Clinical Trials Logo

Clinical Trial Summary

This is a single-site, open-label continued access study/treatment protocol under a treatment IDE. In addition to treating patients, the primary objective of this study is to assess the safety of using the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR) drug for adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma. After successful implantation, the combined pump and catheter system will be evaluated using a nuclear scan in the postoperative period, which is standard procedure to confirm that the pump is functioning prior to HAI of FUDR. Monitoring for safety will include a record of residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is being used for chemotherapy infusion) to determine if the pump is still working and surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a pump or catheter problem. Patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04684862
Study type Interventional
Source Abramson Cancer Center at Penn Medicine
Contact Ronald DeMatteo, MD
Phone 215-662-7539
Email Ronald.DeMatteo@pennmedicine.upenn.edu
Status Recruiting
Phase N/A
Start date February 8, 2021
Completion date July 2029

See also
  Status Clinical Trial Phase
Recruiting NCT05678218 - Preoperative Evaluation of Lymph Nodes of Cholangiocarcinoma
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Completed NCT01938729 - Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma Phase 1
Completed NCT03230318 - Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma Phase 2
Recruiting NCT06239532 - HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Not yet recruiting NCT05535647 - Second Line Therapy for Advanced Intrahepatic Cholangiocarcinoma Phase 2
Not yet recruiting NCT05009953 - Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer Phase 2
Terminated NCT02254681 - Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC Phase 2
Active, not recruiting NCT01954745 - A Phase II Study of Cabozantinib (XL-184) Monotherapy in Patients With Advanced Cholangiocarcinoma After Progression on First or Second Line Systemic Therapy Phase 2
Completed NCT01347333 - Stereotactic Body Radiotherapy for Liver Tumors N/A
Active, not recruiting NCT04526106 - REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT05285358 - Pressurized Intraperitoneal Aerosolized Nab-Paclitaxel in Combination With Gemcitabine and Cisplatin for the Treatment of Biliary Tract Cancer Patients With Peritoneal Metastases Phase 1
Completed NCT03320980 - RALPPS in Patients With Hilar and Intrahepatic Cholangiocarcinoma N/A
Withdrawn NCT05019677 - GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC Phase 2
Withdrawn NCT03801499 - Lenvatinib for Unresectable Intrahepatic Cholangiocarcinoma Phase 2
Completed NCT05489692 - HAIC Plus Targeted Therapy and/or PD-1 Inhibitors for Unresectable Intrahepatic Cholangiocarcinoma
Recruiting NCT06101277 - Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG) N/A
Active, not recruiting NCT01917370 - VEGF Signaling Promotes Cell Growth and Metastasis in Intrahepatic Cholangiocarcinoma in a VEGF Receptor Mediated Pathway N/A
Withdrawn NCT01775280 - Response of Hepatic Tumors to Radioembolization Phase 2
Not yet recruiting NCT05342194 - Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study Phase 3