Crizotinib-related diarrhea
Conditions
Interventions
Low dose group:Oral thalidomide 75mg
high does group:Oral thalidomide 150mg
Sponsors
Department of Oncology, The Second People's Hospital of Yibin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients with stage I-IV non-small cell lung cancer with ALK and ROS1 positive confirmed by pathology or cytology and genetic testing; (2) Patients with diarrhea during the targeted treatment of crizotinib should be judged by the investigator as crizotinib-associated diarrhea. (3) Postoperative: EC0G score 0-1, KPS score > 80; with tumor: ECOG score 0-3, KPS score > 50; (4) Survival is expected to be >6 months after surgery, with tumors >3 months; (5) Aged 18 to 75 years old male and female, no birth plan. (6) Blood routine WBC>=3.0x10^9/L, neutrophils>=1.5x10^9/L, hemoglobin>=70g/L, platelet>=75x10^9/L; all indexes of liver and kidney function are at the upper limit of normal value Within 2 times range; (7) The patient is receiving the molecular targeted drug crizotinib; it meets the diagnostic criteria for diarrhea, NCI-CTCAE4.0 evaluates >=1; the symptoms last for more than 1 day; there is no history of chronic diarrhea; (8) The patient signs the informed consent form, and the compliance is good, and the questionnaire can be completed by himself or with the help of others.
Exclusion criteria
Exclusion criteria: (1) Patients with non-small cell lung cancer who have not been diagnosed by pathology or cytology; (2) pregnant or lactating women; (3) patients with mental illness; patients with thrombosis; (4) There are serious, uncontrolled organic lesions or infections, such as decompensated heart, lung, kidney failure, etc., which can not tolerate drug treatment; (5) In other clinical trials; taking other antidiarrheal drugs at the same time; (6) Those who are allergic to research drugs; (7) Intestinal infectious diarrhea, diarrhea caused by acute poisoning, diarrhea caused by systemic diseases, dyspeptic diarrhea, amoebic dysentery, ulcerative colitis, Crohn's disease and other surgical acute abdomen, tumor disease itself Caused by diarrhea.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diarrhea relief rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence of diarrhea;Improvement of symptoms of gastrointestinal reactions;weight;Adverse reactions; | — |
Countries
China
Contacts
Public ContactJiaYuMing
Department of Oncology, The Second People's Hospital of Yibin
Outcome results
None listed