A Phase 2 interventional study of HAIC+TAE and Tislelizumab in Intrahepatic Cholangiocarcinoma, sponsored by Qilu Hospital of Shandong University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Qilu Hospital of Shandong University · Phase 2, Interventional, and Treatment
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.
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.
914 studies on the registry are indexed under Cholangiocarcinoma; 286 are open to participants now.
This study's enrollment of 28 is below the median of 50 across 687 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive hepatic arterial infusion chemotherapy (HAIC) sequential transcatheter arterial embolization(TAE) combined with Tislelizumab and Surufatinib
Drug: HAIC+TAE · Drug: Tislelizumab · Drug: Surufatinib
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.
Objective response rate (ORR)
the sum of complete response rate and partial response rate
Time frame: 24 months
Progression-free survival (PFS)
Time from randomization to disease progression
Time frame: 24 months
Conversion to surgical resection rate
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: 3 months
Overall survival (OS)
Time from randomization to death for any cause
Time frame: 24 months
1-year overall survival rate
one year overall survival rate
Time frame: 12 months
Disease Control rate (DCR)
the sum of complete response rate, partial response rate and stable disease rate
Time frame: 24 months
Incidence rate of adverse events
Defined as the proportion of patients with AE, treatment-related AE (TRAE), serious adverse event (SAE), assessed by NCI CTCAE v5.0
Time frame: 24 months
Plan to share: No
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This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Qilu Hospital of Shandong University