CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative Chemotherapy Versus Immediate Resection in patIents With resecTable BiliarY Tract Cancers (BTC) at High Risk for Recurrence

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

November 7, 2023

Primary Completion Date

December 31, 2028

Study Completion Date

January 31, 2029

Conditions
Biliary Tract CancerCholangiocarcinoma
Interventions
DRUG

Gemcitabine

◦ Gemcitabine 800 mg/mq iv, day 1 and 8 of 21-day cycles, for 3 cycles

DRUG

Nab paclitaxel

◦ Nab-paclitaxel 100 mg/mq, day 1 and 8 of 21-day cycles, for 3 cycles

DRUG

Cisplatin

◦ Cisplatin 25 mg/mq iv, day 1 and 8 of 21-day cycles, for 3 cycles

PROCEDURE

Curative Surgery

Curative surgery on primary tumor

DRUG

Capecitabine

1250 mg/m2 given orally twice daily on days 1 to 14 of a 3 weekly cycle for a total of 8 cycles

Trial Locations (19)

20133

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

Unknown

NOT_YET_RECRUITING

Ospedali Riuniti di Ancona, Ancona

NOT_YET_RECRUITING

ASST Papa Giovanni XXIII, Bergamo

NOT_YET_RECRUITING

Oncologia Medica Policlinico Sant'Orsola - Malpighi, Bologna

NOT_YET_RECRUITING

ASST Spedali Civili, Brescia

NOT_YET_RECRUITING

Azienda Ospedaliera S. Croce e Carle, Cuneo

NOT_YET_RECRUITING

IRST Dino Amadori, Meldola

NOT_YET_RECRUITING

Humanitas Cancer Center, Milan

NOT_YET_RECRUITING

Ospedale Niguarda Cancer Center, Milan

NOT_YET_RECRUITING

Ospedale San Raffaele, Milan

NOT_YET_RECRUITING

Università di Modena, Modena

NOT_YET_RECRUITING

Ospedale S. Gerardo, Monza

NOT_YET_RECRUITING

IOV, Padua

NOT_YET_RECRUITING

Policlinico San Matteo, Pavia

RECRUITING

Azienda Ospedaliera Universitaria Pisa, Pisa

NOT_YET_RECRUITING

IRST (Cesena-Forlì-Meldola), Ravenna

NOT_YET_RECRUITING

Policlinico Gemelli, Rome

NOT_YET_RECRUITING

Azienda Ospedaliera Ordine Mauriziano, Turin

NOT_YET_RECRUITING

"AOUI Verona - Policlinico G.B. Rossi", Verona

All Listed Sponsors
lead

Gruppo Oncologico del Nord-Ovest

OTHER