NCT06397222RecruitingPhase 2
Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC
Sintilimab, Bevacizumab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial
Source: ClinicalTrials.gov · Last updated 7 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (estimated)
- First submitted
- 29 Apr 2024
- Start date
- 1 May 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06397222
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 23
- From 1 May 2024 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy for HCC
- Prior esophageal and/or gastric varices bleeding
- Use of immunosuppressive medications within 4 weeks prior to the first dose of study treatment
- Major surgical procedure or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose of study treatment
- Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion, surgical or localized treatment, or ongoing drug therapy
Other illness
- Metastatic disease that involves major airways or blood vessels
- History of organ and cell transplantation
- Evidence of portal hypertension with high risk of bleeding
- Severe organ (heart, lung, kidney) dysfunction
- History of other malignancies
- Co-infection with hepatitis B and C viruses
- Human immunodeficiency virus infection
Lab values
- Peripheral blood white blood cell count \<3×10\^9/L and platelet count \<50×10\^9/L
Other
- tumor extent ≥70% liver occupation
- Tumor thrombus involving main portal vein or both the first left and right branches of portal vein
- Vena cava invasion
- Central nervous system metastasis
- Hepatic dysfunction, such as ascites, esophagogastric varices, hepatic encephalopathy
- Prolonged prothrombin time \>4 seconds
- Pregnant or lactating patients
Who the study is looking for
- Unresectable HCC (BCLC stage B/C or CNLC II/III) with diagnosis confirmed by histology/cytology or clinically
- At least one measurable untreated lesion
- Intrahepatic tumors can be treated with 1-2 sessions of SIRT
- Child-Pugh score 5-7
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Life expectancy of at least 3 months
- Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL
- Patients with hepatitis C need to finish the anti-HCV treatment
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.