After the standard first-line treatment, the treatment regimen was adjusted to a paclitaxel polymer micellar-based immunotherapy combination regimen
The subjects voluntarily participated in the study and agreed to sign the written informed consent, with good compliance and follow-up, and were at least 18 years old at the time of signing the informed consent, regardless of gender.
Patients with advanced biliary carcinoma diagnosed by imaging and histology as unresectable, recurrent, locally advanced, or with metastatic lesions are defined as stage IIIA or above according to the AJCC-8 staging system, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer. No more than 2 organs metastasized, including liver, lung, bone, and brain.
Radical surgery/local treatment, including focal excision, ablation, transcatheter arterial chemoembolization, hepatic arterial infusion chemotherapy, and radiotherapy, is not appropriate for at least 4 weeks prior to baseline assessment, or for disease progression thereafter. All acute toxic effects during local treatment must be ≤CTCAE5.0 grade 1.
Patients were intolerant or failed for ≥1 month after first-line systemic therapy, required palliative care, and patient adverse events were controlled (NCI-CTCAE≤ Grade I).
Those who have previously received treatment with immune checkpoint inhibitors, lenvatinib or paclitaxel, or are known to be allergic to or intolerant to immune checkpoint inhibitors, lenvatinib or paclitaxel and their components
Any systemic anti-tumor treatment received within the three months prior to participating in the study, including but not limited to intravenous infusion and/or oral chemotherapy, targeted drugs, antibody drugs and traditional Chinese medicines with known anti-cancer effects.
The patient is undergoing approved or under-development systemic anti-cancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or traditional Chinese medicine therapy with clear indications. Treatment is allowed 4 weeks before randomization.
The histopathological results show a mixture of liver cancer, squamous cell carcinoma or sarcoma cell components, or ampullary carcinoma.
Single group
Paclitaxel polymer micelle immunocombination
DrugPaclitaxel polymer micelle immunocombination
Objective response rate (ORR)
Proportion of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v1.1, assessed by investigators using contrast-enhanced abdominal CT or MRI (PET-CT may be supportive but not response-defining). Two consecutive scans ≥4 weeks apart are required to confirm response. Measure Type / Unit: Percentage of participants (%)
Adverse Events (AEs)
Incidence, nature, and severity of treatment-emergent adverse events graded per NCI CTCAE v5.0; includes serious AEs and AEs leading to dose modification or discontinuation.
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