advanced solid tumors
Conditions
Interventions
advanced solid tumors:Utidelon injection with continuous infusion for 120h
Sponsors
Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: (1)Pathologically diagnosed as advanced/metastatic solid tumor. (2)Standard treatment failure with indications for paclitaxel. (3)According to RECIST1.1, there is at least one measurable lesion. (4)Age = 18, regardless of gender. (5)ECOG 0-2 points (ZPS, 5-point method). (6)Expected survival time not less than 3 months. (7)No abnormalities in blood routine test 1 week before enrollment. Neutral Granulocyte absolute count (ANC) =1.5×109g/L, Platelet =80×109/L, hemoglobin =9g/dL. (8)There were no significant abnormalities in liver and kidney function one week before enrollment. Serum total bilirubin<1.5 times the normal upper limit, glutamine Enzyme (ALT)/aspartate aminotransferase (AST) =3 times the normal upper limit (no liver metastasis), or = 5 times the upper limit of normal value (liver metastasis). Serum creatinine=50mL/min. (9)Fertility capable subjects, including both males and females, are required to agree to use reliable contraceptive methods throughout the entire trial period and at least 3 months after the last medication. Pregnancy tests in the blood or urine of women of childbearing age must be negative when enrolled. (10)Willing and able to sign informed consent form.
Exclusion criteria
Exclusion criteria: (1)Received chemotherapy, radiation therapy, and other anti-tumor treatments within 4 weeks before enrollment. (2)Has undergone major organ surgery 4 weeks prior to enrollment or may undergo elective surgery during the trial period. (3)Peripheral neuropathy (NCI CTC 4.03) grade 2 or above. (4)Allergies to microtubule drugs or castor oil in the past. (5)Pregnancy (positive pregnancy test) or lactation. (6)Previous treatment adverse reactions have not recovered to (NCI CTC 4.03) level 1, except for those judged by the researchers to have no clinical safety risk. (7)Central metastasis determined by researchers as unsuitable for inclusion. (8)Active infection. (9)Have a history of immune deficiency related diseases, including HIV antibody positivity. (10)History of hepatitis or virus titer>ULN. (11)Have a serious history of cardiovascular and cerebrovascular diseases. (12)Mental disorders or poor compliance. (13)Researchers believe that having other serious medical histories is not suitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;Clinical Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life;PFS;DCR; | — |
Countries
China
Contacts
Public ContactLijun Ma
Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed