Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
NCT Number: NCT06184841
Patients with liver metastasis from esophagus squamous (ESC) are usually offered systemic therapy. However, for those with predominant liver disease or failure of system therapy, local liver management becomes an option. This prospective single center study aimed to evaluate the efficacy and adverse events of hepatic arterial infusion chemotherapy (HAIC) using percutaneous catheter placement techniques for liver metastases from esophagus squamous (ESC).
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Beijing, Beijing Municipality, 100142, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hepatic arterial chemoinfusion (HAIC) was used for interventional therapy with at least 2 cycles of hepatic arterial infusion. The intervention was started with sintilimab at the same time, 200mg each time, and the drug was repeated every 3 weeks.
Time frame: Up to 2 years
Defined as the proportion of patients with Adverse events (AEs), Treatment Emergent Adverse events (TEAEs), Treatment-related AEs (TRAEs), immune-related AEs (irAEs), adverse events of special interest (AESI) and Serious Adverse events (SAE), assessed by NCI CTCAE v5.0
Time frame: Up to 2 years
Defined as proportion of patients who have a best response of CR or PR of liver metastases
Time frame: Up to 2 years
Defined as proportion of patients who have a best response of CR or PR
Time frame: Up to 2 years
Defined as the time between the date of treatment start and objective tumor response
Time frame: Up to 2 years
Defined as the time from first response (CR or PR) to the date of initial objectively documented progression or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Defined as the time from the date of treatment start to disease progression, or death due to any cause, whichever occurs first.
Time frame: Up to 2 years
Defined as the time from the date of treatment start to the date of death
Peking University Cancer Hospital & Institute
Other
Hepatic Arterial Infusion Chemotherapy Combined Sintilimab for Predominant Liver Metastasis From Esophageal Squamous Cell Carcinoma- A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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