Intrahepatic CholangiocarcinomaPhase 2NCT03251443

A Study of Second-line Treatment With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

A Phase 2 study testing Apatinib in people with Intrahepatic Cholangiocarcinoma and Second-line Treatment, run by Peking Union Medical College Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Intrahepatic Cholangiocarcinoma, Second-line Treatment
What is being tested?: Apatinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteChina
Study dates: 8 Aug 2017to 8 May 2019
Phase: Phase 2
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 years and older
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 systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment;
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;
Subjects who understand and voluntarily signed a written informed consent form.

Who cannot join

Previous locoregional therapy within 4 weeks prior to enrollment.
Diagnosed with hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma.
Prepared for liver transplantation.
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.

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Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment.
Patients with central nervous system metastases or brain metastasis
Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia.
Pregnant or lactating women.
Patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: Single Center, Single Arm, Open Study, to Explore and Evaluate Treatment of Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

The purpose of this study is to explore the efficacy and safety of second-line treatment of apatinib in advanced intrahepatic cholangiocarcinoma patients and evaluate drug safety, progression free and overall survival. The primary endpoint of this study is objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).

Conditions: Intrahepatic Cholangiocarcinoma, Second-line Treatment
Being tested: Apatinib
Medical subject headings: Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApatinibDrug
Also called Apatinib mesylate tablets
500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.

Study groups in NCT03251443
Study group	Role	What they receive
Apatinib	Experimental	A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor. Receives: Drug: Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free Survival (PFS)
A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.
Measured: six months
Objective Response Rate (ORR)
Measured: one year
Disease Control Rate (DCR)
Measured: one year

Secondary outcomes (2)

Overall Survival (OS)
Overall survival (OS) was calculated from the date of initial treatment with apatinib to the date of death due to any cause
Measured: two years
Incidence of Treatment-Emergent Adverse Event
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 20178 May 2019

First posted16 Aug 2017
Study start8 Aug 2017
Primary completion8 Mar 2019
Study completion8 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Intrahepatic CholangiocarcinomaStudies of the same condition, open and under way.
More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03251443
Sponsor's protocol ID: JS-1392
Status last verified: Jul 2019
First submitted: 14 Aug 2017
Last updated: 2 Dec 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
RecruitingPhase 2
REGULUS: MRI-guided Adaptive SABR for Liver Cancers
Liver Cancer, Intrahepatic Cholangiocarcinoma

All Intrahepatic Cholangiocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Center, Single Arm, Open Study, to Explore and Evaluate Treatment of Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
ClinicalTrials.gov ID: NCT03251443
Acronym / sponsor ID: JS-1392
Conditions: Intrahepatic Cholangiocarcinoma, Second-line Treatment
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Peking Union Medical College HospitalUniversity, hospital or other
Collaborators: Jiangsu HengRui Medicine Co., Ltd.
Study start: 8 Aug 2017 (actual)
Primary completion: 8 Mar 2019 (actual)
Study completion: 8 May 2019 (actual)
First posted: 16 Aug 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Apatinib	Experimental	Drug: ApatinibA molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.

Who may qualify

Ages: 18 years and older
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 systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment;
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;

Key exclusion criteria (11 listed)

Previous locoregional therapy within 4 weeks prior to enrollment.
Diagnosed with hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma.
Prepared for liver transplantation.
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).

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
ApatinibAlso: Apatinib mesylate tablets500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.	Drug	Apatinib

Primary outcome

Progression-free Survival (PFS)
Time frame: six months
A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.
Objective Response Rate (ORR)
Time frame: one year
Disease Control Rate (DCR)
Time frame: one year

2 secondary outcomes

Overall Survival (OS)
Time frame: two years
Incidence of Treatment-Emergent Adverse Event
Time frame: one year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.

Related trials for Intrahepatic Cholangiocarcinoma

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Combination Therapy Using Durvalumab and Histotripsy for Treatment of Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma
RecruitingPhase 3
Efficacy and Safety of Zanidatamab With Standard-of-care Therapy Against Standard-of-care Therapy for Advanced HER2-positive Biliary Tract Cancer
Biliary Tract Cancer
RecruitingPhase 2
Perioperative Retlirafusp Alfa(Anti-PD-L1/TGF-β Bifunctional Fusion Protein) Plus Famitinib and GEMOX-Based Hepatic Arterial Infusion Chemotherapy for Locally Advanced Intrahepatic Cholangiocarcinoma: A Multicenter, Single-Arm, Exploratory Phase II Trial
Intrahepatic Cholangiocarcinoma (Icc), Neoadjuvant Therapy
RecruitingPhase 2
REGULUS: MRI-guided Adaptive SABR for Liver Cancers
Liver Cancer, Intrahepatic Cholangiocarcinoma

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.

Hai-tao Zhao study chair

Peking Union Medical College Hospital (PUMCH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib in people with Intrahepatic Cholangiocarcinoma and Second-line Treatment, run by Peking Union Medical College Hospital 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 11 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: finished, as of the sponsor's last update on 2 Dec 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: six months). The study lists 3 primary outcomes in all. 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 NCT03251443.

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 2 Dec 2020.