Advanced Liver Cancer
Conditions
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. All patients must meet one of the following criteria: (1) The advanced liver cancer patient with tumor lesion too large for surgery or is not suitable for surgery; (2) Three weeks after interventional treatment (TAE), the patients liver tumor is still alive; (3) Stage I to Phase III liver cancer patients, accompanied by a variety of reasons such as illness, age or physical can not tolerate or do not want surgery, chemotherapy and radiotherapy; (4) Patient with confirmed liver metastasis; (5) The patient with unresectable small size tumors scattered inside the liver is suitable for pin-point PTS injection necrotizing therapy that may create an opportunity for surgery, or reduce the size of surgical resection mass; 2. Required to confirm the diagnosis as the follows: (1) The patient with AFP =400ug/L must has biopsy confirmation; (2) The patient with AFP>400ug/L, and confirmed by CT/MR Enhanced examination may no require to do the histological biopsy; shall not be more than 20% among all subjects; (3) Patient with liver metastasis confirmed by histological biopsy; 3. All patients must be confirmed the site and location of target tumor lesions by image examination (CT/MR Enhanced) and the number of lesions should be less than 4; 4. The patient must have adequate tumor tissue for pathological biopsy examination (Percutaneous extraction biopsy); 5. The patient at least 18 years of age; 6. Female patients of child bearing potential must have a negative pregnancy test at study entry and must agree to use an acceptable form of birth control for the duration of the study; 7. The patient's ECOG Performance Status must be 0 to 3; 8. The patient's life expectancy to be estimated greater than 3 months; 9. The patient is able to tolerate localized injections of PTS; 10. Hepatic function grade A and B by child-pugh; 11. The patient has adequate bone marrow, renal, and hepatic function per the following criteria: Total WBC count>=3000/mm3; platelet count>=50*10^9/mm3; Serum creatinine=60 mL/min; 12. HIV to be negative; 13. The patient is capable of understanding and complying with the protocol and has signed the informed consent document.
Exclusion criteria
Exclusion criteria: 1. The patient has main branch of the inferior vena cava or the main branch of the portal vein tumor thrombus to be excluded; 2. The patient with lesions near important organs, blood vessels or with nerve adhesions to be excluded from the clinical trial; 3. Patient with severe concomitant diseases, including activities not control the infection or serious heart, liver, kidney or blood failure; 4. The patient is pregnant or lactating; 5. The patient has a known hypersensitivity to PTS or related compounds; 6. Interventional therapy (TAE) within three weeks of the patient; or patient in the four weeks before entering the trial and had advanced liver cancer systemic anticancer therapy, or 6 weeks ever used the nitrosourea (Nitrosourea) or mitomycin -C systemic treatment; 7. The patient has participated in clinical studies of non-approved experimental agents or procedures within 4 weeks prior to study entry; 8. The patient has a history of malignancies other than the study malignancy, unless the patient was curatively treated and has been disease free for greater than 2 years; 9. The patient has had prior autologous or allogeneic transplant; 10. The patient four weeks before entering the trial received radiotherapy and chemotherapy, biological anti-cancer, is not allowed into the clinical trial; 11. The patient has any other life-threatening complications; 12. The patient is unwilling to comply with study procedures, as specified by this protocol, or is unwilling to cooperate fully with the investigator; 13. Any other reasons rationalized by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Evaluation (RECIST & WHO Standard);Enhanced CT Efficacy Evaluation of the Blood Flow;Change of AFP; | — |
Secondary
| Measure | Time frame |
|---|---|
| ECOG;QOL;Safety Evaluation; | — |
Countries
China
Contacts
Public ContactGuang-Wei Xu
Outcome results
None listed