Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370663
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-06
Brief Title:
First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma Combining Radiotherapy and HAIC
Sponsor:
Shandong Cancer Hospital and Institute
Organization:
Shandong Cancer Hospital and Institute
Study Overview
Official Title:
A Single-arm Exploratory Phase II Clinical Trial of Combined Radiotherapy and HAIC as First-line Treatment for Unresectable Locally Advanced Distal Cholangiocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The median survival of intrahepatic cholangiocarcinoma remains less than one year highlighting the need for new treatments Hepatic arterial infusion chemotherapy HAIC especially with fluoropyrimidine-based regimens has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma However clinical research on this combination is lacking as first-line therapy for unresectable ICC Therefore a single-center single-arm study aims to assess this treatment approachs safety efficacy and molecular predictors Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment In conclusion exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type
Detailed Description:
Intrahepatic cholangiocarcinoma ICC ranks as the second most common primary liver cancer constituting 15-20 of malignant liver tumors with a rising incidence trend Unlike hepatocellular carcinoma HCC ICC displays higher invasiveness and metastatic potential Surgical resection remains the optimal treatment yet many patients present with unresectable disease or metastasis limiting surgical options Chemotherapy particularly the GC regimen is standard for unresectable and metastatic ICC Studies like ABC-02 have improved survival with GC chemotherapy compared to gemcitabine monotherapy However the median survival remains less than one year highlighting the need for new treatments Hepatic arterial infusion chemotherapy HAIC especially with fluoropyrimidine-based regimens has shown promise in ICC treatment due to increased local drug concentration and reduced systemic toxicity A combined approach of radiotherapy and HAIC with gemcitabine infusion may offer a hopeful strategy for locally advanced cholangiocarcinoma However clinical research on this combination is lacking as first-line therapy for unresectable ICC Therefore a single-center single-arm study aims to assess this treatment approachs safety efficacy and molecular predictors Improved HAIC delivery through modified percutaneous implantation provides a reliable pathway for effective treatment In conclusion exploring the synergistic effects of radiotherapy and HAIC in ICC could pave the way for more effective and personalized treatment strategies for this challenging cancer type
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None