Moderate-dose radiotherapy combined with Pembrolizumab for liver cancer with blood vessel blockage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of moderate-dose hypofractionated intensity-modulated radiotherapy combined with Pembrolizumab in patients with hepatocellular carcinoma (HCC) that has caused diffuse tumor thrombosis. The study includes patients with specific liver tumor volume criteria and administers radiotherapy alongside Pembrolizumab, an immunotherapy drug, to enhance treatment efficacy. Participants will receive follow-up examinations to assess overall survival and response rates after treatment. The trial aims to evaluate the potential benefits of this combined approach in improving patient outcomes.

Why it matters

Who can join: the full rules

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).

Where it's running

• National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College
  Beijing, Beijing Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.