Cachexia
Conditions
Interventions
Intervention group:Tocilizumab: single dose of 6 mg/kg, administered by intravenous infusion, with a treatment cycle every 2 to 3 weeks
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age: >=18 years; no gender restriction; 2. Diagnosis: Histologically or cytologically confirmed advanced primary or post-surgical recurrent solid tumors (primarily NSCLC and SCLC). 3. Weight Loss: >=5% unintentional weight loss within the past 6 months without dietary restriction; or BMI 2%; or appendicular skeletal muscle index meeting sarcopenia criteria (male 2%; 4. Inflammation: Elevated hsCRP >30 mg/L and serum IL-6 above the ULN, in the absence of infection; 5. ECOG PS of 2-4; 6. Organ Function: Major organ function assessed by the investigator as insufficient to tolerate standard first-line therapy; 7. Prior Anti-Tumor Therapy: No systemic anti-tumor treatment (e.g., chemotherapy, targeted therapy, or immunotherapy) within 3 months before the first administration; 8. Prior Anti-Cachexia or Appetite-Stimulating Medication: No use of anti-cachexia or appetite-stimulating agents (e.g., megestrol acetate, anamorelin, cyproheptadine, olanzapine) within 4 weeks before the first administration; 9. Consent and Compliance: Voluntary participation, signed informed consent, good compliance, and willingness to complete follow-up.
Exclusion criteria
Exclusion criteria: 1.Receipt of anti-IL-6 or anti-IL-6R therapy within 3 months prior to treatment initiation; 2.Cachexia secondary to non-tumor factors (e.g., candidiasis, HIV, chronic kidney disease) or inability to eat due to structural gastrointestinal obstruction; 3.Participation in another clinical trial within 4 weeks prior to the study; 4.Known severe adverse reactions or allergies to the study drugs; 5.Histologically or cytologically confirmed bone marrow-derived malignancies; 6.Laboratory abnormalities prior to the first dose, including: ANC 1.5×ULN or creatinine clearance 1.5×ULN; AST/ALT > 3×ULN; 7.Positive HIV test; 8.Active hepatitis B (HBsAg+ with HBV-DNA >= 1,000 copies/mL) or hepatitis C (HCV-Ab+ with HCV RNA above the detection limit); 9.History of active tuberculosis; 10.Major surgery within 4 weeks prior to treatment (excluding diagnostic procedures); 11.Systemic corticosteroid use >10 mg/day prednisone or equivalent within 4 weeks (except for inhaled, topical, intraocular, intranasal, or intra-articular use); 12.Significant thyroid dysfunction (stable hypothyroidism under hormone replacement therapy is allowed); 13.Pregnancy, breastfeeding, positive baseline pregnancy test, or unwillingness to use effective contraception during the study; 14.History of substance abuse or mental disorders; 15.Any severe or uncontrolled medical, psychiatric, or laboratory condition that, in the investigator’s judgment, may increase study risk or interfere with results interpretation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival and modified glasgow score improvement at Week 16; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Glasgow prognostic score;Body weight and body composition;Anorexia-related symptoms;Fatigue-related symptoms;Handgrip strength;Hypersensitive C-reactive protein and serum albumin;Completion of anti-tumor treatment;Overall survival (OS) and 6-month survival;Safety-Related Endpoints; | — |
Countries
China
Contacts
Public ContactZhang Li
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Outcome results
None listed