NCT03345303

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2017

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

3.9 years

First QC Date

November 6, 2017

Last Update Submit

November 15, 2017

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

Bortezomib

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Objective response rate include response from stable disease to complete response based on RECIST 1.1

    at least 2 months

Secondary Outcomes (2)

  • changes of platelet count

    7 days

  • occurrence of peripheral neuritis

    7 days

Study Arms (2)

Bortezomib treatment

EXPERIMENTAL

'Bortezomib Injectable Solution

Drug: Bortezomib

supportive care

NO INTERVENTION

supportive care

Interventions

BortezomibDRUG

Bortezomib Injectable Solution

Also known as: velcade
Bortezomib treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;
  • Have progressed after at least 2 cycles of systematic chemotherapy therapy（gemcitabine+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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Easter hepatobiliary surgery hospital

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

Related Publications (1)

  • Zeng TM, Jiang TY, Yang G, Cheng Z, Lou C, Wei W, Tao CJ, Hu S, Wang H, Cui XW, Tan YX, Dong LW, Wang HY, Yuan ZG. Bortezomib in previously treated phosphatase and tension homology-deficient patients with advanced intrahepatic cholangiocarcinoma: An open-label, prospective and single-centre phase II trial. Clin Transl Med. 2024 May;14(5):e1675. doi: 10.1002/ctm2.1675.

    PMID: 38689424DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Yexiong Tan, Ph.D

CONTACT

00862181875362yxtan1214@163.COM

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Oncology Department

Study Record Dates

First Submitted

November 6, 2017

First Posted

November 17, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2022

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

CN(1)