A Phase 2 interventional study of Adebrelimab and Lenvatinib in Biliary Tract Cancer, sponsored by Harbin Medical University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-29.
Sponsored by Harbin Medical University · Phase 2, Interventional, and Treatment
This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for borderline resectable, locally advanced biliary tract cancer.
This study plans to recruit 30 patients with borderline resectable, locally advanced biliary tract cancer who have not received treatment, abserve and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's planned enrollment of 30 is below the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →Harbin Medical University is the lead sponsor of 87 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib
Drug: Adebrelimab · Drug: Lenvatinib · Procedure: Hepatic Arterial Infusion Chemotherapy
Adebrelimab, IV
Also known as: SHR-1316
Lenvatinib, PO
Also known as: Lenvatinib Mesilate Capsules
GC regimen±5-FU
R0 resection rate
Postoperative staining results showed that the lesion was completely resected, and pathological biopsy of the transverse and longitudinal margins were negative.
Time frame: up to 24 months
Surgery conversion rate
Proportion of patients who can undergo surgical resection among all enrolled patients
Time frame: up to 24 months
Objective response rate
The proportion of patients whose tumor volume shrinks to a predetermined value and can maintain the minimum time limit, which is the sum of the proportions of complete remission and partial remission.
Time frame: up to 24 months
pathological complete response rate
After preoperative treatment and surgery, there are no residual viable tumor cells in the tumor bed in the postoperative specimen (%RVT=0)
Time frame: up to 24 months
Major pathological response rate
After preoperative treatment and surgery, the proportion of residual viable tumor cells in the tumor bed in the postoperative specimen is less than or equal to 10% (%RVT≤10)\*
Time frame: up to 24 months
Recurrence-free survival
Duration from surgical resection to first recurrence or death from any cause
Time frame: up to 24 months
Overall survival
Overall survival is measured from the first dose of study drug until death from any cause.
Time frame: up to 24 months
AEs
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Time frame: up to 24 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Harbin Medical University