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NCT04511793
Hepatic Artery Infusion (HAI) Program at Duke University
NA trial testing Medtronic Synchromed II pump in Metastatic Colon Cancer. Withdrawn.
30 June 2022
Quick facts
| Lead sponsor | Michael Lidsky, M.D. |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 11 December 2020 |
| Primary completion | 30 June 2022 |
| Estimated completion | 31 December 2022 |
Drugs / interventions tested
- Medtronic Synchromed II pump
Conditions studied
- Metastatic Colon Cancer — all drugs for Metastatic Colon Cancer →
- Liver Cancer — all drugs for Liver Cancer →
- Intrahepatic Cholangiocarcinoma — all drugs for Intrahepatic Cholangiocarcinoma →
Sponsor
Michael Lidsky, M.D.
Who can join
Adults 18 to 80, any sex, with Metastatic Colon Cancer or Liver Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Duke HAI program was implemented in November 2018 and treated 30 patients in its first 17 months using the Medtronic Synchromed II device (only commercially available device suitable for HAI for cancer patients). The Duke HAI program has demonstrated safety of HAI with an overall complication rate was 19%, similar to prior published data, with all but one complication (extrahepatic perfusion) salvaged. The Investigator has also demonstrated feasibility and efficacy of a new HAI program, with 95% of patients initiating therapy with promising hepatic response and disease control rates. This protocol will enable the team to continue this program. All eligible patients will receive the synchromed II pump with a Codman catheter and chemotherapy including FUDR, dexamethasone and heparin. Systemic chemotherapy will be given per standard of care.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04511793
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Metastatic Colon Cancer
Currently open trials in the same condition.
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- NCT05848739 — A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors · Phase 1 · recruiting
- NCT05714124 — Liver Embolization Approaches for Tumor Management · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04511793 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Michael Lidsky, M.D.
- Last refreshed: 19 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04511793.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing