Hepatocellular CarcinomaPhase 2NCT02946138
Phase II Trial of Carbon-ion Radiotherapy Combined With GM-CSF for the Treatment of Hepatocellular Carcinoma
A Phase 2 study testing carbon-ion radiotherapy in people with Hepatocellular Carcinoma, run by Shanghai Proton and Heavy Ion Center at 2 sites in China.
Trial summary
The aim of this research project is to assess the efficacy and toxicity of hypofractionated carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for the treatment of hepatocellular carcinoma Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- carbon-ion radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2016to Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis of HCC according to American association for the study of liver diseases （AASLD）-guidelines or clinical diagnosis criteria based on Alpha Fetoprotein （AFP), and radiological images proposed by Liver Cancer Society, Chinese Anti-Cancer Association;
- no clinically distant metastasis;
- the tumor is away from gastro-intestinal (GI) tract (>1cm);
- Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 10 cm;
- age ≥ 18 and <80 years of age;
- Karnofsky Performance Score ≥ 70;
- No previous invasive cancer (within 5 years before the HCC diagnosis)except for skin non-melanoma cancer or non muscle invasive bladder cancer; Ability to understand character and individual consequences of the clinical trial;
- Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;
Who cannot join
- Distant metastasis (M1);
- maximal tumor size is more than 10 cm;
- tumor invading adjacent gastrointestine (T4);
- Child push score B or C;
- Previous hepatic radiotherapy;
- Severe systemic disorders;
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- Previous malignancy (within 5 years) except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer;
- Non conformity of the radiotherapy dose distribution when compared to the dose constraints;
- Psychiatric disorders or any other condition that can make unreliable the informed consent;
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201321
Shanghai Proton and Heavy Ion Center
Shanghai, 201321
About this study
Official title: A Prospective Phase II Single-institution Trial of Carbon-ion Radiotherapy Combined With Granulocyte-macrophage Colony-stimulating Factor for the Treatment of Hepatocellular Carcinoma
The aim of this research project is to assess the efficacy and toxicity of hypofractionated carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for the treatment of hepatocellular carcinoma
Read the detailed description
Golden E.B. et al.in 2015 reported that localized radiotherapy granulocyte-macrophage colony-stimulating factor (GM-CSF) produced objective abscopal responses in solid tumor with metastasises. We hypothesize that hypofractionated carbon-ion radiotherapy combining granulocyte-macrophage colony-stimulating factor (GM-CSF) might improve the clinical response rate and progression-free survival (PFS) in hepatocellular carcinoma. The primary endpoint of the current phase II trial is progression-free survival rate at 2 years, secondary endpoints are overall survival, safety and toxicity.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- carbon-ion radiotherapy
- Keywords
- Hepatocellular Carcinoma, carbon-ion radiotherapy, GM-CSF, immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon-ion radiotherapyRadiation
Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions
| Study group | Role | What they receive |
|---|---|---|
| carbon-ion radiotherapy with GM-CSF | Experimental | Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gray(Gy) [relative biological effectiveness (RBE)] in 5 fractions for intrahepatic cases away from gastro-intestinal (GI) tract (>1cm) with concurrent GM-CSF 125ug/m2/d, subcutaneous injection d1-28; Receives: Radiation: carbon-ion radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival of all patients
Time in months measured from treatment initiation until the date of progression or the date of last follow-up.
Measured: 2 year
Secondary outcomes (3)
Overall Survival
Time in months measured from treatment initiation until the date of death or the date of last follow-up.
Measured: 2 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Time interval from the start of carbon-ion radiotherapy to 3 months after the completion of carbon-ion radiotherapy]
Objective responses rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2019
Why it stopped: enrollment was too slow
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guoliang Jiang, Shanghai Proton and Heavy Ion Center
- Investigators
- guo-liang jiang, Dr., Principal investigator, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946138
- Sponsor's protocol ID
- SPHIC-TR-HCC2016-02
- Status last verified
- Sep 2019
- First submitted
- 25 Oct 2016
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Single-institution Trial of Carbon-ion Radiotherapy Combined With Granulocyte-macrophage Colony-stimulating Factor for the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02946138
- Acronym / sponsor ID
- SPHIC-TR-HCC2016-02
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, carbon-ion radiotherapy, GM-CSF, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: enrollment was too slow
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (actual)
- First posted
- 27 Oct 2016 (estimated)
- 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 aim of this research project is to assess the efficacy and toxicity of hypofractionated carbon-ion radiotherapy with concurrent granulocyte-macrophage colony-stimulating factor for the treatment of hepatocellular carcinoma
Detailed description
Golden E.B. et al.in 2015 reported that localized radiotherapy granulocyte-macrophage colony-stimulating factor (GM-CSF) produced objective abscopal responses in solid tumor with metastasises. We hypothesize that hypofractionated carbon-ion radiotherapy combining granulocyte-macrophage colony-stimulating factor (GM-CSF) might improve the clinical response rate and progression-free survival (PFS) in hepatocellular carcinoma. The primary endpoint of the current phase II trial is progression-free survival rate at 2 years, secondary endpoints are overall survival, safety and toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carbon-ion radiotherapy with GM-CSF | Experimental | Radiation: carbon-ion radiotherapyHypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gray(Gy) [relative biological effectiveness (RBE)] in 5 fractions for intrahepatic cases away from gastro-intestinal (GI) tract (>1cm) with concurrent GM-CSF 125ug/m2/d, subcutaneous injection d1-28; |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- histologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis of HCC according to American association for the study of liver diseases （AASLD）-guidelines or clinical diagnosis criteria based on Alpha Fetoprotein （AFP), and radiological images proposed by Liver Cancer Society, Chinese Anti-Cancer Association;
- no clinically distant metastasis;
- the tumor is away from gastro-intestinal (GI) tract (>1cm);
- Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 10 cm;
- age ≥ 18 and <80 years of age;
Key exclusion criteria (9 listed)
- Distant metastasis (M1);
- maximal tumor size is more than 10 cm;
- tumor invading adjacent gastrointestine (T4);
- Child push score B or C;
- Previous hepatic radiotherapy;
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 |
|---|---|---|
| carbon-ion radiotherapyHypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions | Radiation | carbon-ion radiotherapy with GM-CSF |
Primary outcome
Progression-free survival of all patients
Time frame: 2 year
Time in months measured from treatment initiation until the date of progression or the date of last follow-up.
3 secondary outcomes
Overall Survival
Time frame: 2 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Time interval from the start of carbon-ion radiotherapy to 3 months after the completion of carbon-ion radiotherapy]
Objective responses rate
Time frame: 3 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 9 Sep 2019.
- Individual participant dataSharing planned: No
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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.
guo-liang jiang, Dr. principal investigator
Shanghai Proton and Heavy Ion Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carbon-ion radiotherapy in people with Hepatocellular Carcinoma, run by Shanghai Proton and Heavy Ion Center at 2 sites 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 9 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 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Progression-free survival of all patients (time frame: 2 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 9 Sep 2019.