Hepatocellular Carcinoma (HCC)Phase 2NCT06664996
Sintilimab Combined SBRT As Neoadjuvant Therapy for Resectable HCC with PVTT
A Phase 2 study testing stereotactic body radiation therapy (SBRT) and Sintilimab (approved) in people with Hepatocellular Carcinoma (HCC), run by West China Hospital at 1 site in China.
Trial summary
The goal of this single-arm, prospective clinical trial is to evaluate the safety and efficacy of neoadjuvant therapy combining sintilimab with stereotactic body radiation therapy (SBRT) in patients with resectable hepatocellular carcinoma (HCC) with branch portal vein tumor thrombus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- stereotactic body radiation therapy (SBRT) and Sintilimab (approved)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to Oct 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years, regardless of gender.
- Voluntary participation, as evidenced by signed informed consent, with the willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Diagnosis of hepatocellular carcinoma confirmed either histologically, cytologically, or based on characteristic imaging features (ultrasound, CT, MRI) and laboratory tests.
- Presence of measurable disease lesions per modified RECIST (mRECIST) criteria.
- Visible branch portal vein tumor thrombus (Japanese classification Vp1-Vp3 or Cheng's classification I-II) on imaging, deemed resectable after multidisciplinary consultation.
- No history of other malignancies.
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- No prior treatments including targeted therapy, systemic chemotherapy, interventional treatments, surgical interventions, or radiotherapy before enrollment.
- Expected survival of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Liver function classified as Child-Pugh A (score ≤6).
- Adequate organ and bone marrow function indicated by: serum creatinine ≤1.5 times the upper limit of normal, estimated glomerular filtration rate ≥50 mL/min/1.73m^2; total bilirubin ≤2 times the upper limit of normal; AST and ALT ≤2.5 times the upper limit of normal; AST/ALT ratio ≤3 times the upper limit of normal; platelet count ≥70×10^9/L, white blood cells count ≥3000/mm^3, and absolute neutrophil count ≥1500/mm^3 without transfusion to meet entry criteria.
- Female participants of childbearing potential must have a negative serum pregnancy test within 3 days prior to the commencement of the study medication, agree to use a highly effective method of contraception (e.g., intrauterine device, contraceptives, or condoms) during the study period and for 3 months after the last dose of study medication. Male participants with partners of childbearing potential must be surgically sterile or agree to use effective contraception during the study period and for 3 months after the last dose of study medication.
Who cannot join
- Previous treatments including interventional, immunotherapy, chemotherapy, or targeted therapy.
- Presence of confirmed distant metastasis on imaging or portal vein tumor thrombus involving the main portal vein (Vp4).
- Presence of refractory ascites or hepatic encephalopathy.
- Concurrent malignancy in other organs.
- Impaired organ function (hematologic, hepatic, renal) that precludes tolerance of treatment.
- Significant cardiac arrhythmias, myocardial ischemia, severe atrioventricular block, heart failure, or severe valvular heart disease.
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- Severe bone marrow failure.
- Diagnosis of active autoimmune disease requiring any form of systemic treatment.
- Participation in another oncology clinical trial within the last 3 months.
- History of active tuberculosis or persistent, uncontrollable infections.
- Pregnant or breastfeeding participants.
- History of infection with the Human Immunodeficiency Virus (HIV).
- Any condition that, in the opinion of the investigator, would make participation in the study inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Yi Yang, doctor, +8618328699953, yy_devin@163.com
About this study
Official title: Sintilimab Combined with Stereotactic Body Radiation Therapy As Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma with Branch Portal Vein Tumor Thrombus: a Single-arm, Prospective Clinical Study
The goal of this single-arm, prospective clinical trial is to evaluate the safety and efficacy of neoadjuvant therapy combining sintilimab with stereotactic body radiation therapy (SBRT) in patients with resectable hepatocellular carcinoma (HCC) with branch portal vein tumor thrombus. The main questions it aims to answer are:
- Is the combination of sintilimab and SBRT safe as neoadjuvant therapy?
- How effective is this combination in treating resectable HCC with branch PVTT? Participants will be given a combination treatment of sintilimab and SBRT. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- stereotactic body radiation therapy (SBRT), Sintilimab (approved)
- Keywords
- Branch 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.
stereotactic body radiation therapy (SBRT)Radiation
SBRT will be administered on days 1, 3, and 5 at a dose of 8 Gy per fraction, totaling 3 fractions.
Sintilimab (approved)Drug
patients will receive a first dose of sintilimab at 200 mg on day 1, followed by a second dose of 200 mg on day 22 (week 4, ±3 days).
