NCT06341764View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

September 1, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Cholangiocarcinoma
Interventions
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

Trial Locations (6)

10128

NOT_YET_RECRUITING

Ospedale Mauriziano, Umberto I°, Torino

37134

NOT_YET_RECRUITING

Università di Verona, Ospedale Borgoroma, Verona, Verona

80131

RECRUITING

Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale, Napoli

NOT_YET_RECRUITING

Ospedale Cardarelli, Napoli, Napoli

NOT_YET_RECRUITING

"Università di Napoli Federico II, Napoli", Napoli

00152

NOT_YET_RECRUITING

Ospedale san Camillo Forlanini/Spallanzani, Roma, Roma

All Listed Sponsors
lead

National Cancer Institute, Naples

OTHER