Hepatocellular CarcinomaPhase 2NCT04042805
Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma
A Phase 2 study testing Sintilimab and Lenvatinib in people with Hepatocellular Carcinoma, run by Baocai Xing at 1 site in China.
Trial summary
This ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Sintilimab and Lenvatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 30 Aug 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease without any distant or lymphatic metastasis , or BCLC Stage B disease not amenable to curative surgery
- No previous systemic anticancer treatment or TACE treatment
- Age ≥18 years
- ECOG performance status: 0-1
- Child Pugh score≤7
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- Has at least one measurable hepatocellular carcinoma (HCC) lesion based on RECIST 1.1
- Life expectancy ≥12 weeks.
- Patients must be able to understand and willing to sign a written informed consent document
Who cannot join
- Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma
- History of hepatic encephalopathy or liver transplantation
- Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage.
- Untreated hepatitis infection: HBV DNA>2000IU/mlor10000 copy/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- History of symptomatic interstitial lung disease or other conditions that may cause confusion when discovering or managing suspicious drug-related lung toxicity
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- With serious systemic diseases such as heart disease and cerebrovascular disease, and the condition is unstable or uncontrollable.
- Evidence of active pulmonary tuberculosis (TB).
- Positive test of immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- History of allergic reactions to related drugs
- Pregnant women, nursing mothers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lijun Wang, Doctor, +8615801154770, wanglijun1017@163.com
Baocai Xing, Doctor
About this study
Official title: Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study
This ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local advanced hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Sintilimab, Lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SintilimabBiological
Also called IBI308
200mg intravenously every 3 weeks
LenvatinibDrug
12 mg (or 8 mg) once daily (QD) oral dosing.
| Study group | Role | What they receive |
|---|---|---|
| Sintilimab Plus Lenvatinib | Experimental | Participants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day (QD) plus sintilimab 200 mg intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. Receives: Biological: Sintilimab; Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: 1 year after the last patient's enrollment
Secondary outcomes (4)
Overall Survival
Measured: 2 years after the last patient's enrollment
Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs).
Measured: 2 years after the last patient's enrollment
Conversion rate to surgery
Conversion rate defined as the proportion of participants be able to receive surgery after the initiation of the study treatment
Measured: 1 year after the last patient's enrollment
Tumor mutation burden in association with ORR and survival.
It will be performed by NGS.
Measured: 1 year after the last patient's enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start1 Aug 2019
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baocai Xing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Baocai Xing, Peking University Cancer Hospital & Institute
- Investigators
- Baocai Xing, Doctor, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042805
- Sponsor's protocol ID
- 2019088
- Status last verified
- Feb 2021
- First submitted
- 30 Jul 2019
- Last updated
- 2 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined With Lenvatinib in Local Advanced Hepatocellular Carcinoma: A Single-arm, Open-label, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT04042805
- Acronym / sponsor ID
- 2019088
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Baocai XingUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 2 Aug 2019 (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 ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sintilimab Plus Lenvatinib | Experimental | Biological: Sintilimab, Drug: LenvatinibParticipants receive lenvatinib 12 mg (for participants with screening body weight ≥60 kg) or 8 mg (for participants with screening body weight <60 kg) orally once a day (QD) plus sintilimab 200 mg intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Has a diagnosis of hepatocellular carcinoma confirmed by radiology, histology, or cytology
- Barcelona Clinic Liver Cancer (BCLC) Stage C disease without any distant or lymphatic metastasis , or BCLC Stage B disease not amenable to curative surgery
- No previous systemic anticancer treatment or TACE treatment
- Age ≥18 years
- ECOG performance status: 0-1
Key exclusion criteria (11 listed)
- Fibrous lamina hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma
- History of hepatic encephalopathy or liver transplantation
- Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage.
- Untreated hepatitis infection: HBV DNA>2000IU/mlor10000 copy/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
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 |
|---|---|---|
| SintilimabAlso: IBI308200mg intravenously every 3 weeks | Biological | Sintilimab Plus Lenvatinib |
| Lenvatinib12 mg (or 8 mg) once daily (QD) oral dosing. | Drug | Sintilimab Plus Lenvatinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: 1 year after the last patient's enrollment
4 secondary outcomes
Overall Survival
Time frame: 2 years after the last patient's enrollment
Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs).
Time frame: 2 years after the last patient's enrollment
Conversion rate to surgery
Time frame: 1 year after the last patient's enrollment
Tumor mutation burden in association with ORR and survival.
Time frame: 1 year after the last patient's enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
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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.
Baocai Xing, Doctor principal investigator
Peking University Cancer Hospital & Institute
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 Sintilimab and Lenvatinib in people with Hepatocellular Carcinoma, run by Baocai Xing 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 9 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: status not confirmed, as of the sponsor's last update on 2 Mar 2021. 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?
Contact Baocai Xing, Doctor (+8613910721238, xingbaocai88@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 1 year after the last patient's enrollment). 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 2 Mar 2021.