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | After obtaining informed consent, patients will undergo neoadjuvant therapy combining SBRT with sintilimab. SBRT will be administered on days 1, 3, and 5 at a dose of 8 Gy per fraction, totaling 3 fractions. Concurrently, patients will receive a first dose of sintilimab at 200 mg on day 1, followed by a second dose of 200 mg on day 22 (week 4, ±3 days). A radical hepatectomy is scheduled for day 50 (week 8, ±7 days). Tumor response will initially be evaluated using RECIST v1.1 criteria starting from the first administration, with a second pre-operative tumor imaging assessment at week 8 (±7 days). Post-surgery, patients will begin adjuvant treatment with sintilimab 200 mg every 3 weeks, continuing for 24 weeks. Follow-up assessments will occur every 3 months (±7 days) to collect data on disease status and survival, with a total follow-up duration of 1 year for each patient. This structured approach ensures precise timing and dosing while maintaining academic rigor and a logical sequen Receives: Radiation: stereotactic body radiation therapy (SBRT); Drug: Sintilimab (approved) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year Disease-Free Survival (DFS) rate
Measured: DFS rate will be measured for each patient starting from the date they begin the treatment until one year after that date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start15 Oct 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wentao Wang, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664996
- Sponsor's protocol ID
- 2024-667
- Status last verified
- Jul 2024
- First submitted
- 28 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sintilimab Combined with Stereotactic Body Radiation Therapy As Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma with Branch Portal Vein Tumor Thrombus: a Single-arm, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06664996
- Acronym / sponsor ID
- 2024-667
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Branch Portal Vein Tumor Thrombus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 30 Oct 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.
The goal of this single-arm, prospective clinical trial is to evaluate the safety and efficacy of neoadjuvant therapy combining sintilimab with stereotactic body radiation therapy (SBRT) in patients with resectable hepatocellular carcinoma (HCC) with branch portal vein tumor thrombus. The main questions it aims to answer are:
- Is the combination of sintilimab and SBRT safe as neoadjuvant therapy?
- How effective is this combination in treating resectable HCC with branch PVTT? Participants will be given a combination treatment of sintilimab and SBRT. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Radiation: stereotactic body radiation therapy (SBRT), Drug: Sintilimab (approved)After obtaining informed consent, patients will undergo neoadjuvant therapy combining SBRT with sintilimab. SBRT will be administered on days 1, 3, and 5 at a dose of 8 Gy per fraction, totaling 3 fractions. Concurrently, patients will receive a first dose of sintilimab at 200 mg on day 1, followed by a second dose of 200 mg on day 22 (week 4, ±3 days). A radical hepatectomy is scheduled for day 50 (week 8, ±7 days). Tumor response will initially be evaluated using RECIST v1.1 criteria starting from the first administration, with a second pre-operative tumor imaging assessment at week 8 (±7 days). Post-surgery, patients will begin adjuvant treatment with sintilimab 200 mg every 3 weeks, continuing for 24 weeks. Follow-up assessments will occur every 3 months (±7 days) to collect data on disease status and survival, with a total follow-up duration of 1 year for each patient. This structured approach ensures precise timing and dosing while maintaining academic rigor and a logical sequen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age greater than 18 years, regardless of gender.
- Voluntary participation, as evidenced by signed informed consent, with the willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Diagnosis of hepatocellular carcinoma confirmed either histologically, cytologically, or based on characteristic imaging features (ultrasound, CT, MRI) and laboratory tests.
- Presence of measurable disease lesions per modified RECIST (mRECIST) criteria.
- Visible branch portal vein tumor thrombus (Japanese classification Vp1-Vp3 or Cheng's classification I-II) on imaging, deemed resectable after multidisciplinary consultation.
Key exclusion criteria (13 listed)
- Previous treatments including interventional, immunotherapy, chemotherapy, or targeted therapy.
- Presence of confirmed distant metastasis on imaging or portal vein tumor thrombus involving the main portal vein (Vp4).
- Presence of refractory ascites or hepatic encephalopathy.
- Concurrent malignancy in other organs.
- Impaired organ function (hematologic, hepatic, renal) that precludes tolerance of treatment.
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 therapy (SBRT)SBRT will be administered on days 1, 3, and 5 at a dose of 8 Gy per fraction, totaling 3 fractions. | Radiation | treatment |
| Sintilimab (approved)patients will receive a first dose of sintilimab at 200 mg on day 1, followed by a second dose of 200 mg on day 22 (week 4, ±3 days). | Drug | treatment |
Primary outcome
1-year Disease-Free Survival (DFS) rate
Time frame: DFS rate will be measured for each patient starting from the date they begin the treatment until one year after that date.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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 stereotactic body radiation therapy (SBRT) and Sintilimab (approved) in people with Hepatocellular Carcinoma (HCC), run by West China Hospital 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 12 inclusion and 13 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 30 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang (+8618328699953, yy_devin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year Disease-Free Survival (DFS) rate (time frame: DFS rate will be measured for each patient starting from the date they begin the treatment until one year after that date.). 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 30 Oct 2024.