Carcinoma; HepatocellularNCT05596630
Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent HCC
A study testing Stereotactic body radiation therapy in people with Carcinoma; Hepatocellular, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Primary liver cancer is one of the common malignant tumors in China, of which hepatocellular carcinoma (HCC) accounts for 85%-90%. It is worth noting that the recurrence rate of liver cancer is greater than 10% at 1 year after surgery, while the recurrence rate in 5 years reaches 70-80%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carcinoma; Hepatocellular
- What is being tested?
- Stereotactic body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Clinical or pathological diagnosis of HCC without lymph node and distant metastasis.
- 2. Previous surgery or radiofrequency ablation, no recurrence within 6 months. 3. Early stage liver cancer within Milan criteria : (1) single tumor diameter less than 5 cm; (2) not more than three foci of tumor, each one not exceeding 3 cm; (3) no angioinvasion; (4) no extrahepatic involvement.
- 4. The remnant liver volume beyond the radiotherapy target area should be greater than 700ml.
- 5. No serious hematological, heart, lung, hepatic, renal dysfunction and immunodeficiency.
- 6. Hemoglobin (Hb)≥8g/dL ; white blood cell (WBC) ≥ 210^9/L ; neutrophils (ANC) ≥ 1.0 10^9/L ; platelet (Pt) ≥ 5010^9/L.
- 7. Men or women with fertility are willing to take contraceptive measures in the trial.
- 8. ECOG score standard 0 ~ 1 ; child-pugh score A-B . 9. Expected survival period > 3 months. 10. Voluntary participation and signing of informed consent.
Who cannot join
- 1. Patients who have undergone antitumor therapy for liver cancer. 2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points.
- 3. Total bilirubin exceed the upper limit of normal 1.5 times, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 2.5 times, ICGR15≥40%.
- 4. Patients undergoing major surgery within 1 month of study initiation. 5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years).
- 6. Participants in other clinical trials within 30 days prior to study treatment.
- 7. The distance between the tumor and the gastrointestinal tract < 0.5 cm. 8. Pregnancy, lactation or those with fertility but without contraceptive measures.
- 9. Patients with drug addiction such as drugs, long-term alcoholism, and AIDS. 10. Patients have an uncontrollable epileptic seizure, or lose insight due to mental illness.
- 11. Patients with severe allergic history or specific constitution. 12. Researchers consider it inappropriate to participate in the test.
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
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
weilin wang, +86 0571 87783820, wam@zju.edu.cn
About this study
Official title: A Single-center, Unblinded, Single-arm, Prospective Trial of Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent Hepatocellular Carcinoma
Primary liver cancer is one of the common malignant tumors in China, of which hepatocellular carcinoma (HCC) accounts for 85%-90%. It is worth noting that the recurrence rate of liver cancer is greater than 10% at 1 year after surgery, while the recurrence rate in 5 years reaches 70-80%.
Stereotactic body radiation therapy (SBRT) refers to a kind of radiotherapy technology to achieve a steep dose gradient and achieve high-precision position and high-dose fractionated irradiation. The rapid dose drop-down enables SBRT to maximize the protection of normal tissues around the tumor, and it often requires only 1-5 times of high-dose fractionated irradiation to complete the course of treatment.SBRT may play an important role in the treatment of small intrahepatic recurrence HCC, but there is still a lack of evidence of high-level prospective studies.
We intend to conduct a single-center, prospective, clinical study to further elaborate the efficacy and safety of SBRT in the treatment of small intrahepatic recurrent HCC.
Read the detailed description
Patients with recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chosen for this study. A total of 40 patients will be scheduled to be enrolled. The patients enrolled will be treated with SBRT with no adjuvant therapy, and they will be followed up according to the plan.
