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New treatment option for Hepatocellular Carcinoma
Official title Phase II Study of Moderate-dose Hypofractionated RT Combined With Pembrolizumab for HCC With Diffuse Tumor Thrombosis
ClinicalTrials.gov ID: NCT06389422
What this study is testing
What is Pembrolizumab?
Pembrolizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, single-arm, open-label study that includes patients meeting the inclusion criteria (liver-GTV volume \< 700ml or estimated liver-GTV V5 \< 300ml) with hepatocellular carcinoma with diffuse tumor thrombosis involving both left and right lobes. All lesions receive moderate-dose hypofractionated intensity-modulated radiotherapy, with a gross tumor dose of 25Gy/5f, and a maximum dose of 35Gy/5f at the tumor center.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Confirmed clinically or histopathologically as hepatocellular carcinoma, concurrently with portal vein thrombosis or hepatic vein thrombosis;
- Age 18-90 years;
- 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...
- Allowed previous treatment including TACE, RFA, surgery, chemotherapy, targeted therapy, etc., but not including ICIs such as anti-PD-1, anti-PD-L1...
- ECOG performance status 0-2, expected survival greater than 1 month;
You likely can't join if
- Currently participating in other clinical trials;
- Previously received abdominal radiotherapy or liver transplantation;
- Individuals with severe chronic disease conditions affecting vital organs such as the heart, kidneys, or liver;
- Severe ascites with noticeable symptoms, anticipated to be unrelieved after treatment.
- Suspected or confirmed drug addiction, medicine abuse,or alcoholism
- Pregnant or lactating women;
See the full eligibility criteria
- Confirmed clinically or histopathologically as hepatocellular carcinoma, concurrently with portal vein thrombosis or hepatic vein thrombosis;
- Age 18-90 years;
- 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;
- 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;
- ECOG performance status 0-2, expected survival greater than 1 month;
- Allowing patients with distant metastases;
- Child-Pugh A5, A6, B7 and B8;
- ALT within 2.5 times the normal upper limit; AST within 2.5 times the normal upper limit; TBIL \<60umol/L.
- No significant abnormalities in the electrocardiogram, no apparent heart failure, and no contraindications for anti-PD-1 treatment;
- CRE, BUN within 2.5 times the normal upper limit;
- 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;
- Patients voluntarily participate in this clinical trial and sign an informed consent form.
- Currently participating in other clinical trials;
- Previously received abdominal radiotherapy or liver transplantation;
- Individuals with severe chronic disease conditions affecting vital organs such as the heart, kidneys, or liver;
- Severe ascites with noticeable symptoms, anticipated to be unrelieved after treatment.
- Suspected or confirmed drug addiction, medicine abuse,or alcoholism
- Pregnant or lactating women;
- Severe mental or neurological disorders
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.