Phase II Study of Moderate-dose Hypofractionated RT Combined With Tislelizumab for HCC With Diffuse Tumor Thrombosis

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Jan 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with hepatocellular carcinoma (HCC), a type of liver cancer, who also have tumor thrombosis, meaning that the cancer has spread into the blood vessels of the liver. The study looks at combining a specific type of radiation therapy, called moderate-dose hypofractionated radiotherapy, with a medication named Tislelizumab, which helps boost the body's immune response against cancer. Participants will receive radiation therapy along with Tislelizumab and will be monitored for their overall survival and response to the treatment over time.

To be eligible for this trial, participants should be adults aged 18 to 90 with confirmed liver cancer and related blood vessel involvement. Candidates should have a certain size of liver tumor and specific health conditions that allow them to tolerate the treatment. During the trial, participants can expect regular check-ups after their treatment to see how they are doing. It's important to note that some patients might also receive another medication called Lenvatinib if needed. Overall, this study aims to find out if this combined treatment can help improve survival and manage the disease for patients with this challenging condition.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Confirmed clinically or histopathologically as hepatocellular carcinoma, concurrently with portal vein thrombosis or hepatic vein thrombosis;
• • 2. Age 18-90 years;
• • 3. Liver-GTV volume\<700ml or the estimated volume of Liver-GTV receiving less than 5 Gy of irradiation\<300ml but the average dose of Liver-GTV needs to be \<18Gy;
• • 4. Allowed previous treatment including TACE, RFA, surgery, chemotherapy, targeted therapy, etc., but not including ICIs such as anti-PD-1, anti-PD-L1, or anti-PD-L2 therapies;
• • 5. ECOG performance status 0-2, expected survival greater than 1 month;
• • 6. Allowing patients with distant metastases;
• • 7. Child-Pugh A5, A6, B7 and B8;
• • 8. ALT within 2.5 times the normal upper limit; AST within 2.5 times the normal upper limit; TBIL \<60umol/L.
• • 9. No significant abnormalities in the electrocardiogram, no apparent heart failure, and no contraindications for anti-PD-1 treatment;
• • 10. CRE, BUN within 2.5 times the normal upper limit;
• • 11. Hb ≥ 50g/L, ANC ≥ 0.5 × 10\^9 /L, PLT ≥ 30 × 10\^9 /L; patients with a history of gastrointestinal bleeding must be controlled for more than 2 weeks before enrollment with Hb ≥ 60g/L and a significant rising trend;
• • 12. Patients voluntarily participate in this clinical trial and sign an informed consent form.
• Exclusion Criteria:
• • 1. Currently participating in other clinical trials;
• • 2. Previously received abdominal radiotherapy or liver transplantation;
• • 3. Individuals with severe chronic disease conditions affecting vital organs such as the heart, kidneys, or liver;
• • 4. Severe ascites with noticeable symptoms, anticipated to be unrelieved after treatment.
• • 5. Suspected or confirmed drug addiction, medicine abuse,or alcoholism
• • 6. Pregnant or lactating women;
• • 7. Severe mental or neurological disorders
• • 8. Presence of other life-threatening malignancy within the last 3 years before the start of the study (excluding superficial skin cancer, localized low-grade malignant tumor and in situ carcinoma).