Concept image of a white device emitting red light; not actual equipment

Photoimmunotherapy-related Information in Japan

The actual drugs and device behind what the clinic calls “photoimmunotherapy”, with approval status and cost separated.

Illustrative image

Summary

Gan Chuo Clinic Group uses the name “cancer photoimmunotherapy” for a method combining the near-infrared device Super Lizer EX with ICG liposomes and talaporfin liposomes. The clinic states that the method includes drugs or devices not approved in Japan and is not covered by public insurance. Its name resembles a head and neck cancer treatment that received conditional early approval in Japan, but no basis was found for treating them as the same therapy.

Key terms and basic concepts

Photodynamic therapy (PDT) is a general term for treatments in which a light-sensitive drug is given and then activated by light of a specific wavelength.

The name “photoimmunotherapy” may refer to different drugs and methods at different institutions. Do not assume two treatments are the same by name; confirm the drug, device and approval status.

Approved PDT-related drugs in Japan as listed by the source: porfimer sodium (1994), talaporfin sodium (2003), and cetuximab sarotalocan sodium (conditional early approval in 2020 for unresectable locally advanced or locally recurrent head and neck cancer).

Method as described in the source (institution’s public materials)

Institution’s description

  • Device: Super Lizer EX by Tokyo Iken. The clinic describes LED probes in the 600–1000 nm wavelength band.
  • Drugs: ICG liposomes and talaporfin liposomes. Liposome manufacture is outsourced and final preparation is done in the clinic.
  • Schedule: one course is basically five outpatient visits over about a month; it may end after one course or continue.
  • The clinic states it does not require medical records and checks effects by blood tests.

What to confirm with the medical team

  • Exact names and approval status of the drugs and device used
  • Differences from the similarly named approved treatment using cetuximab sarotalocan sodium
  • Whether it can be combined with current treatment, and how information is shared with your doctor
  • What is used to evaluate effect, and when
  • Criteria for additional courses and total cost

Limitations, risks and precautions

  • The clinic says nearly all cancer types and stages can be treated, but this check found no independent clinical evidence supporting that claim.
  • Side effects listed by the clinic: allergic reaction or anaphylaxis (0.3% per the clinic), infusion-related haematoma or nerve injury, and possible sunburn for about a week.
  • The clinic itself states there is no approved drug in Japan with the same ingredients or performance as its ICG and talaporfin liposomes.
  • Public relief schemes in Japan may apply differently to care using unapproved drugs or devices; confirm with the institution.

Regulatory, approval and cost information

ItemDetails
Approval statusInstitution’s description
The clinic states that procedures using drugs or devices unapproved in Japan are included.
Public insuranceInstitution’s description
Not covered (self-pay).
CostInstitution’s description
¥2,200,000 per course (five visits, about one month), tax included; the same per subsequent course. Amount as posted by the clinic on the check date.
Similarly named approved therapyAuthoritative source
A head and neck cancer treatment using cetuximab sarotalocan sodium received conditional early approval in 2020. It uses a different drug from the clinic’s method.
Advanced Medical Care statusNot confirmed
No information confirmed that this method falls under Advanced Medical Care.
Evidence of effectLimited evidence / research stage
Beyond the clinic’s description, no published clinical trial results for this method were confirmed in this check.

Questions to ask the medical team

  1. Are the drugs and device used approved in Japan?
  2. How does this differ from treatment using cetuximab sarotalocan sodium?
  3. What criteria and timing are used to judge the effect?
  4. What are the risks when combined with my current treatment?
  5. How are costs handled if treatment stops or is not effective?

Source links and check date

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