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Bortezomib in Intrahepatic Cholangiocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT03345303
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
Zhengang Yuan, Eastern Hepatobiliary Surgery Hospital

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
Intrahepatic Cholangiocarcinoma Drug: Bortezomib 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 Type : Interventional  (Clinical Trial)
Estimated 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 : January 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Bortezomib treatment
'Bortezomib Injectable Solution
Drug: Bortezomib
Bortezomib Injectable Solution
Other Name: velcade
No Intervention: supportive care
supportive care

Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 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 [ Time Frame: 7 days ]
    changes of platelet count after injection of Bortezomib

  2. occurrence of peripheral neuritis [ Time Frame: 7 days ]
    occurrence of any feeling of numbness of limbs

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345303

Contact: Yexiong Tan, Ph.D 00862181875362 yxtan1214@163.COM

China, Shanghai
Easter hepatobiliary surgery hospital Recruiting
Shanghai, Shanghai, China, 200438
Contact: Jie Wu, Ph.D    00862181875018    beizong999@sina.com   
Sponsors and Collaborators
Zhengang Yuan

Responsible Party: Zhengang Yuan, Director of Oncology Department, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT03345303     History of Changes
Other Study ID Numbers: EHBH-201708
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 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, Eastern Hepatobiliary Surgery Hospital:

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents