NCT04150744RecruitingPhase 2
RFA Plus Carrizumab vs Carrizumab Alone for HCC
Radiofrequency Ablation Plus Carrizumab vs Carrizumab Alone for Moderate or Advanced Hepatocellular Carcinoma: A Real World Study
Source: ClinicalTrials.gov · Last updated 8 Jul 2020 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The study aims to find whether patients with advanced HCC can get more benefits from RFA +PD-1 immunosuppressant (carrizumab) compared with carrizumab alone, considering with the result of PFS.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 28 Oct 2019
- Start date
- 1 Aug 2020
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04150744
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 120
- From 1 Aug 2020 to the primary completion date, 30 Dec 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
- Have local ablation, TACE or radiotherapy in 3 months before enrolled.
- Prepared to or have received organic or bone marrow transplantation.
- Patients need corticosteroid or other immunosuppressant therapy
- Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months
Other illness
- Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years.
- Have hypertension and can't lower down to the normal level using blood pressure medication.
- Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia.
- Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction.
- Have gastrointestinal bleeding in 6 months
- Have abdominal fistula, gastrointestinal perforation or abdominal abscess
- Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung.
- Patients have autoimmune disease
- Allergy to monocloning antibody
Other
- Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices.
- Routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g
- Pregnant or breastfeeding female Other patients not suitable to be enrolled in the study.
Who the study is looking for
- Age from 18-75 years
- Diagnosis as hepatocellular carcinoma from histology and cytology
- BCLC B-C degree
- Score of ECOG PS: 0-2
- Child-Pugh Score: A or B
- Not suitable for resection or liver transplantation
- Have not received systemic therapy
- Have at least one evaluable target mass from CT or MRI according to mRECIST
- The estimated survival time ≥ 12 weeks
- Patients with HBV infection having HBV-DNA \<500IU/mL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment.
- The function of main organs normal
- Sign informed consent
Age in the registry: 18 years to 75 years · Sex: All · Accepts 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 Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.