Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma

Sponsor
National Cancer Institute, Naples
Study ID
NCT06341764
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab 1120 mg — DRUG
    Durvalumab 1120 mg day 1 i.v
  • Durvalumab 1500 mg — DRUG
    Durvalumab i.v. at 1500 mg once every 4 weeks
  • Tremelimumab i.v. at 300 mg — DRUG
    Single dose
  • Cisplatin (CDDP) 25 mg/mq i.v — COMBINATION_PRODUCT
    Four cycles
  • Gemcitabine (GEM) 1000 mg/mq i.v. — COMBINATION_PRODUCT
    Days 1 and 8 every 21 days

Study Details

Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery.

Key Dates

Start date
Sep 1, 2023
Status verified
Nov 2024
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm
    Patient will receive four cycles of cisplatin (CDDP) 25 mg/mq i.v. and gemcitabine (GEM) 1000 mg/mq i.v. days 1 and 8 every 21 days, plus durvalumab 1120 mg day 1, followed (one week after the last dose of CDDP/GEM) by two administrations of durvalumab i.v. at 1500 mg once every 4 weeks and one administration of tremelimumab i.v. at 300 mg single dose. Premedication with antihistamines at standard doses can be applied.

Primary Outcome Measure

Recurrence rate of CCA [ Time Frame: 24 months ]

Central Contacts

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