Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
NCT Number: NCT06239532
This is a single center, single arm, phase II, prospective study to evaluate the safety and effectiveness of HAIC combined with TAE plus an ICI and an TKI in adult patients (aged ≥18 years) with unresectable intrahepatic cholangiocarcinoma.
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Jinan, Shandong, 250012, China
Compared with systemic intravenous chemotherapy, hepatic arterial infusion chemotherapy(HAIC) has the advantages of increasing local drug concentration and reducing systemic toxic and side effects. All patients were treated with HAIC (Oxaliplatin and Raltitrexed ). Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time; Tislelizumab was given 200mg every 3 weeks. The treatment continued until the patient developed the disease or met the other criteria for terminating the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Procedure: HAIC+TAE After successful percutaneous hepatic artery cannulation for continuous pumping of drugs. Oxaliplatin(85 mg/m2); Raltitrexed (3 mg/m2) ,continuous infusion for 3 hours. HAIC was performed at an interval of at least 21 days.
Drug: Tislelizumab(200 mg) will be administered by IV infusion every 3 weeks
Drug: Surufatinib was taken orally after meals, once a day, with 3-5 capsules (50mg/capsule) each time.
Time frame: 24 months
the sum of complete response rate and partial response rate
Time frame: 24 months
Time from randomization to disease progression
Time frame: 3 months
Defined as the proportion of patients who were successfully converted to radical resection with negative hepatic margins after the study treatment regimen was calculated
Time frame: 24 months
Time from randomization to death for any cause
Time frame: 12 months
one year overall survival rate
Time frame: 24 months
the sum of complete response rate, partial response rate and stable disease rate
Time frame: 24 months
Defined as the proportion of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Qilu Hospital of Shandong University
Other
A Single-arm, Prospective Study of HAIC Sequential TAE Combined With Tislelizumab and Surufatinib in Unresectable Intrahepatic Cholangiocarcinoma
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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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