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New treatment option for Hepatocellular Carcinoma (HCC)
Official title Sintilimab Combined SBRT As Neoadjuvant Therapy for Resectable HCC with PVTT
ClinicalTrials.gov ID: NCT06664996
What this study is testing
What is Sintilimab (approved)?
Sintilimab (approved) is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma (hcc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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: 1.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Diagnosis of hepatocellular carcinoma confirmed either histologically, cytologically, or based on characteristic imaging features (ultrasound, CT...
- 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...
You likely can't join if
- Previous treatments including treatment, 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.
See the full eligibility criteria
- 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.
- No prior treatments including targeted therapy, systemic chemotherapy, treatment 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...
- 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...
- Previous treatments including treatment, 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.