Hepatocellular CarcinomaPhase 2NCT06205472
Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
A Phase 2 study testing Adjuvant SIB radiotherapy in people with Hepatocellular Carcinoma and Narrow Margin, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Narrow Margin, Radiotherapy
- What is being tested?
- Adjuvant SIB radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 26 Jan 2024to 12 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (< 1 cm)
- Age > 18 years
- Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1
- Child-Push Score: A5-A6
- Estimated life expectancy > 3 months
- No distant metastasis (M0)
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- Blood routine examination: Hb≥80g/L, ANC≥1.0x10^9/L, PLT≥50x10^9/L
- Hepatic function: alanine transaminase(ALT) and aspartate transaminase(AST) ≤1.5 times ULN; or ALT ≤ULN and AST ≤6 times ULN exclude possibility of heart disease
- Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN
- Voluntary to participate and sign informed consent
Who cannot join
- History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
- Had prior abdominal irradiation
- Had prior liver transplantation
- Had serious myocardial disease or renal failure
- Had moderate or severe ascites with obvious symptoms
- Duration from surgery ≥ 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Bo Chen
Beijing
Bo Chen, 00861324000876, chenboo@outlook.com
Yirui Zhai
About this study
Official title: Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.
Read the detailed description
Surgical resection is the primary treatment for HCC. However, it is associated with a high rate of recurrence and death. Based on the results of our retrospective study and phase II study, adjuvant radiotherapy is an effective, tolerable, and promising adjuvant regimen in patients with narrow-margin(<1cm) after hepatectomy. The 3-year and 5-year OS rates of 88.2% and 72.2% were significantly higher than the expected rates based on published reports and exceeded our predetermined threshold. However, there is no standard for the prescription dose. The high risk area of recurrence is mostly close to the blood vessels in the tumor bed, and simultaneously integrated boost (SIB) technique can optimize the target dose while protecting normal tissues. So, the investigators conducted this single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant SIB radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC.
- Conditions
- Hepatocellular Carcinoma, Narrow Margin, Radiotherapy
- Being tested
- Adjuvant SIB radiotherapy
- Keywords
- Hepatocellular Carcinoma, Narrow Margin, Adjuvant Simultaneously Integrated Boost Radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant SIB radiotherapyRadiation
Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions,mainly depending on the dose constraints of OARs.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant SIB radiotherapy | Experimental | Adjuvant integrated boost radiotherapy following narrow-margin hepatectomy in patients with HCC. Receives: Radiation: Adjuvant SIB radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 3-year Overall Survival
The 3-year overall survival was calculated from the date of surgical resection to the date of death from any cause.
Measured: up to 36 months
Secondary outcomes (4)
Disease-free Survival (DFS)
Disease-free survival (DFS) was calculated from the date of surgical resection to the date of the first recurrence or death from HCC
Measured: up to 36 months
Pattern of Failure
The type of recurrence (locoregional failures or distant failure)
Measured: up to 36 months
Toxic Events
Toxic events was evaluated during received protocol therapy according to CTCAE 4.03
Measured: up to 36 months
Local Control Rate
Patients with stable disease [SD], partial response [PR] or complete response[CR] were recorded as local control.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start26 Jan 2024 (estimated)
- Primary completion12 Dec 2025 (estimated)
- Study completion12 Dec 2026 (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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BO CHEN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205472
- Sponsor's protocol ID
- NCC4255
- Status last verified
- Jan 2024
- First submitted
- 25 Dec 2023
- Last updated
- 16 Jan 2024
- 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 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.
- ClinicalTrials.gov ID
- NCT06205472
- Acronym / sponsor ID
- NCC4255
- Conditions
- Hepatocellular Carcinoma, Narrow Margin, Radiotherapy
- Keywords
- Hepatocellular Carcinoma, Narrow Margin, Adjuvant Simultaneously Integrated Boost Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 26 Jan 2024 (estimated)
- Primary completion
- 12 Dec 2025 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 16 Jan 2024 (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 is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.
Detailed description
Surgical resection is the primary treatment for HCC. However, it is associated with a high rate of recurrence and death. Based on the results of our retrospective study and phase II study, adjuvant radiotherapy is an effective, tolerable, and promising adjuvant regimen in patients with narrow-margin(<1cm) after hepatectomy. The 3-year and 5-year OS rates of 88.2% and 72.2% were significantly higher than the expected rates based on published reports and exceeded our predetermined threshold. However, there is no standard for the prescription dose. The high risk area of recurrence is mostly close to the blood vessels in the tumor bed, and simultaneously integrated boost (SIB) technique can optimize the target dose while protecting normal tissues. So, the investigators conducted this single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant SIB radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adjuvant SIB radiotherapy | Experimental | Radiation: Adjuvant SIB radiotherapyAdjuvant integrated boost radiotherapy following narrow-margin hepatectomy in patients with HCC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (< 1 cm)
- Age > 18 years
- Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1
- Child-Push Score: A5-A6
- Estimated life expectancy > 3 months
Key exclusion criteria (6 listed)
- History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
- Had prior abdominal irradiation
- Had prior liver transplantation
- Had serious myocardial disease or renal failure
- Had moderate or severe ascites with obvious symptoms
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 |
|---|---|---|
| Adjuvant SIB radiotherapyEligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions,mainly depending on the dose constraints of OARs. | Radiation | Adjuvant SIB radiotherapy |
Primary outcome
The 3-year Overall Survival
Time frame: up to 36 months
The 3-year overall survival was calculated from the date of surgical resection to the date of death from any cause.
4 secondary outcomes
Disease-free Survival (DFS)
Time frame: up to 36 months
Pattern of Failure
Time frame: up to 36 months
Toxic Events
Time frame: up to 36 months
Local Control Rate
Time frame: up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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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.
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 Adjuvant SIB radiotherapy in people with Hepatocellular Carcinoma and Narrow Margin, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 6 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: looking for participants now, as of the sponsor's last update on 16 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Chen, MD (00861324000876, chenboo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 3-year Overall Survival (time frame: up to 36 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 16 Jan 2024.