Bortezomib in Intrahepatic Cholangiocellular Carcinoma
Primary Purpose
Intrahepatic Cholangiocarcinoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Intrahepatic Cholangiocarcinoma focused on measuring Bortezomib
Eligibility Criteria
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.
Sites / Locations
- Easter hepatobiliary surgery hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Bortezomib treatment
supportive care
Arm Description
'Bortezomib Injectable Solution
supportive care
Outcomes
Primary Outcome Measures
Objective response rate
Objective response rate include response from stable disease to complete response based on RECIST 1.1
Secondary Outcome Measures
changes of platelet count
changes of platelet count after injection of Bortezomib
occurrence of peripheral neuritis
occurrence of any feeling of numbness of limbs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03345303
Brief Title
Bortezomib in Intrahepatic Cholangiocellular Carcinoma
Official Title
Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhengang Yuan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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 half will receive best supporting care.
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 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
Keywords
Bortezomib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bortezomib treatment
Arm Type
Experimental
Arm Description
'Bortezomib Injectable Solution
Arm Title
supportive care
Arm Type
No Intervention
Arm Description
supportive care
Intervention Type
Drug
Intervention Name(s)
Bortezomib
Other Intervention Name(s)
velcade
Intervention Description
Bortezomib Injectable Solution
Primary Outcome Measure Information:
Title
Objective response rate
Description
Objective response rate include response from stable disease to complete response based on RECIST 1.1
Time Frame
at least 2 months
Secondary Outcome Measure Information:
Title
changes of platelet count
Description
changes of platelet count after injection of Bortezomib
Time Frame
7 days
Title
occurrence of peripheral neuritis
Description
occurrence of any feeling of numbness of limbs
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yexiong Tan, Ph.D
Phone
00862181875362
Email
yxtan1214@163.COM
Facility Information:
Facility Name
Easter hepatobiliary surgery hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Wu, Ph.D
Phone
00862181875018
Email
beizong999@sina.com
12. IPD Sharing Statement
Learn more about this trial
Bortezomib in Intrahepatic Cholangiocellular Carcinoma
We'll reach out to this number within 24 hrs