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

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with hepatocellular carcinoma (a type of liver cancer) that has spread into the blood vessels (known as tumor thrombosis). The trial combines a type of radiation therapy called moderate-dose hypofractionated radiotherapy with a medication called Pembrolizumab, which helps the immune system fight cancer. Participants will receive radiation aimed at the tumor and Pembrolizumab either one week before or during the radiation treatment, followed by additional doses of Pembrolizumab every three weeks. The main goal of the study is to find out how long patients survive after treatment, and they will also look at how well the treatment works and any side effects that occur.

To be eligible for this trial, patients need to be between 18 and 90 years old and have confirmed liver cancer along with blood vessel involvement. They should have a certain size of liver tumor and meet specific health criteria. Participants will be closely monitored after their treatment, with follow-up appointments in the months that follow. It's important for potential participants to know that they will have the chance to receive other supportive treatments if needed, and they must give their consent to be part of this research. This study is currently recruiting participants, so there is an opportunity for those who meet the criteria to join and contribute to advancing cancer treatment.

Gender

ALL

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).