OncoMatch/Clinical Trials/NCT05833815
Addition of Everolimus to Standard of Care in Carcinoma Gallbladder
Is NCT05833815 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2/3 trial studies multiple treatments including Everolimus 10 mg and Standard of care for gallbladder cancer.
Treatment: Everolimus 10 mg · Standard of care — Gallbladder cancer (GBC) is the most common malignant tumour of the biliary tract. It is also the most aggressive cancer of the biliary tract with the shortest median survival from the time of diagnosis. Currently, radical resection is the most effective strategy to potentially cure GBC. Chemotherapy and radiotherapy have been employed as adjuvant and palliative setting, however, the overall survival is still dismal. This study aim to evaluate the addition of Everolimus in addition to standard of care in gallbladder cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Cholangiocarcinoma
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: everolimus (everolimus)
Prior therapy with everolimus
Cannot have received: chemotherapy
Exception: adjuvant gemcitabine/capecitabine with or without platinum >= 6 months ago allowed
Chemotherapy <= 4 weeks prior to registration
Cannot have received: immunotherapy
Immunotherapy <= 4 weeks prior to registration
Cannot have received: biological therapy
Biological therapy <= 4 weeks prior to registration
Cannot have received: radiation therapy
Radiation therapy <= 4 weeks prior to registration
Cannot have received: radiation therapy to > 25% of bone marrow
Radiation to > 25% of bone marrow prior to registration
Lab requirements
Blood counts
ANC >= 1500/uL; Platelet >= 100,000/uL; Haemoglobin >= 8.0 g/dL
Kidney function
Creatinine <= 1.5 x Institutional ULN
Liver function
Total bilirubin <= 3mg/dl for gemcitabine and any value for Capecitabine; ALT and AST <= 2.5 x ULN (<= 5x ULN in patients with liver metastases); Alkaline phosphatase <= 5 x ULN
ANC >= 1500/uL; Platelet >= 100,000/uL; Total bilirubin <= 3mg/dl for gemcitabine and any value for Capecitabine; ALT and AST <= 2.5 x ULN (<= 5x ULN in patients with liver metastases); Creatinine <= 1.5 x Institutional ULN; Alkaline phosphatase <= 5 x Institutional ULN; Haemoglobin >= 8.0 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05833815 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior everolimus, chemotherapy, immunotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage III or IV is required.
Is there an age limit?
Yes. Patients must be 99 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages