Bortezomib in Intrahepatic Cholangiocellular Carcinoma

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03345303
• Other study ID #: EHBH-201708
• Status: Recruiting
• Phase: Phase 3
• First received: November 6, 2017
• Last updated: November 15, 2017
• Start date: January 2017
• Est. completion date: December 2022

Study information

• Verified date: November 2017
• Source: Eastern Hepatobiliary Surgery Hospital
• Contact: Yexiong Tan, Ph.D
• Phone: 00862181875362
• Email: yxtan1214[@]163.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Drug:
• Bortezomib
Bortezomib Injectable Solution

Locations

Country	Name	City	State
China	Easter hepatobiliary surgery hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhengang Yuan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate	Objective response rate include response from stable disease to complete response based on RECIST 1.1	at least 2 months
Secondary	changes of platelet count	changes of platelet count after injection of Bortezomib	7 days
Secondary	occurrence of peripheral neuritis	occurrence of any feeling of numbness of limbs	7 days