bile tube cancer
Conditions
Interventions
The test group:Arothini: 12 mg/tablet, 1 tablet at a time, 1 time a day, taken before meals (each take it at the same time as possible until the disease progresses or an insatient poison appears sex.
Control group:Gissinabin: 1000 mg/m2 , intravenous drips, every 14 days, every 2 weeks Day 1 intravenous drips, one cycle every 28 days, at least 4 cycles of treatment
Osali platinum: 100 mg/m2, intravenous drips, injections every 14 days, every 2 weeks Day 1 intravenous drips, one cycle every 28 days, at least&
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years old, male and female; 2. Non-excisible local advanced and/or metastatic advanced bile tube cancer as confirmed by histopathology or cell pathology; 3. has not previously received chemotherapy, immunotherapy and radiation interventional treatment (through in-arterial chemotherapy embolism, through in-arterial embolism, infusion through the arteries). Subjects with a recurrence of the disease at least 6 months after the end of the new assisted or assisted treatment may participate in the study. 4. ECOG PS score: 0-1 points; 5. the estimated survival period >= 12 weeks; 6. entering the study and the first day of week 1 before the drug has full hematoging function, defined as according to the white blood cell count >= 3.5 x 10^9 /L and the absolute count of neutral granulocytes >= 1.5 x 10^9 /L, Lymphocyte count >= 0.5 x 10^9 /L, plate plate count >= 100 x 10^9 /L, hemoglobin (Hgb) >= 9 g/dL. Subjects who had previous blood transfusions could participate in the study if they entered the study with hgb stability >= 9 g/dL. 7. with sufficient liver function, that is, total bililine level = 50 mL/min based on the Cockcroft-Gault formula or CrCl test using a 24-hour urine sample. 9. The original time of clotting enzyme or the original time of active partial clotting enzyme and the international standardized ratio <= 1.5 times ULN. 10, Child-Pugh liver function rating A or better B (<= 7). 11. Women of childbearing age should agree to use contraceptives (e.g. intraoral devices, contraceptives or condoms) during and within 6 months of the end of the study; 12. The subjects voluntarily joined the study, signed the informed consent, followed by good sex, and cooperated with follow-up. 13, the researchers believe that patients can benefit.
Exclusion criteria
Exclusion criteria: 1. Past and/or interstitity cancer. Cancer that has been cured and has not recurred for more than 3 years Or early cancers that have been cured, including but not limited to in-place cervical cancer, superficial, non-invasive bladder cancer, substrate cell carcinoma, in-place squamous cells cancer, or gastrointestinal tumors that are confined to the mucous membrane layer and have been removed under the endoscope. 2. Past and present have a history of pulmonary fibrosis, interstitity pneumonia, dust lung, radioactive lung inflammation, drug-related pneumonia, severe damage to lung function, etc. may interfere with suspicious drugs patients who are tested and treated for pulmonary toxicity; With a history of active tuberculosis infection within 48 weeks, whether treated or not; 3. There are clinical symptoms of the third gap fluid needs to be repeatedly drained, such as after pumping or its He was treated for heart build-up, chest fluid and celiac fluid that remained uncontable. 4. With central nervous system symptoms of brain metastasis patients. 5. Patients who have received allogeneic bone marrow transplants or solid organ transplants in the past; 6. 4 weeks before the first drug treatment with systemic immunostulation agent; 7. The presence of any active, known or suspected autoimmune disease; 8. 1 month before randomization, patients who had be vaccinated against tumors or other immunomodulation can act on drugs (e.g., white mesothionin-2, thymus peptides, mushroom polysaccharides, etc.), or patients who will be vaccinated against detoxification 9. 28 days before randomization, the use of corticosteroids (> 10 mg /day of peronisone or other equivalent hormones) or other immunosuppressants for systematic treatment of the subjects. Inhalation or partial use is permitted in the absence of active autoimmune diseases dorticosteroids, as well as adrenal 450 ms) and/or pacemaker implant history, or New York Cardiology Association III Level or LEVEL IV congestive heart failure/or roomic arrhyth arrhythmic, or left heart shot fraction 2000 units; hepatitis C virus antibody-positive, and HCV RNA positive, human immunodeficiency virus (HIV) positive; syphilis antibody positive. 16. liver transplant candidates and medically acceptable periods of time to receive tran
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS; | — |
Countries
China
Contacts
Public ContactZengZhiming
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed