Overview

Bortezomib in Intrahepatic Cholangiocellular Carcinoma

Status:
Recruiting

Trial end date:
2022-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Zhengang Yuan

Treatments:

Bortezomib

Criteria

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.