NCT06609863Recruiting
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Hepatocellular Carcinoma
dTACE-HAIC Combined With Bevacizumab and Atezolizumab for Huge Intermediate and Advanced Hepatocellular Carcinoma: a Prospective Phase II Study
Source: ClinicalTrials.gov · Last updated 3 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study intends to evaluate the efficacy and safety of drug-eluting transcatheter arterial embolization-hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (dTACE-HAIC) plus Bevacizumab and Atezolizumab for patients with intermediate-advanced huge hepatocellular carcinoma.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 20 Sept 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 1 Oct 2025
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06609863
What you commit to
- Study type: Interventional
- Planned participants: 27
- From 1 Oct 2024 to the primary completion date, 1 Oct 2025
- 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
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Other illness
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- untreated or incompletely treated esophageal or gastric varices (assessed with esophagogastroduodenoscopy) with bleeding or high risk of bleeding.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis.
Other
- Diffuse HCC;
- Extrahepatic metastasis \>5;
- Obstructive PVTT involving mesenteric vena cava (PVTT IV).
- Serious medical comorbidities.
- Eastern Cooperative Group performance status (ECOG) score of ≥2;
Who the study is looking for
- Clinical diagnosis of HCC.
- Age between 18 and 75 years;
- The maximum tumor size ≥10 cm;
- Intermediate-advanced huge HCC, advanced HCC with PVTT type I-III
- limited metastases (≤5).
- Child-Pugh class A or B;
- Eastern Cooperative Group performance status (ECOG) score of 0-1;
- Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
- Prothrombin time ≤18s or international normalized ratio \< 1.7.
- Ability to understand the protocol and to agree to and sign a written informed consent document.
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 |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.