Intrahepatic CholangiocarcinomaPhase 3NCT03345303
Bortezomib in Intrahepatic Cholangiocellular Carcinoma
A Phase 3 study testing Bortezomib in people with Intrahepatic Cholangiocarcinoma, run by Zhengang Yuan at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intrahepatic Cholangiocarcinoma
- What is being tested?
- Bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Easter hepatobiliary surgery hospital
Shanghai, Shanghai Municipality, 200438
Jie Wu, Ph.D, 00862181875018, beizong999@sina.com
About this study
Official title: Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency
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.
Read the 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
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Bortezomib
- Keywords
- Bortezomib
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called velcade
Bortezomib Injectable Solution
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib treatment | Experimental | 'Bortezomib Injectable Solution Receives: Drug: Bortezomib |
| supportive care | No intervention | supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate include response from stable disease to complete response based on RECIST 1.1
Measured: at least 2 months
Secondary outcomes (2)
changes of platelet count
changes of platelet count after injection of Bortezomib
Measured: 7 days
occurrence of peripheral neuritis
occurrence of any feeling of numbness of limbs
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startJan 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengang Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhengang Yuan, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345303
- Sponsor's protocol ID
- EHBH-201708
- Status last verified
- Nov 2017
- First submitted
- 6 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38689424
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency
- ClinicalTrials.gov ID
- NCT03345303
- Acronym / sponsor ID
- EHBH-201708
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- Bortezomib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhengang YuanUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bortezomib treatment | Experimental | Drug: Bortezomib'Bortezomib Injectable Solution |
| supportive care | No intervention | –supportive care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BortezomibAlso: velcadeBortezomib Injectable Solution | Drug | Bortezomib treatment |
Primary outcome
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
2 secondary outcomes
changes of platelet count
Time frame: 7 days
occurrence of peripheral neuritis
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Derived from this study: PubMed 38689424Zeng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bortezomib in people with Intrahepatic Cholangiocarcinoma, run by Zhengang Yuan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yexiong Tan, Ph.D (00862181875362, yxtan1214@163.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: at least 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03345303, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.