Trials / Recruiting
RecruitingNCT06341764
Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma
Neo-adjuvant Chemo and Immunotherapy with Durvalumab (MEDI4736) and Tremelimumab (MEDI1123) in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma: an Exploratory and Translational Study.
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- Sponsor
- National Cancer Institute, Naples · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery.
Detailed description
Multicenter, single arm, phase II study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Durvalumab 1120 mg | Durvalumab 1120 mg day 1 i.v |
| DRUG | Durvalumab 1500 mg | Durvalumab i.v. at 1500 mg once every 4 weeks |
| DRUG | Tremelimumab i.v. at 300 mg | Single dose |
| COMBINATION_PRODUCT | Cisplatin (CDDP) 25 mg/mq i.v | Four cycles |
| COMBINATION_PRODUCT | Gemcitabine (GEM) 1000 mg/mq i.v. | Days 1 and 8 every 21 days |
Timeline
- Start date
- 2023-09-01
- Primary completion
- 2025-09-01
- Completion
- 2025-09-01
- First posted
- 2024-04-02
- Last updated
- 2024-11-07
Locations
6 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT06341764. Inclusion in this directory is not an endorsement.