Bortezomib in Intrahepatic Cholangiocellular Carcinoma

Study Overview
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Brief Summary
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This study evaluates the efficacy and safety of second-line treatment of bortezomib in advanced intrahepatic cholangiocarcinoma patients.Half of participants will receive bortezomib while the other half will receive best supporting care.

Detailed Description
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There's no standard second-line treatment for advanced intrahepatic cholangiocarcinoma patients. Previous study indicated high mutation/deletion rate of PTEN gene in intrahepatic cholangiocarcinoma and poor prognosis of those patients with PTEN mutation/deletion. The investigators also found that the activity of proteasomes elevated in cholangiocarcinoma cells with PTEN mutation/deletion. So the investigators suppose proteasomes inhibitor could improve prognosis of intrahepatic cholangiocarcinoma patients with PTEN mutation/deletion

Official Title
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Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency

Conditions
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Intrahepatic Cholangiocarcinoma

Intervention / Treatment
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* Drug: Bortezomib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV; Have progressed after at least 2 cycles of systematic chemotherapy therapy（gemcitabine+cisplatin/gemcitabine+oxaliplatin）; The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment; Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1; Eastern Cooperative Oncology Group performance score (ECOG): 0-2; Life expectancy of at least 12 weeks; Normal liver,kidney and bone marrow function； Subjects who understand and voluntarily signed a written informed consent form. Exclusion Criteria: History of other malignancy within 3 years. Patients with central nervous system metastases or brain metastasis There is any contraindication to use Bortezomib Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction). A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence. Pregnant or lactating women. History of radiation within 4 weeks prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bortezomib treatment<br>'Bortezomib Injectable Solution | Drug: Bortezomib<br>* Bortezomib Injectable Solution<br>* Other names: velcade;|
| No Intervention: supportive care<br>supportive care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Objective response rate include response from stable disease to complete response based on RECIST 1.1 | at least 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of platelet count | changes of platelet count after injection of Bortezomib | 7 days | 
| occurrence of peripheral neuritis | occurrence of any feeling of numbness of limbs | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bortezomib