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 approach's 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.
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 approach's 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Radiotherapy + Hepatic Arterial Infusion Chemotherapy (Gesitabine) + Chemotherapy (GEMOX)
Hepatic Arterial Infusion Chemotherapy (GEMOX)
Chemotherapy (Gesitabine)
Jinbo Yue
Jinan, Shandong, China
Adverse Events
Assessing the severity of adverse events according to CTCAE v4.0.3 standards.
Time frame: 2 year
Progression-Free Survival (PFS)
the length of time during and after treatment with a medication or therapy that a patient lives with the disease without it progressing
Time frame: 2 year
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