Bortezomib in Intrahepatic Cholangiocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 21, 2022
  • participants needed
    50
  • sponsor
    Zhengang Yuan
Updated on 25 February 2022
measurable disease
oxaliplatin
gemcitabine
solid tumors
cholangiocarcinoma
cisplatin/gemcitabine

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.

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

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

Eligibility

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

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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.

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

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