Bortezomib in Intrahepatic Cholangiocellular Carcinoma

STATUS

Recruiting
End date

Dec 21, 2022
participants needed

50
sponsor

Zhengang Yuan

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Updated on 25 February 2022

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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 Identifier	NCT03345303
Sponsor	Zhengang Yuan
Last Modified on	25 February 2022

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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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Bortezomib in Intrahepatic Cholangiocellular Carcinoma