Hepatocellular CarcinomaPhase 2NCT04169399
Toripalimab Plus Stereotactic Body Radiotherapy for HCC With PVTT
A Phase 2 study testing Toripalimab and Stereotactic body radiotherapy in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
To explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Toripalimab and Stereotactic body radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2019to 1 Jan 2021
- 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 HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria
- The normal liver volume in the non-target area was greater than 700ml
- Portal vein tumor thrumbus confirmed in two image techniques
- Eastern Cooperative Oncology Group performance status of 0 to 2
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
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- With no previous radiotherapy and immunotherapy
- Not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy.
- The following laboratory parameters:
- Platelet count ≥ 75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 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 Ability to understand the protocol and to agree to and sign a written informed consent document
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.
China1 site, 1 recruiting
- Recruiting
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, 510060
Ming Shi, MD, 8620-87343115, shiming@mail.sysu.edu.cn
About this study
Official title: Toripalimab Plus Stereotactic Body Radiotherapy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Single-arm, Prospective Trial
To explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus.
Read the detailed description
Programmed Cell Death Protein-1 (PD-1) was effective and tolerable in patients with advanced hepatocellular carcinoma. Additionally, previous studies showed that stereotactic body radiotherapy (SBRT) was effective for hepatocellular carcinoma with portal vein tumor thrombus (PVTT). No study has evaluated the efficacy and safety of toripalimab plus SBRT for hepatocellular carcinoma with PVTT. Thus, the investigators carried out this prospective study to find out it.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Toripalimab, Stereotactic body radiotherapy
- Keywords
- Hepatocellular carcinoma, Toripalimab, Stereotactic body radiotherapy, Portal vein tumor thrombus
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
240mg intravenously every 3 weeks
Stereotactic body radiotherapyRadiation
Radiotherapy dose was 36 ~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab plus SBRT | Experimental | Participants received 240mg toripalimab intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. Participants recevied Stereotactic body radiotherapy. Radiotherapy dose was 36 ~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks. Receives: Drug: Toripalimab; Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 iRECIST, or date of death, whichever occurred first
Measured: 6 months
Secondary outcomes (3)
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: 6 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 iRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.
Measured: 6 months
Adverse Events
Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start17 Nov 2019
- Primary completion17 Nov 2020 (estimated)
- Study completion1 Jan 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 Sun Yat-sen UniversityThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Ming, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169399
- Sponsor's protocol ID
- HCC-S1001
- Status last verified
- Nov 2019
- First submitted
- 17 Nov 2019
- Last updated
- 19 Nov 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 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Plus Stereotactic Body Radiotherapy for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Single-arm, Prospective Trial
- ClinicalTrials.gov ID
- NCT04169399
- Acronym / sponsor ID
- HCC-S1001
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Toripalimab, Stereotactic body radiotherapy, Portal vein tumor thrombus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 17 Nov 2019 (actual)
- Primary completion
- 17 Nov 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 19 Nov 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.
To explore the efficacy and safety of toripalimab plus stereotactic body radiotherapy for hepatocellular carcinom with portal vein tumor thrombus.
Detailed description
Programmed Cell Death Protein-1 (PD-1) was effective and tolerable in patients with advanced hepatocellular carcinoma. Additionally, previous studies showed that stereotactic body radiotherapy (SBRT) was effective for hepatocellular carcinoma with portal vein tumor thrombus (PVTT). No study has evaluated the efficacy and safety of toripalimab plus SBRT for hepatocellular carcinoma with PVTT. Thus, the investigators carried out this prospective study to find out it.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab plus SBRT | Experimental | Drug: Toripalimab, Radiation: Stereotactic body radiotherapyParticipants received 240mg toripalimab intravenously every 3 weeks up to documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent. Participants recevied Stereotactic body radiotherapy. Radiotherapy dose was 36 ~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria
- The normal liver volume in the non-target area was greater than 700ml
- Portal vein tumor thrumbus confirmed in two image techniques
- Eastern Cooperative Oncology Group performance status of 0 to 2
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 |
|---|---|---|
| Toripalimab240mg intravenously every 3 weeks | Drug | Toripalimab plus SBRT |
| Stereotactic body radiotherapyRadiotherapy dose was 36 ~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks. | Radiation | Toripalimab plus SBRT |
Primary outcome
Progression free survival (PFS)
Time frame: 6 months
PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on iRECIST, or date of death, whichever occurred first
3 secondary outcomes
Overall survival (OS)
Time frame: 6 months
Objective Response Rate (ORR)
Time frame: 6 months
Adverse Events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 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.
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 Toripalimab and Stereotactic body radiotherapy in people with Hepatocellular Carcinoma, run by Sun Yat-sen University 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 10 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: status not confirmed, as of the sponsor's last update on 19 Nov 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?
Contact Ming Shi, MD (+862087343938, shiming@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 6 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 19 Nov 2019.