refractory/advanced malignant solid tumors
Conditions
Interventions
single arm:fludarabine
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) The patient is well-informed of the current treatment options and the design of this trial; s/he is willing and able to give informed consent for participation in the study. (2) Aged 18-75 years. (3) Expected survival more than 6 months. (4) Diagnosis of refractory/advanced prostate cancer, pancreatic cancer, or colon cancer confirmed by histopathology or cytology. (5) Patients who have become refractory to first-line and second-line therapies in current clinical guidelines, and have disease progression measured by clinical or radiological examinations. (6) PLXNA1 amplification (>2 copy number) determined by Fluorescence In Situ Hybridization probes. (7) ECOG performance status 0-2.
Exclusion criteria
Exclusion criteria: (1) Patients who have previous exposure to any kind of targeted medications. (2) Patients who have received immunotherapy, including cancer vaccines, immune checkpoint inhibitors, etc. (3) Patients who have severe psychiatric disorders. (4) Patients complicated by severe cardiovascular diseases, including: a. congestive heart failure with NYHA class III/IV, b. cardiac infarction or received coronary artery bypass grafting surgery within 6 months at the time of recruitment, c. clinically significant ventricular dysrhythmias, or syncope of unknown origins, d. history of severe ischemic heart diseases, e. LVEF 2.5*ULN; CK >1*ULN; CK-MB >1*ULN; TnT >1.5*ULN; b. total serum bilirubin > 1.5*ULN; c. PT or APTT or INR > 1.5*ULN when anticoagulants are not taken or discontinued; d. hemoglobin <10g/dL; Platelet count < 100 x 10^9/L; Neutrophil count < 1.5 x 10^9/L. (7) Patients who have participated in other clinical trials or received any kind of gene therapy within the past 3 months. (8) Patients who, in the judgment of the investigators, are not suitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose (MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and Severity of Adverse Events;Objective Response Rate;Overall Survival;Progression-Free Survival;Cancer-Specific Survival;Quality of Life; | — |
Countries
China
Contacts
Public ContactShancheng Ren
Department of Urology, Shanghai Changhai Hospital.
Outcome results
None listed