Malignant solid tumor
Conditions
Interventions
ONE:Thalidomide Tablets 100 mg, taken orally, once a day, at least one hour after meals or before going to bed. After the researcher judges that there is a new RCCEP or the original RCCEP is increased
Sponsors
Chinese people's liberation army general hospital No.7 medical center
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age =18 years old. 2. Malignant solid tumor confirmed by histopathology or cytology. 3. After the regimen based on Camrelizumab, RCCEP with grade =G2 appears for the first time, and it is not necessary to suspend the continuous treatment of Camrelizumab, and it is not planned to use the treatment for RCCEP other than Thalidomide Tablets. 4. There are no adverse events of grade 3 or above (according to CTCAE version 5.0) except RCCEP (except for other toxicities such as hair loss that researchers think do not pose safety risks to patients). 5.ECOG PS score: 0-2. 6. The expected survival time is =3 months. 7. Can swallow pills normally. 8. Fertile women, including subjects with previous infertility history, must have a blood pregnancy test within 72 hours before the first drug administration and the result is negative; Female patients must agree to take reliable contraceptive measures at least 4 weeks before receiving thalidomide, during treatment and within 4 weeks after stopping taking it. Male patients must agree to use latex condoms when having any sexual contact with fertile women, including patients with previous infertility history, even if vasectomy has been performed. 9. With my consent and signed the informed consent form, I am willing and able to follow the planned visit, research and treatment, laboratory examination and other test procedures.
Exclusion criteria
Exclusion criteria: 1. It is known to be allergic to Thalidomide Tablets or auxiliary materials; 2. Late patients with symptoms, spread to internal organs, and risk of life-threatening complications in the short term; 3. Patients with interstitial pneumonia or interstitial lung disease, or with previous related medical history, or other subjects who may interfere with the judgment and treatment of immune-related pulmonary toxicity; 4. Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA=500 IU/mL), hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of the analysis method) or co-infection of hepatitis B and hepatitis C; 5. Active infection (CT CAE > grade 2), or unexplained fever > 38.5? and other signs of infection 2 weeks ago (except tumor-related fever), such as severe pneumonia, bacteremia and infection complications that require hospitalization, except preventive use of antibiotics; 6. Known history of alcohol dependence, psychotropic substance abuse or drug abuse; 7. Pregnant or lactating women; The fertile subjects are unwilling or unable to take effective contraceptive measures; 8. Plan to donate blood and sperm during taking Thalidomide Tablets and within 4 weeks after stopping taking it; 9. There are other abnormalities, which may increase the risk of participation, or interfere with the research results, as well as patients who the researchers think are not suitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-week RCCEP remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median remission time to RCCEP;6-week remission rate; | — |
Countries
China
Contacts
Public ContactXiaosong Li
Chinese people's liberation army general hospital No.7 medical center
Outcome results
None listed