Bortezomib in Intrahepatic Cholangiocellular Carcinoma

  • End date
    Dec 21, 2022
  • participants needed
  • sponsor
    Zhengang Yuan
Updated on 25 February 2022
measurable disease
solid tumors


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.


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

Condition Intrahepatic Cholangiocarcinoma
Treatment Bortezomib
Clinical Study IdentifierNCT03345303
SponsorZhengang Yuan
Last Modified on25 February 2022


Yes No Not Sure

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 therapygemcitabine+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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note