RecruitingPhase 2NCT06341764

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.


Sponsor

National Cancer Institute, Naples

Enrollment

38 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests chemotherapy and immunotherapy given before surgery in patients with locally advanced cholangiocarcinoma — a cancer of the bile ducts inside or near the liver that is currently considered too difficult to operate on immediately. **You may be eligible if...** - You are over 18 years old with a confirmed bile duct cancer diagnosis - Your cancer is locally advanced but has been assessed in a multidisciplinary team meeting - You have not yet received any cancer treatment - You are in good general health (ECOG 0 or 1) with adequate blood, liver, and kidney function - Your weight is over 30 kg **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have serious heart, lung, or immune system problems - You have active hepatitis B, C, or HIV - You are pregnant or breastfeeding - You have had major surgery in the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab 1120 mg

Durvalumab 1120 mg day 1 i.v

DRUGDurvalumab 1500 mg

Durvalumab i.v. at 1500 mg once every 4 weeks

DRUGTremelimumab i.v. at 300 mg

Single dose

COMBINATION_PRODUCTCisplatin (CDDP) 25 mg/mq i.v

Four cycles

COMBINATION_PRODUCTGemcitabine (GEM) 1000 mg/mq i.v.

Days 1 and 8 every 21 days


Locations(6)

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

Naples, Italia, Italy

Ospedale Cardarelli, Napoli

Naples, Italia, Italy

Università di Napoli "Federico II", Napoli

Naples, Italia, Italy

Ospedale san Camillo Forlanini/Spallanzani, Roma

Roma, Italia, Italy

Ospedale Mauriziano, Umberto I°

Torino, Italia, Italy

Università di Verona, Ospedale Borgoroma, Verona

Verona, Italia, Italy

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NCT06341764


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