Intrahepatic CholangiocarcinomaPhase 2NCT03779100
Lenvatinib Plus PD-1 Antibody for Unresectable ICC
A Phase 2 study testing Lenvatinib and PD-1 antibody in people with Intrahepatic Cholangiocarcinoma, run by Shi Ming at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody for patients with unresectable intrahepatic cholangiocarcinoma. 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?
- Lenvatinib and PD-1 antibody
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 17 Dec 2018to 31 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of ICC
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- Chemotherapy resistance or patient refuse chemotherapy
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- Without distant metastasis, but intrahepatic lymph node metastasis is allowed
- The following laboratory parameters:
- Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Who cannot join
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Known central nervous system tumors including metastatic brain disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody for Unresectable Intrahepatic Cholangiocarcinoma
The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody for patients with unresectable intrahepatic cholangiocarcinoma.
- Conditions
- Intrahepatic Cholangiocarcinoma
- Being tested
- Lenvatinib, PD-1 antibody
- Keywords
- intrahepatic cholangiocarcinoma, Lenvatinib, PD-1 Antibody
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Also called E7080, Lenvima
12 mg (or 8 mg) once daily (QD) oral dosing.
PD-1 antibodyDrug
Also called Programmed cell death 1 antibody
3mg/kg intravenously every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib Plus PD-1 | Experimental | Participants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. Receives: Drug: Lenvatinib; Drug: PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
Measured: 12 months
Secondary outcomes (3)
Progression Free Survival (PFS)
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Measured: 12 months
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions.
Measured: 12 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start17 Dec 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: Protocol modification
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.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shi Ming
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779100
- Sponsor's protocol ID
- HCC-S075
- Status last verified
- Jan 2019
- First submitted
- 17 Dec 2018
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenvatinib Plus Programmed Cell Death Protein-1 (PD-1) Antibody for Unresectable Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT03779100
- Acronym / sponsor ID
- HCC-S075
- Conditions
- Intrahepatic Cholangiocarcinoma
- Keywords
- intrahepatic cholangiocarcinoma, Lenvatinib, PD-1 Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Protocol modification
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Shi MingUniversity, hospital or other
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Dec 2018 (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.
The purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with PD-1 antibody for patients with unresectable intrahepatic cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib Plus PD-1 | Experimental | Drug: Lenvatinib, Drug: PD-1 antibodyParticipants received lenvatinib capsules 12 milligram (mg) based on the participant's body weight greater than or equal to (>=) 60 kilogram (kg) or 8 mg based on the participant's body weight less than (<) 60 kg at baseline, orally, once daily (QD) in continuous 14-day treatment cycles, and received 3mg/kg PD-1 antibody intravenously every 2 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The diagnosis of ICC
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- Chemotherapy resistance or patient refuse chemotherapy
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
Key exclusion criteria (8 listed)
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
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 |
|---|---|---|
| LenvatinibAlso: E7080, Lenvima12 mg (or 8 mg) once daily (QD) oral dosing. | Drug | Lenvatinib Plus PD-1 |
| PD-1 antibodyAlso: Programmed cell death 1 antibody3mg/kg intravenously every 2 weeks | Drug | Lenvatinib Plus PD-1 |
Primary outcome
Overall survival (OS)
Time frame: 12 months
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: 12 months
Objective Response Rate (ORR)
Time frame: 12 months
Adverse Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lenvatinib and PD-1 antibody in people with Intrahepatic Cholangiocarcinoma, run by Shi Ming 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 8 inclusion and 8 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: paused, as of the sponsor's last update on 28 Jan 2019. 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?
Results are not available in the source record.
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?
Overall survival (OS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.