Patients with solid tumors
Conditions
Interventions
Escalation group:Divided into 4 groups for treatment
Expansion group:1~2 appropriate doses
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients, 18~80 years of age (contained boundary values); 2. Patients with solid tumors suitable for photodynamic therapy; 3. Patients with failed, recurrent, refractory or refuse routine treatments; 4. Patients at least 4 weeks after accepting last operative treatment, and at least 2 weeks after accepting chemotherapy, immunotherapy, endocrinotherapy, or targeted therapy (at least 8 weeks after stopping Adriamycin); 5. Expectation survival>=3 months; 6. Without serious hematopoietic or heart, lung, liver, kidney dysfunction and without immune deficiency; 7. Performance status ECOG with 0~1 score; 8. Can cooperate to observe adverse events and drug efficacy, and can allow bio-sample collection for pharmacokinetics under the investigators evaluation; 9. Volunteer to participate in this clinical trial, understand the study procedures and patients or legal representatives of them can sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Be allergic to study drugs; 2. Accept other antitumor drugs (e.g. chemotherapy, immunotherapy, endocrinotherapy, targeted therapy or other therapies) during the treatment of this clinical study; 3. Failed in previous photosensitizer treatment, or accepted other photosensitizers within 12 months before enrollment; 4. Accepted other photosensitive drugs (e.g. Tetracycline antibiotics, sulfonamides, phenothiazines, sulfonylureas, thiazide diuretics, and griseofulvin) within 4 weeks before initial administration; 5. Accepted radiotherapy on primary foci within 3 months before participating in this trial, or on non-treatment parts within 1 month before participating in this trial; 6. Joined in any other clinical trials (as subjects) within 1 month before participating in this trial, or occurred active bleeding within 3 months; 7. Neutrophil count3 times of upper limit of normal (ULN), or creatinine clearance rate3 times of ULN, or>5 times of ULN for patients with liver metastasis; 10. Serum bilirubin>3 times of ULN; 11. Patients with serious diseases, including serious heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, serious infection, active digestive ulcer and etc.; 12. Patients with different mental disorders; 13. Administered special diets (such as pitaya, mango, grapefruit, and/or xanthine diet, chocolate, or any foods/drinks with caffeine like tea or coffee), exercised strenuously, or has other factors which could affect the absorption, distribution, metabolism and excretion of study drug within 2 weeks before initial administration; 14. Women in pregnancy or lactation; female subjects without effective contraception measures or with fertility plan in 1 year; male subjects without effective contraception measures or their spouses with fertility plan in 1 year; 15. Patients with HIV, HCV, syphilis or who are positive to hepatitis B surface antigen and e antigen; 16. Be considered as low compliance, or have other unsuitable reasons for this clinical trial; 17. Patients whose family and investigators do not agree to join in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Evaluation Indicator; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation Indicators; | — |
Countries
China
Contacts
Public ContactShen Lin
Beijing Cancer Hospital
Outcome results
None listed