Sintilimab Combined SBRT As Neoadjuvant Therapy for Resectable HCC with PVTT

Launched by WEST CHINA HOSPITAL · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with a type of liver cancer called hepatocellular carcinoma (HCC) that has spread to the branch veins, making it more challenging to treat. The researchers want to see if combining two therapies—sintilimab, which helps the body's immune system fight cancer, and stereotactic body radiation therapy (SBRT), a precise form of radiation—can safely help shrink the tumors before surgery. This trial is currently looking for participants aged 18 and older who have been diagnosed with resectable HCC and meet specific health criteria.

If you decide to participate, you will receive both sintilimab and SBRT as part of the treatment plan. The team will closely monitor your health to check how well the treatment works and if it is safe. To be eligible, you should not have had previous treatments for cancer, should not have other serious health issues, and must have a positive outlook for survival. This trial offers a chance to contribute to research that could improve treatment options for others with similar conditions.

Gender

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Eligibility criteria

• Inclusion 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, 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.
• Exclusion Criteria:
• • 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.
• • 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.