Sintilimab Combined SBRT As Neoadjuvant Therapy for Resectable HCC with PVTT
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this 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: 1. Is the combination of sintilimab and SBRT safe as neoadjuvant therapy? 2. 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.
Sponsor: West China Hospital
You may qualify 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, 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, interventional treatments, surgical interventions, or radiotherapy before enrollment.
- ✓ Expected survival of at least 3 months.
You may not qualify if…
- ✕ 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.
- ✕ Severe bone marrow failure.
- ✕ Diagnosis of active autoimmune disease requiring any form of systemic treatment.
Source: ClinicalTrials.gov · NCT06664996 · last updated 2024-10-30