Twenty US-Based Clinical Trials of Note in CCA That Are Active and Recruiting

March 2025, Vol 6, No 1

Systemic Medical Therapy/Phase 2-3

Clinical trial recruitment and retention remain challenging in bringing innovative medicines to patients. In oncology, therapies continue to evolve, yet researchers are frequently faced with low trial participation, particularly among minority groups.

This new CCA News feature aims to provide an ongoing list of US-based clinical trials actively recruiting for clinicians to use in discussions with their patients to encourage enrollment. The highlighted trials are new to this issue. Clinical trial identifiers can be found on www.ClinicalTrials.gov.

  • Study of tinengotinib vs physician’s choice a treatment of subjects with FGFR-alterations in cholangiocarcinoma (FIRST-308): NCT05948475.
  • Neoadjuvant therapy of HAIC (GEMOX) combined with adebrelimab and lenvatinib for resectable intrahepatic cholangiocarcinoma with high-risk recurrence factors: NEO-ERA-01 study: NCT06208462.
  • Stage II-IIIa urothelial cancer randomizing pre- operative nivolumab with or without relatlimab (TURANDORELA): NCT06237920.
  • Sacituzumab govitecan for the treatment for patients with locally advanced, recurrent, or metastatic cholangiocarcinoma: NCT06178588.
  • An open-label, multicenter, phase 2a/2b clinical trial to evaluate the efficacy, safety and tolerability of VG161 as monotherapy and in combination with nivolumab for treatment of patients with hepatocellular carcinoma or intrahepatic cholangiocarcinoma: NCT05223816.
  • Rilvegostomig + chemotherapy as adjuvant therapy for biliary tract cancer after resection (ARTEMIDE- Biliary01): NCT06109779.
  • Study of gemcitabine, cisplatin, AB680 and AB122 during first-line treatment of advanced biliary tract cancers (QUIC): NCT06048133.
  • Efficacy and safety of zanidatamab with standard-of- care therapy against standard-of-care therapy for advanced HER2-positive biliary tract cancer: NCT06282575.
  • Pembrolizumab with or without lenvatinib or chemotherapy in first-line treatment of advanced biliary tract cancer: NCT06230471.
  • Study of novel immunomodulators as monotherapy and in combination with anticancer agents in participants with advanced hepatobiliary cancer/biliary tract cancer: NCT05775159.
  • Lenvatinib, tislelizumab plus gemcitabine and cisplatin (GPLET) in patients with advanced cholangiocarcinoma: NCT05532059.
  • M9241 in combination with hepatic artery infusion pump (HAIP) and systemic therapy for subjects with metastatic colorectal cancer or intrahepatic cholangiocarcinoma: NCT05286814.
  • Gemcitabine and oxaliplatin chemotherapy with or without a floxuridine and dexamethasone pump in people with cholangiocarcinoma that cannot be removed with surgery: NCT04891289.
  • Precision medicine in patients with unresectable cholangiocarcinoma: radioembolization and combined biological therapy (PM-CARE): NCT06375915.
  • Gemcitabine + capecitabine vs capecitabine in curatively resected biliary tract cancer: NCT04401709.
  • NAPOLI-2: fluorouracil, leucovorin, and nanoliposomal irinotecan in biliary cancer: NCT04005339.
  • Olaparib in treating patients with metastatic biliary tract cancer with aberrant DNA repair gene mutations: NCT04042831.
  • Evaluating efficacy of tivozanib (AV-951) in biliary tract cancers: NCT04645160.
  • Durvalumab + intraductal radiofrequency ablation (ID-RFA) in extrahepatic cholangiocarcinoma: NCT06440993.
  • CTX-009 with gemcitabine, cisplatin, and durvalumab as first-line therapy in patients with unresectable or metastatic biliary tract cancers: NCT06548412.

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