- Conditions
- Carcinoma; Hepatocellular
- Being tested
- Stereotactic body radiation therapy
- Keywords
- Stereotactic Body Radiation Therapy, Recurrent Hepatocellular Carcinoma, Small liver cancer
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiation therapyRadiation
Stereotactic body radiotherapy for small intrahepatic recurrent HCC. Radiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Radiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week. Receives: Radiation: Stereotactic body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate（LC）
The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)
Measured: up to 24 months after SBRT
Secondary outcomes (5)
Short time Safety profile of SBRT
Toxicities appeared during SBRT treatment and up to 3 months after SBRT. Toxicities will be assessed by the evaluation of intensity and incidence of the Adverse Events (AE) displayed by patients. The intensity of each AE will be classified according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: up to 3 months after SBRT
Overall response rate (ORR)
According to RECIST v1.1, the proportion of patients with at least one complete response (CR) or partial response (PR) (%)
Measured: up to 24 months after SBRT
Overall survival (OS)
The time between the date of SBRT and death from any cause
Measured: up to 24 months
Local recurrence rate (LRR)
Rate of intrahepatic hepatocellular carcinoma recurrence
Measured: up to 24 months after SBRT
Progression-free survival (PFS)
The time between the date of SBRT and the date of radiographic progression as defined by RECIST1.1
Measured: up to 24 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 2022
- Study start1 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma; HepatocellularStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596630
- Sponsor's protocol ID
- 2022-0771
- Status last verified
- Jan 2025
- First submitted
- 25 Oct 2022
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Unblinded, Single-arm, Prospective Trial of Stereotactic Body Radiation Therapy for the Safety and Prognosis of Small Intrahepatic Recurrent Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05596630
- Acronym / sponsor ID
- 2022-0771
- Conditions
- Carcinoma; Hepatocellular
- Keywords
- Stereotactic Body Radiation Therapy, Recurrent Hepatocellular Carcinoma, Small liver cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Oct 2022 (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.
Primary liver cancer is one of the common malignant tumors in China, of which hepatocellular carcinoma (HCC) accounts for 85%-90%. It is worth noting that the recurrence rate of liver cancer is greater than 10% at 1 year after surgery, while the recurrence rate in 5 years reaches 70-80%.
Stereotactic body radiation therapy (SBRT) refers to a kind of radiotherapy technology to achieve a steep dose gradient and achieve high-precision position and high-dose fractionated irradiation. The rapid dose drop-down enables SBRT to maximize the protection of normal tissues around the tumor, and it often requires only 1-5 times of high-dose fractionated irradiation to complete the course of treatment.SBRT may play an important role in the treatment of small intrahepatic recurrence HCC, but there is still a lack of evidence of high-level prospective studies.
We intend to conduct a single-center, prospective, clinical study to further elaborate the efficacy and safety of SBRT in the treatment of small intrahepatic recurrent HCC.
Detailed description
Patients with recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chosen for this study. A total of 40 patients will be scheduled to be enrolled. The patients enrolled will be treated with SBRT with no adjuvant therapy, and they will be followed up according to the plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiation therapy | Experimental | Radiation: Stereotactic body radiation therapyRadiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Clinical or pathological diagnosis of HCC without lymph node and distant metastasis.
- 2. Previous surgery or radiofrequency ablation, no recurrence within 6 months. 3. Early stage liver cancer within Milan criteria : (1) single tumor diameter less than 5 cm; (2) not more than three foci of tumor, each one not exceeding 3 cm; (3) no angioinvasion; (4) no extrahepatic involvement.
- 4. The remnant liver volume beyond the radiotherapy target area should be greater than 700ml.
- 5. No serious hematological, heart, lung, hepatic, renal dysfunction and immunodeficiency.
- 6. Hemoglobin (Hb)≥8g/dL ; white blood cell (WBC) ≥ 210^9/L ; neutrophils (ANC) ≥ 1.0 10^9/L ; platelet (Pt) ≥ 5010^9/L.
Key exclusion criteria (7 listed)
- 1. Patients who have undergone antitumor therapy for liver cancer. 2. Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points.
- 3. Total bilirubin exceed the upper limit of normal 1.5 times, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 2.5 times, ICGR15≥40%.
- 4. Patients undergoing major surgery within 1 month of study initiation. 5. Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years).
- 6. Participants in other clinical trials within 30 days prior to study treatment.
- 7. The distance between the tumor and the gastrointestinal tract < 0.5 cm. 8. Pregnancy, lactation or those with fertility but without contraceptive measures.
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 |
|---|---|---|
| Stereotactic body radiation therapyStereotactic body radiotherapy for small intrahepatic recurrent HCC. Radiation dose: Greater than or equal to 40Gy/4-5F, complete treatment within 1 week. | Radiation | Stereotactic body radiation therapy |
Primary outcome
Local control rate（LC）
Time frame: up to 24 months after SBRT
The treatment efficacy is assessed by calculation of local control rate of irradiated locations according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (complete response + partial response + stable disease)
5 secondary outcomes
Short time Safety profile of SBRT
Time frame: up to 3 months after SBRT
Overall response rate (ORR)
Time frame: up to 24 months after SBRT
Overall survival (OS)
Time frame: up to 24 months
Local recurrence rate (LRR)
Time frame: up to 24 months after SBRT
Progression-free survival (PFS)
Time frame: up to 24 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 10 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiation therapy in people with Carcinoma; Hepatocellular, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 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 10 Feb 2025. 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?
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 Weilin Wang, doctor (+86 0571 87783820, wam@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control rate（LC） (time frame: up to 24 months after SBRT). 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 10 Feb 2025.