Hepatocellular CarcinomaPhase 1NCT04104074
Safety and Efficacy of Radiotherapy Plus Sintilimab for HCC With Portal Vein Tumor Thrombosis
A Phase 1 study testing Radiotherapy and Sintilimab in people with Hepatocellular Carcinoma and Portal Vein Tumor Thrombosis, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma, Portal Vein Tumor Thrombosis
- What is being tested?
- Radiotherapy and Sintilimab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2019to 31 Dec 2021
- Phase
- Phase 1
- 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
- Ability to understand and willingness to sign a written informed consent document.
- Locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches)
- Has at least 1 measurable lesion
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function
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- Child Pugh class A
- Life expectancy ≥12 weeks.
- Antiviral therapy per local standard of care for hepatitis B
- Woman of child bearing potential must have a negative pregnancy test
- Must use acceptable form of birth control while on study
Who cannot join
- Has previously been performed by raditotherapy for the area to be treated.
- With extrahepatic metastasis
- History of hepatic encephalopathy or liver transplantation
- Untreated hepatitis infection: HBV DNA>2000IU/mlor10000 copy/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive
- Has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes
- Has had esophageal or gastric variceal bleeding within 3 months prior to study enrollment
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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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Gong Li, MD, dr_gongli@163.com
About this study
Official title: A Pilot Study to Evaluate the Safety and Efficacy of Radiotherapy Plus Sintilimab for Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.
Read the detailed description
The patients were divided into two groups. The first group: the single dose of radiotherapy was 200 cGy, once a day, the total dose was 5000 cGy. The second group: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.
- Being tested
- Radiotherapy, Sintilimab
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Arm 1: The single radiotherapy dose was 200cGy, once a day, and the total dose was 5000cGy.
Arm 2: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.
SintilimabDrug
Also called IBI308
Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy Plus Sintilimab | Experimental | HCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment. Receives: Radiation: Radiotherapy; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Safety and tolerability of radiotherapy plus sintilimab based on NCI CTCAE v4.03 and RTOG/EORTC criteria
Measured: 1 year
Secondary outcomes (3)
Overall response rate (ORR)
Objective response rate based on RECIST v1.1 criteria
Measured: 1 year
Progression-free survival (PFS)
Measured: 2 years
Overall Survival (OS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start25 Nov 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Dec 2021 (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.
- More trials run by Beijing Tsinghua Chang Gung 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gong Li, MD, Principal investigator, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104074
- Sponsor's protocol ID
- 19048-0-01
- Status last verified
- Jul 2020
- First submitted
- 24 Sep 2019
- Last updated
- 7 Jul 2020
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Safety and Efficacy of Radiotherapy Plus Sintilimab for Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
- ClinicalTrials.gov ID
- NCT04104074
- Acronym / sponsor ID
- 19048-0-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Sep 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.
The proposed study is an open-label, single-center, single arm phase 1b study to evaluate the safety and efficacy of radiotherapy plus sintilimab for HCC with PVTT.
Detailed description
The patients were divided into two groups. The first group: the single dose of radiotherapy was 200 cGy, once a day, the total dose was 5000 cGy. The second group: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy Plus Sintilimab | Experimental | Radiation: Radiotherapy, Drug: SintilimabHCC Patients will be received radiotherapy and concurrent Sintilimab (PD-1 inhibitor)treatment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Locally advanced hepatocellular carcinoma with identified tumor thrombosis of main portal vein or primary branches (left and / or right branches)
- Has at least 1 measurable lesion
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key exclusion criteria (10 listed)
- Has previously been performed by raditotherapy for the area to be treated.
- With extrahepatic metastasis
- History of hepatic encephalopathy or liver transplantation
- Untreated hepatitis infection: HBV DNA>2000IU/mlor10000 copy/ml, HCV RNA> 1000copy/ml, both HbsAg and anti-HCV body are positive
- Has liver tumor not amenable to radiotherapy, or has had prior upper abdominal radiation therapy within planned volumes
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 |
|---|---|---|
| RadiotherapyArm 1: The single radiotherapy dose was 200cGy, once a day, and the total dose was 5000cGy. Arm 2: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy. | Radiation | Radiotherapy Plus Sintilimab |
| SintilimabAlso: IBI308Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks | Drug | Radiotherapy Plus Sintilimab |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 1 year
Safety and tolerability of radiotherapy plus sintilimab based on NCI CTCAE v4.03 and RTOG/EORTC criteria
3 secondary outcomes
Overall response rate (ORR)
Time frame: 1 year
Progression-free survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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.
Gong Li, MD principal investigator
Beijing Tsinghua Changgeng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiotherapy and Sintilimab in people with Hepatocellular Carcinoma and Portal Vein Tumor Thrombosis, run by Beijing Tsinghua Chang Gung 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 11 inclusion and 10 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 7 Jul 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Gong Li, MD (0086-10-56119427, dr_gongli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: 1 year). 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 7 Jul 2020.