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

A phase II study to evaluate the efficacy and safety of photodynamic therapy (PDT) for cT1 and T2 esophageal cancer in cases with surgery, chemoradiotherapy, or endoscopic treatment is difficult to perform or standard treatments are refused.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032240616

Enrollment

Registered

2025-01-16

Start date

2025-01-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cT1 and T2 esophageal cancer where surgery, chemoradiotherapy, or endoscopic treatment is difficult Esophageal Cancer, Photodynamic therapy

Interventions

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

E02.186.500, E02.319.685, E02.774.722

Photodynamic therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Local tumor control rate 24 weeks after PDT treatment	—

Secondary

Measure	Time frame
Safety Progression free survival Overall survival	—

Contacts

Public ContactTakuma Higurashi

Yokohama City University Hospital

takuma_h@yokohama-cu.ac.jp+81-457872640

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026