Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2017-01-31
2022-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bortezomib treatment
'Bortezomib Injectable Solution
Bortezomib
Bortezomib Injectable Solution
supportive care
supportive care
No interventions assigned to this group
Interventions
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Bortezomib
Bortezomib Injectable Solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Have progressed after at least 2 cycles of systematic chemotherapy therapy（gemcitabine+cisplatin/gemcitabine+oxaliplatin）;
3. 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;
4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
5. Eastern Cooperative Oncology Group performance score (ECOG): 0-2; Life expectancy of at least 12 weeks;
6. Normal liver,kidney and bone marrow function；
7. Subjects who understand and voluntarily signed a written informed consent form.
Exclusion Criteria
2. There is any contraindication to use Bortezomib
3. 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).
4. 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.
5. Pregnant or lactating women.
6. History of radiation within 4 weeks prior to enrollment.
18 Years
75 Years
ALL
No
Sponsors
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Zhengang Yuan
OTHER
Responsible Party
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Zhengang Yuan
Director of Oncology Department
Locations
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Easter hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jie Wu, Ph.D
Role: primary
References
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Zeng TM, Jiang TY, Yang G, Cheng Z, Lou C, Wei W, Tao CJ, Hu S, Wang H, Cui XW, Tan YX, Dong LW, Wang HY, Yuan ZG. Bortezomib in previously treated phosphatase and tension homology-deficient patients with advanced intrahepatic cholangiocarcinoma: An open-label, prospective and single-centre phase II trial. Clin Transl Med. 2024 May;14(5):e1675. doi: 10.1002/ctm2.1675.
Other Identifiers
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EHBH-201708
Identifier Type: -
Identifier Source: org_study_id