Cancer cachexia
Conditions
Interventions
Intervention Group:Tocilizumab Injection Combined with Best Supportive Care
Sponsors
Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age: >=18 years old, gender is not limited; 2. Histologically or cytologically confirmed primary or postoperative recurrence of advanced solid tumors (mainly non-small cell lung cancer); 3. Weight loss >5% within 6 months without dieting; or BMI 2%; or limb skeletal muscle index meeting criteria for sarcopenia and any degree of weight loss >2%; 4. Inflammation: CRP > 30 mg/L and serum IL-6 > 2 times the upper limit of normal (2 x ULN) when infection is excluded; 5. ECOG PS score of 1-4; 6. No anti-cachexia or appetite stimulant medications (megestrol acetate, alamorelin, cyproheptadine, olanzapine, etc.) within 4 weeks prior to the first dose; 7. Subjects voluntarily enrolled in the study, signed an informed consent form, had good compliance, and cooperated with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Anti-IL-6 or anti-IL-6R therapy within 3 months prior to the start of treatment; 2. Patients unable to eat normally due to structural disorders of the gastrointestinal tract or non-tumor factors secondary to malignant disease (e.g. thrush, HIV infection, chronic kidney disease, etc.); 3. Participation in a clinical trial of another drug within 4 weeks prior to study entry; 4. Known to have serious adverse reactions and allergies to the drugs used in this group; 5. Patients with histologically or cytologically confirmed diagnosis of malignant tumors of bone marrow origin; 6. Patients with abnormal bone marrow function or abnormal hepatic or renal function confirmed by laboratory tests prior to the first use of the drug: (1) Neutrophil count (ANC) 1.5 times upper limit of normal (ULN) or creatinine clearance 1.5 times the upper limit of normal (ULN); (5) Glutamine aminotransferase (AST) or alanine aminotransferase (ALT) levels > 3 times the upper limit of normal (ULN); 7. Positive HIV test result; 8. Patients with active hepatitis B or C. Active hepatitis B is defined as a known (including screening) positive HBsAg result and a screening HBV-DNA quantification of >=1000 copies/mL. Active hepatitis C is defined as a known (including screening) positive HCV-Ab result and a screening HCV RNA quantification above the lower limit of detection; 9. A clear history of active tuberculosis; 10. Major surgery (excluding diagnostic surgery) within 4 weeks prior to the start of treatment; 11. Systemic corticosteroid medication, defined as a dose >10 mg/day prednisone or equivalent, within 4 weeks prior to the first dose (inhaled, topical, intraocular, intranasal, and intra-articular glucocorticoid injections need not be excluded); 12. Significant abnormalities in thyroid function (patients with hypothyroidism stabilized by hormone replacement therapy need not be excluded); 13. Pregnant or breastfeeding female patients, female patients of childbearing potential with a positive baseline pregnancy test, or patients of childbearing age who are unwilling to use effective contraception throughout the trial period; 14. Patients with a history of psychotropic substance abuse that cannot be abstained from or those with a history of psychiatric disorders; 15. Other severe, acute or chronic medical or psychiatric illness or laboratory abnormality that, in the investigator's opinion, may increase the risks associated with participation in the study or may interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cachexia response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the modified Glasgow Prognostic Score (mGPS);Change in the modified Glasgow Prognostic Score (mGPS);Change in weight and body composition;Change in anorexia-related symptoms;Change in fatigue-related symptoms;Change in handgrip strength;Change in high-sensitivity C-reactive protein (hs-CRP) and serum albumin levels;Comprehensive Metrics of Antitumor Treatment Delivery and Tolerability;Overall survival (OS) and the 6-month survival rate;Safety-related endpoints;Quality of Life (QoL) Questionnaire; | — |
Countries
China
Contacts
Public ContactLi Zhang
Peking Union Medical College Hospital
Outcome results
None listed