Clinical trial · Interventional
Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol
Phase II Study of RAD001 in Advanced Cholangiocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a clinical trial investigating the effectiveness and safety of the study drug RAD001 in patients with advanced (metastatic) cholangiocarcinoma. Palliative chemotherapy provides some benefit to this group of patients. However, chemotherapy treatment only shows low rates of radiological response and short times to tumour progression. Therefore, further treatment options are urgently required. In laboratory studies, RAD001 has been shown to interrupt the signals that cancer cells use to grow, spread and form new blood vessels (angiogenesis). RAD001 has been approved for the treatment of kidney cancer. It has also been approved for use in Australia for the treatment of patients with kidney and liver transplants, and has been used in thousands of patients worldwide for this indication. Preliminary studies suggest that RAD001 may have activity in a range of other cancers. This study will evaluate the activity of RAD001 in advanced cholangiocarcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAD001 | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAD001 10mg/d
- interventionNames
- Drug: RAD001
Primary outcomes (1)
- measure
- Tumour control
- timeFrame
- 12 weeks
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- 2 years
- measure
- Toxicity
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically/cytologically confirmed adenocarcinoma of gall bladder, intra or extra-hepatic biliary tract 2. Metastatic or locally advanced (unresectable) disease 3. Adequate organ function; creatinine\<1.5xULN, BR\<1.5xULN Neut\>1.5, Pts\>100 4. WHO Performance status 0-2 5. No prior chemotherapy for advanced Cholangiocarcinoma (Prior adjuvant chemotherapy is accepted) 6. Measurable or non-measurable disease 7. Informed consent for study participation and donation of tumour tissue for evaluation of relevant translational endpoints Exclusion Criteria: 1. Cytotoxic chemotherapy or immunotherapy within 4 weeks prior to enrolment 2. Prior therapy with mTOR inhibitors (sirolimus, temsirolimus, everolimus) 3. Known intolerance or hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) 4. Uncontrolled diabetes mellitus or hyperlipidaemia 5. Patients who have any severe and/or uncontrolled medical conditions 6. Active or uncontrolled severe infection 7. Cirrhosis, chronic active hepatitis or chronic persistent hepatitis 8. Severely impaired lung function 9. Patients with a known history of HIV seropositivity 10. Patients who have a history of another primary malignancy (Exceptions include non-melanoma skin cancer, carcinoma in situ of uterine cervix, or any other cancer treated with curative intent without evidence of relapse for more than 2 years) 11. Female patients who are pregnant or nursing (lactating), or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes
References
Publications (0)
Data not yet available