Moderate-dose radiotherapy combined with Pembrolizumab for liver cancer with blood vessel blockage
Phase II Study of Moderate-dose Hypofractionated Radiotherapy Combined With Pembrolizumab for Hepatocellular Carcinoma With Diffuse Tumor Thrombosis Involved Both Left and Right Liver
This study is testing if combining a specific type of radiation therapy with the immunotherapy drug Pembrolizumab can help people with liver cancer that has blocked blood vessels feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, Pembrolizumab, Lenvatinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06389422 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-90 with confirmed hepatocellular carcinoma and portal or hepatic vein thrombosis.
Not a fit: Patients who have previously received immune checkpoint inhibitors or have significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve overall survival rates for patients with advanced liver cancer and tumor thrombosis.
How similar studies have performed: While there have been studies exploring similar combinations of radiotherapy and immunotherapy, this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Beijing, Beijing Municipality
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciecnces and Peking Union Medical College — Beijing, Beijing Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.