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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAIC+Immune-targeted therapy | Experimental | Hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab, IV |
|
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| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Postoperative staining results showed that the lesion was completely resected, and pathological biopsy of the transverse and longitudinal margins were negative. | up to 24 months |
| Surgery conversion rate | Proportion of patients who can undergo surgical resection among all enrolled patients | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 24 months |
| pathological complete response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yubao Zhang, MD | Contact | +86 139 3658 8077 | zhyb88077@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yubao Zhang, MD | Harbin Medical University Affiliated Cancer Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| Lenvatinib | Drug | Lenvatinib, PO |
|
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| Hepatic Arterial Infusion Chemotherapy | Procedure | GC regimen±5-FU |
|
After preoperative treatment and surgery, there are no residual viable tumor cells in the tumor bed in the postoperative specimen (%RVT=0) |
| 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)* | up to 24 months |
| Recurrence-free survival | Duration from surgical resection to first recurrence or death from any cause | up to 24 months |
| Overall survival | Overall survival is measured from the first dose of study drug until death from any cause. | up to 24 months |
| AEs | Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. | up to 24 months |
| D004066 |
| Digestive System Diseases |