the patient has been fully informed about the standard treatment but has chosen not to pursue it.
(5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2

Exclude criteria

(1)Patients with a history of hypersensitivity to talaporfin sodium.
(2)Patients with porphyria.
(3)Women who are pregnant, breastfeeding, possibly pregnant, or wish to become pregnant during the treatment period.
(4)Patients with multiple cancers (if the other cancer is at a more advanced stage than the esophageal cancer and significantly affects the prognosis, treatment for the other cancer will be prioritized, and the patient will not be included in the trial. However, patients will not be excluded if early-stage cancers are present, where appropriate treatment may lead to a favorable long-term prognosis, considering the stage and prognosis of each cancer type).
(5)Other patients deemed unsuitable for inclusion by the physician's judgment.

Related Information

• Primary Sponsor: Higurashi Takuma
• Source(s) of Monetary Support: Yokohama City University Research Grant for the Promotion of Advanced Medicine