Status:
UNKNOWN
Bortezomib in Intrahepatic Cholangiocellular Carcinoma
Lead Sponsor:
Zhengang Yuan
Conditions:
Intrahepatic Cholangiocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 ha...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03345303
Start Date
January 1 2017
End Date
December 1 2022
Last Update
November 17 2017
Active Locations (1)
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1
Easter hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, China, 200438