Advanced malignant solid tumors
Conditions
Interventions
investigate drug:131I-acitretide injection
Sponsors
307th Hospital of Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Enrolled subject will be eligible to join this study only when he/she meets all the following criterias: 1. Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor; 2. Serum CEA increased (higher than the upper limit of laboratory normal range); 3. Full understanding of this study and voluntary signing of informed consent; 4. At least one measurable or assessable tumor lesion according to RECIST version 1.1 5. ECOG score = 50% (echocardiography); 9. Complete the following tests within 2 weeks prior to enrollment: 1) blood routine examination (14 days without blood transfusion): haemoglobin (HB) >= 90g/L; white blood cell count >= 3.0*10E9/L, neutrophil absolute value (ANC) >= 1.5*10^9/L; platelet (PLT) >=100 *10^9/L. 2) blood biochemical examination to meet the following criteria: total bilirubin (TBIL) = 60ml/min. 3) normal thyroid function (T3, T4, TSH in the normal range); 10. Women of childbearing age should agree that contraceptive measures (such as intrauterine devices, birth control pills or condoms) must be used within the study period and within 6 months after the end of the study; serum or urine pregnancy test negative for 7 days prior to study and must be non-lactating patients; men should agree to patients who have contraindications during the study period and within six months after the end of the study period.
Exclusion criteria
Exclusion criteria: Enrolled subject will be NOT eligible to join this study if he/she meets any of the following criterias: 1. Allergy to iodine; 2. Subjects with any severe and / or uncontrolled disease, including: 1) Subjects with poor blood pressure control (systolic blood pressure> 150 mmHg, diastolic blood pressure> 90 mmHg) 2) Myocardial ischemic or myocardial infarction, arrhythmia (including QT interval =4040ms) and = 2 levels of congestive heart failure (NYHA classification) 3) Active or uncontrollable serious infection (CTC AE 4.03 grade 2); 4) Liver cirrhosis, decompensated liver disease, active hepatitis (hepatitis B surface antigen, hepatitis C antibody positive) or chronic hepatitis need to receive antiviral therapy; 5) Renal failure requires hemodialysis or peritoneal dialysis; 6) Have a history of immunodeficiency, including HIV-positive or other acquired, congenital immune deficiency disease, or a history of organ transplantation; 7) With poor control of diabetes [fasting blood glucose (FBG)> 10mmol / L]; 8) With a history of or present duodenal ulcer, ulcerative colitis and other gastrointestinal diseases, combined with complete or incomplete intestinal obstruction or the researchers to determine the cause of gastrointestinal bleeding or perforation of other conditions; 9) Subjects with seizures and need treatment. 3. Any part of the radical radiotherapy, or red bone marrow exposure range of more than 25%; 4. Drug resistance (ADA) positive; 5. Subjects with bone metastases that cause severe bone pain symptoms requiring local radiotherapy; 6. Presence of brain, meningeal, spinal cord primary or metastatic tumor; 7. Pregnant women and lactating women and women of childbearing age before entering the test to detect HCG positive; 8. Subject used or is using the other experimental drugs with four weeks prior to participating this study; 9. The investigators consider it inappropriate to participate in this trial; 10. The subject is suffering from mental illness and can not follow the protocol; 11. Subjects who have previously used other monoclonal antibodies like CEA-conjugated iodine 131; 12. Partial prothrombin time and / or INR and prothrombin time is 1.5 times higher than the upper limit of normal (except for Subjects receiving anticoagulation); 13. There is a large number of pleural or ascites associated with clinical symptoms requiring continuous drainage.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD; | — |
Countries
China
Contacts
Public ContactWeiwei Yang
Shanghai Haikang Pharmaceutical Technology & Development Co. Ltd
Outcome results
None listed