WithdrawnPhase 2

Neoadjuvant Tremelimumab and Durvalumab With Gem/Cis in Intrahepatic Cholangiocarcinoma

Stopped: Sponsor decision and challenges in finding eligible participants

0Started 2024-12

Plain-language summary

The goal of this clinical trial is to test feasibility and safety of the combination of tremelimumab and durvalumab plus gemcitabine and cisplatin as a neoadjuvant treatment bridge patients to a curative resection in treatment naïve borderline resectable, or resectable with high risk for recurrence intrahepatic cholangiocarcinoma patients. The main question\[s\] it aims to answer are: * What is the rate of conversion of unresectable tumor to resectable cancer? * What are the side effects of this treatment combination? Participants will undergo an initial tumor biopsy, imaging and laboratory studies prior to starting treatment with durvalumab, tremelimumab, gemcitabine and cisplatin. Participants will continue for 4 cycles and if the tumor is found to be resectable then they will undergo surgical resection. If the tumor is unresectable (can't be surgically removed) after 4 cycles, then participants will receive 4 more cycles and repeated imaging. If the tumor remains unresectable then the participant will be treated with capecitabine for up to 8 cycles and durvalumab for up to 12 months.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients of age 18 years and older at the time of study entry, both sexes, all ethnicities.
✓. Patients with histologically proven intrahepatic cholangiocarcinoma, untreated with systemic therapy.
✓. Patients with an absence of extrahepatic metastasis (outside of periportal lymph node enlargement) or peritoneal carcinomatosis as demonstrated by CT-scan.
✓. Patients with a performance status ECOG 0, 1.
✓. Patients with an estimated life expectancy \> 6 months.
✓. Patients with disease that is not readily suitable for resection with curative intent, as validated by a multidisciplinary committee with at least one hepatobiliary surgeon, defined as stage II and stage III disease, surgical resectable if there is tumor shrinkage.
✓. Patients with at least one measurable lesion according to RECIST 1.1 criteria. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to start of study.
✓. Patients with platelets ≥ 75,000/mm3, polynuclear neutrophils ≥ 1500/mm3, hemoglobin ≥ 9g/dL.

Exclusion criteria

What they're measuring

Rate of Conversion from unresectable to resectable

Timeframe: 8 Cycles, 21 day cycles

Incidence of related treatment emergent adverse events

Timeframe: 36 months

Trial details

NCT IDNCT06017297

SponsorGeorgetown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Borderline Resectable Carcinoma trials