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Bortezomib in Intrahepatic Cholangiocellular Carcinoma

Sponsor
Zhengang Yuan (Other)
Overall Status
Recruiting
CT.gov ID
NCT03345303
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
71
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Bortezomib treatment

'Bortezomib Injectable Solution

Drug: Bortezomib
Bortezomib Injectable Solution
Other Names:
  • velcade

    		•
    No Intervention: supportive care

    supportive care

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate [at least 2 months]

      Objective response rate include response from stable disease to complete response based on RECIST 1.1

    Secondary Outcome Measures

    1. changes of platelet count [7 days]

      changes of platelet count after injection of Bortezomib

    2. occurrence of peripheral neuritis [7 days]

      occurrence of any feeling of numbness of limbs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;

    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:

    1. History of other malignancy within 3 years. Patients with central nervous system metastases or brain metastasis

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Easter hepatobiliary surgery hospital Shanghai Shanghai China 200438

    Sponsors and Collaborators

    • Zhengang Yuan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhengang Yuan, Director of Oncology Department, Eastern Hepatobiliary Surgery Hospital
    ClinicalTrials.gov Identifier:
    NCT03345303
    Other Study ID Numbers:
    • EHBH-201708
    First Posted:
    Nov 17, 2017
    Last Update Posted:
    Nov 17, 2017
    Last Verified:
    Nov 1, 2017
    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
    Keywords provided by Zhengang Yuan, Director of Oncology Department, Eastern Hepatobiliary Surgery Hospital
    Bortezomib
    Additional relevant MeSH terms:
    Cholangiocarcinoma
    Bortezomib

    Study Results

    No Results Posted as of Nov 17, 2017