Ampulla of Vater Carcinoma

P=N/A, N=420, Not yet recruiting, Alliance for Clinical Trials in Oncology

P2, N=54, Not yet recruiting, Yale University

Patients with advanced AC formed the "Descriptive cohort," while those treated with cisplatin-gemcitabine (CisGem) comprised the "CisGem-treated cohort." Among 534 trial participants, 28 (5.24%) had AC, and 17 received CisGem. Molecular profiling has revealed potentially actionable alterations, including HER2 amplification and KRAS mutations, supporting precision oncology approaches. This study provides the most comprehensive reference dataset to date for advanced AC treated with CisGem and emphasizes the importance of international collaboration and molecularly guided research to improve outcomes in this rare malignancy.

Compared with the absence of tracer uptake on 18F-FDG PET/CT, 18Ga-FAPI-04 PET/CT showed high tracer uptake and prominent tumor-to-background contrast. The final pathology confirmed an infiltrating adenocarcinoma, originating from the primary duodenal ampullary carcinoma.

P4, N=400, Recruiting, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Reduced survival rates were seen in populations with the TP53 or KRAS mutation. This study provides a detailed descriptive genomic landscape of ampullary carcinoma, highlighting frequent mutations between patient groups and the mutational burden of the DNA damage response pathway in ampullary cancer, laying important groundwork for the development of therapeutic targets and more individualized treatment regimens.

The PB subtype showed a higher pathological tumor stage than INT. Among the various schemas evaluated, the Harthimmer Integrated Liu Layered Scoring system performed best with a significant correlation between HE and IHC subtypes. INT subtypes had better prognostic outcomes than PB subtypes. We found an essential prognostic role of CDX2 in the stratification of ACs.

Histopathological examination of the biopsy specimen obtained before treatment initiation revealed intestinal-type ampullary cancer, and programmed cell death ligand 1 expression was positive in 10% of tumor cells and 5% of immune cells. Despite the limited evidence regarding the long-term efficacy of gemcitabine, cisplatin, and durvalumab therapy in ampullary cancer, this case report demonstrates its sustained effectiveness over 18 months in a patient with intestinal-type ampullary cancer.

P=N/A, N=360, Recruiting, Cedars-Sinai Medical Center | Trial completion date: Feb 2026 --> Jun 2026

Gastric-type adenomas are not uncommon among ampullary polyps when carefully examined. They should be distinguished from reactive polyps, because similar to intestinal-type adenomas, they are neoplastic polyps with dysplasia and a risk of recurrence.

P=N/A, N=300, Recruiting, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

P1/2, N=36, Recruiting, University Hospital, Lille | Trial completion date: Feb 2025 --> Feb 2030 | Trial primary completion date: Feb 2025 --> Feb 2028