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Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors

Phase 1
18 Years
70 Years
Open (Enrolling)
Skin Cancer, Esophageal Cancer

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Trial Information

Safety Study of Photodynamic Therapy Using Photocyanine Injection in Treating Patients With Malignant Tumors

Photocyanine injection is a type of cyanine compound, which was invented in Fuzhou
university by Professor Chen; it's maximum absorption wave is 670 nm. Patients receive
intravenous injection of Photocyanine injection, and 24 hours later, patients undergo
photodynamic therapy.

Cohorts of 3-6 patients receive escalating doses of Photocyanine Injection and photodynamic
therapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 1 of 3 patients experiences dose-limiting toxicity. Three additional
patients are treated at the MTD.

After completion of study therapy, patients are followed for up to 2 weeks.

Inclusion Criteria:

1. Aged 18 to 70 years old (patient over 60 years old must not have three kinds of
complications of heart, lung, liver and kidney function at the same time), no gender

2. Advanced malignant solid tumors confirmed by histology or cytology ( skin cancer and
esophageal cancer), malignant tumor can be illuminated directly (or via endoscopy)
by the laser fiber;

3. Recurrence after surgery, radiotherapy,chemoradiotherapy; or have financial
difficulties, give up any other treatment;

4. Patients received chemotherapy, biological therapy or other research drugs must
exceed at least 4 weeks or more than five half-life;

5. Life expectancy: > 3 months;

6. Can collaboratively observe the adverse events and efficacy;

7. No other anti-tumor treatment (including steroids);

8. Patients or their legal representative can sign the informed consent;

9. Performance status: ECOG ≤ 2,

Exclusion Criteria:

1. No pathological evidence;

2. Have allergic effect to this drug;

3. HIV antibody positive, or suffering from other acquired and congenital immune
deficiency diseases, or have organ transplant history;

4. Neutrophil count < 1.5 × 109 / L, platelet < 100 × 109 / L, or hemoglobin < 90 g /L;

5. Serum Cr above 1.5 times of normal reference range or Cr clearance rate < 50 ml/min;

6. ALT, or AST > 2.5 times of the normal range when no hepatic metastasis occur; or ALT,
or AST > 5 times of the normal range when hepatic metastasis exist;

7. Serum bilirubin > 1.5 times of the normal range;

8. Fever above 38 ℃, or have active infection which can affect the clinical trials

9. Hypertension failed to be controlled (systolic blood pressure > 160 mmHg or diastolic
pressure > 100 mmHg);

10. Obvious cardiovascular disorders (eg, myocardial infarction, superior vena cava
syndrome, more than two grades heart disease, or heart disease which can increase the
risk of ventricular arrhythm);

11. Not recover from any anticancer therapy or surgery;

12. Any clinical problems beyond control (such as severe mental, neurological,
cardiovascular, respiratory system diseases, etc.);

13. Evidence of central nerve system metastasis;

14. Have some gastrointestinal disease which can affect the distribution, metabolism or
removal of this drug;

15. Pregnant or breast-feeding women;

16. Poor compliance.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

one month

Safety Issue:


Principal Investigator

guo l xu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University


China: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

April 2010

Related Keywords:

  • Skin Cancer
  • Esophageal Cancer
  • skin cancer
  • esophageal cancer
  • photodynamic therapy
  • Neoplasms
  • Skin Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms