Intrahepatic CholangiocarcinomaPhase 2NCT04479904

A Trial of Famitinib in Patients With Failure of First-Line Treatment For Intrahepatic Cholangiocarcinoma

A Phase 2 study testing Famitinib in people with Intrahepatic Cholangiocarcinoma, run by Jiangsu HengRui Medicine Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

This is a single-arm, open-label, multi-center Phase II clinical trial intended to observe and evaluate the efficacy and safety of famitinib malate in treating iCCA(Intrahepatic Cholangiocarcinoma ) patients with FGFR2 genetic aberrations who failed first-line therapy. 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?: Famitinib
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 10 Aug 2020to 10 Feb 2022
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntary participation and written informed consent;
Aged 18-75 years (inclusive), males and females;
Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy;
FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory;
At least one measurable lesion that has not been treated locally;
ECOG score of 0-1;
Expected survival ≥ 12 weeks;

Who cannot join

Presence of multiple factors affecting oral medications;
Wounds unhealed over a long period of time, or fractures not completely healed;
Known or suspected allergy to investigational drug or any drug related to this trial.
Known cases of CNS(Central Nervous System) metastasis;
Uncontrolled cardiac diseases or symptoms;
Patients with congenital or acquired immunodeficiency (such as HIV positive), or a history of organ transplants;
Patients previously treated with FGFR inhibitors (such as erdafitinib)

About this study

Official title: A Single-Arm, Open-Label, Multi-Center, Phase II Study of Famitinib Malate to Treat Intrahepatic Cholangiocarcinoma Patients With FGFR2(Fibroblast Growth Factor Receptor2) Genetic Aberrations Who Failed First-Line Therapy

Conditions: Intrahepatic Cholangiocarcinoma
Being tested: Famitinib
Medical subject headings: Cholangiocarcinoma

What participants receive

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

FamitinibDrug
po

Study groups in NCT04479904
Study group	Role	What they receive
famitinib	Experimental	Not described Receives: Drug: Famitinib

What is being measured

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

Objective response rate per RECIST 1.1
Measured: up to 24 months

Secondary outcomes (6)

DOR
Duration of Response
Measured: At pre-defined intervals from initial dose up to 24 months
DCR
Disease Control Rate
Measured: At pre-defined intervals from initial dose up to 24 months
PFS
Progression-Free-Survival
Measured: At pre-defined intervals from initial dose up to 24 months
OS
Overall survival
Measured: At pre-defined intervals from initial dose up to 24 months
Adverse events (AE) and serious adverse event (SAE)
Including incidence, grade (according to CTCAE V5.0 criteria), severity, duration, and causality with investigational drug
Measured: At pre-defined intervals from initial dose up to 24 months
Plasma concentrations of famitinib and its N-desethyl metabolite
Measured: At pre-defined intervals from initial dose up to 24 months

Timeline

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

10 Aug 202010 Feb 2022

First posted21 Jul 2020
Study start10 Aug 2020 (estimated)
Primary completion10 Dec 2021 (estimated)
Study completion10 Feb 2022 (estimated)

Why it stopped: It is difficult to screening subject

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 Jiangsu HengRui Medicine Co., Ltd.The 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: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04479904
Sponsor's protocol ID: SHR-1020-II-204
Status last verified: Jul 2020
First submitted: 17 Jul 2020
Last updated: 22 Jun 2021
Results posted: No
FDA-regulated drug: Yes
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?

Official record

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 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
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma

All Intrahepatic Cholangiocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Arm, Open-Label, Multi-Center, Phase II Study of Famitinib Malate to Treat Intrahepatic Cholangiocarcinoma Patients With FGFR2(Fibroblast Growth Factor Receptor2) Genetic Aberrations Who Failed First-Line Therapy
ClinicalTrials.gov ID: NCT04479904
Acronym / sponsor ID: SHR-1020-II-204
Conditions: Intrahepatic Cholangiocarcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: It is difficult to screening subject
Enrolment: 0 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 10 Aug 2020 (estimated)
Primary completion: 10 Dec 2021 (estimated)
Study completion: 10 Feb 2022 (estimated)
First posted: 21 Jul 2020 (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
famitinib	Experimental	Drug: Famitinib

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Voluntary participation and written informed consent;
Aged 18-75 years (inclusive), males and females;
Those with histopathologically diagnosed iCCA, who had previously undergone but failed first-line systematic chemotherapy;
FGFR2 fusion/rearrangement confirmed by tests conducted in designated central laboratory;
At least one measurable lesion that has not been treated locally;

Key exclusion criteria (7 listed)

Presence of multiple factors affecting oral medications;
Wounds unhealed over a long period of time, or fractures not completely healed;
Known or suspected allergy to investigational drug or any drug related to this trial.
Known cases of CNS(Central Nervous System) metastasis;
Uncontrolled cardiac diseases or symptoms;

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
Famitinibpo	Drug	famitinib

Primary outcome

Objective response rate per RECIST 1.1
Time frame: up to 24 months

6 secondary outcomes

DOR
Time frame: At pre-defined intervals from initial dose up to 24 months
DCR
Time frame: At pre-defined intervals from initial dose up to 24 months
PFS
Time frame: At pre-defined intervals from initial dose up to 24 months
OS
Time frame: At pre-defined intervals from initial dose up to 24 months
Adverse events (AE) and serious adverse event (SAE)
Time frame: At pre-defined intervals from initial dose up to 24 months
Plasma concentrations of famitinib and its N-desethyl metabolite
Time frame: At pre-defined intervals from initial dose up to 24 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.

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 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
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Famitinib in people with Intrahepatic Cholangiocarcinoma, run by Jiangsu HengRui Medicine Co., Ltd..

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 7 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: withdrawn, as of the sponsor's last update on 22 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Objective response rate per RECIST 1.1 (time frame: up to 24 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 NCT04479904.

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 22 Jun 2021; AzTrials last refreshed its copy on 8 Nov 2026.