Hepatocellular CarcinomaNCT02802124
Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
A study testing carbon-ion radiotherapy for tumor away from GI and carbon-ion radiotherapy for tumor adjacent to GI in people with Hepatocellular Carcinoma, run by Shanghai Proton and Heavy Ion Center at 1 site in China.
Trial summary
The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese 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 for tumor away from GI and carbon-ion radiotherapy for tumor adjacent to GI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2015to Oct 2023
- Phase
- Interventional
- 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;
- Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 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 12 cm;
- tumor invading adjacent gastrointestine (T4);
- Child push score B or C;
- Previous hepatic radiotherapy;
- Severe systemic disorders;
Show all 9Show fewer
- 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
1 site in 1 country.
China1 site
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, 201321
About this study
Official title: Phase I Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese hepatocellular carcinoma
Read the detailed description
The purpose of this study is to determine the maximal tolerated dose (MTD) of carbon ion radiotherapy (CIRT) in the treatment of localized Chinese hepatocellular carcinoma with respective to toxicity and tumor control. Participants will be treated with CIRT with escalating dose regimens based on the tumor location to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 3 months after the completion of CIRT. Primary endpoint is toxicity, second endpoint is progression-free survival, overall survival and tumor response.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- carbon-ion radiotherapy for tumor away from GI, carbon-ion radiotherapy for tumor adjacent to GI
- Keywords
- hepatocellular carcinoma, carbon-ion radiotherapy, toxicity, efficacy
- 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 radiotherapy for tumor away from GIRadiation
carbon-ion radiotherapy for tumor adjacent to GIRadiation
| Study group | Role | What they receive |
|---|---|---|
| carbon-ion radiotherapy for tumor away from GI | Experimental | For tumor location which is away from gastrointestine (the distance is more than 1 cm). We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Four dose levels [55 Gray equivalent (GyE)/10 fractions (Fx), 60GyE/10Fx, 65GyE/10Fx, 70GyE/10Fx] are planned within the Phase I part. Receives: Radiation: carbon-ion radiotherapy for tumor away from GI |
| carbon-ion radiotherapy for tumor adjacent to GI | Experimental | For tumor location which is adjacent to gastrointestine (less than 1 cm).We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma.
Three dose levels (carbon 60GyE/15Fx, carbon 67.5GyE/15Fx, carbon 75GyE/15Fx) are planned within the Phase I part. Receives: Radiation: carbon-ion radiotherapy for tumor adjacent to GI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Time interval from the start of CIRT to 3 months after the completion of CIRT
Secondary outcomes (3)
Overall survival of all patients
Overall survival of all patients
Measured: From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
Progression-free survival of all patients
Progression-free survival of all patients
Measured: From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
Number of participants with tumor response as assessed by RECIST 1.1
Number of participants with tumor response as assessed by RECIST 1.1
Measured: Time interval from the start of CIRT to 3 months after the completion of CIRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJun 2015
- Primary completionOct 2023
- Study completionOct 2023
Why it stopped: For tumor locates away from GI the planned enrolled patient had been completed, but for tumor locates closely to GI only 6 patients had been enrolled because not many eligible patients were available.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- guoliang Jiang, Prof., Principal investigator, Shanghai Proton and Heavy Ion Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802124
- Sponsor's protocol ID
- SPHIC-TR-HCC2016-01
- Status last verified
- Nov 2023
- First submitted
- 12 Jun 2016
- Last updated
- 7 Dec 2023
- 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 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02802124
- Acronym / sponsor ID
- SPHIC-TR-HCC2016-01
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, carbon-ion radiotherapy, toxicity, efficacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For tumor locates away from GI the planned enrolled patient had been completed, but for tumor locates closely to GI only 6 patients had been enrolled because not many eligible patients were available.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Proton and Heavy Ion CenterUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Oct 2023 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 16 Jun 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 feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese hepatocellular carcinoma
Detailed description
The purpose of this study is to determine the maximal tolerated dose (MTD) of carbon ion radiotherapy (CIRT) in the treatment of localized Chinese hepatocellular carcinoma with respective to toxicity and tumor control. Participants will be treated with CIRT with escalating dose regimens based on the tumor location to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 3 months after the completion of CIRT. Primary endpoint is toxicity, second endpoint is progression-free survival, overall survival and tumor response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carbon-ion radiotherapy for tumor away from GI | Experimental | Radiation: carbon-ion radiotherapy for tumor away from GIFor tumor location which is away from gastrointestine (the distance is more than 1 cm). We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Four dose levels [55 Gray equivalent (GyE)/10 fractions (Fx), 60GyE/10Fx, 65GyE/10Fx, 70GyE/10Fx] are planned within the Phase I part. |
| carbon-ion radiotherapy for tumor adjacent to GI | Experimental | Radiation: carbon-ion radiotherapy for tumor adjacent to GIFor tumor location which is adjacent to gastrointestine (less than 1 cm).We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Three dose levels (carbon 60GyE/15Fx, carbon 67.5GyE/15Fx, carbon 75GyE/15Fx) are planned within the Phase I part. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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;
- Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 cm;
- age ≥ 18 and <80 years of age;
- Karnofsky Performance Score ≥ 70;
Key exclusion criteria (9 listed)
- Distant metastasis (M1);
- maximal tumor size is more than 12 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 radiotherapy for tumor away from GI | Radiation | carbon-ion radiotherapy for tumor away from GI |
| carbon-ion radiotherapy for tumor adjacent to GI | Radiation | carbon-ion radiotherapy for tumor adjacent to GI |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Time interval from the start of CIRT to 3 months after the completion of CIRT
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
3 secondary outcomes
Overall survival of all patients
Time frame: From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
Progression-free survival of all patients
Time frame: From the diagnosis of localized hepatocellular carcinoma, a median of 2 years
Number of participants with tumor response as assessed by RECIST 1.1
Time frame: Time interval from the start of CIRT to 3 months after the completion of CIRT
Results and safety
The study was stopped early (reason given: For tumor locates away from GI the planned enrolled patient had been completed, but for tumor locates closely to GI only 6 patients had been enrolled because not many eligible patients were available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
guoliang Jiang, Prof. principal investigator
Shanghai Proton and Heavy Ion Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carbon-ion radiotherapy for tumor away from GI and carbon-ion radiotherapy for tumor adjacent to GI in people with Hepatocellular Carcinoma, run by Shanghai Proton and Heavy Ion Center 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 7 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: stopped early, as of the sponsor's last update on 7 Dec 2023. 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.
Are results available for this study?
The study was stopped early (reason given: For tumor locates away from GI the planned enrolled patient had been completed, but for tumor locates closely to GI only 6 patients had been enrolled because not many eligible patients were available.). 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Time interval from the start of CIRT to 3 months after the completion of CIRT). 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 Dec 2023.