Bortezomib in Intrahepatic Cholangiocellular Carcinoma

Overview

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.

Full Title of Study: “Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: December 2020

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

Interventions

  • Drug: Bortezomib
    • Bortezomib Injectable Solution

Arms, Groups and Cohorts

  • Experimental: Bortezomib treatment
    • ‘Bortezomib Injectable Solution
  • No Intervention: supportive care
    • supportive care

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • changes of platelet count
    • Time Frame: 7 days
    • changes of platelet count after injection of Bortezomib
  • occurrence of peripheral neuritis
    • Time Frame: 7 days
    • occurrence of any feeling of numbness of limbs

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhengang Yuan
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Zhengang Yuan, Director of Oncology Department – Eastern Hepatobiliary Surgery Hospital
  • Overall Contact(s)
    • Yexiong Tan, Ph.D, 00862181875362, yxtan1214@163.COM

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