NCT04150744 RFA Plus Carrizumab vs Carrizumab Alone for HCC
| NCT ID | NCT04150744 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Tumor Immunity |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2020-08-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2020-08-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age from 18-75 years 2. Diagnosis as hepatocellular carcinoma from histology and cytology 3. BCLC B-C degree 4. Score of ECOG PS: 0-2 5. Child-Pugh Score: A or B 6. Not suitable for resection or liver transplantation 7. Have not received systemic therapy 8. Have at least one evaluable target mass from CT or MRI according to mRECIST 9. The estimated survival time ≥ 12 weeks 10. Patients with HBV infection having HBV-DNA \<500IU/mL and standard anti-virus treatment. Patients with HCV infection must receive standard anti-virus treatment. 11. The function of main organs normal 12. Sign informed consent Exclusion Criteria: 1. Have cholangiocarcinoma, mixed type of hepatocarcinoma and fibrolamellar hepatocellular carcinoma. Have incurable malignant tumor in five years. 2. Have local ablation, TACE or radiotherapy in 3 months before enrolled. 3. Prepared to or have received organic or bone marrow transplantation. 4. Uncontrollable ascites, hepatic encephalopathy or esophageal and gastric varices. 5. Have hypertension and can't lower down to the normal level using blood pressure medication. 6. Have type II myocardial ischemia or myocardial infarction, uncontrollable arrhythmia. 7. Have diseases to influent the effect of oral drugs, for example, unable to swallow, chronic diarrhea and intestinal obstruction. 8. Have gastrointestinal bleeding in 6 months 9. Have abdominal fistula, gastrointestinal perforation or abdominal abscess 10. Patients with lung fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug related pneumonia or severe dysfunction of lung. 11. Routine urine test showed urinary protein ≥++ or the 24 hours amount of urinary protein ≥1.0 g 12. Patients have autoimmune disease 13. Patients need corticosteroid or other immunosuppressant therapy 14. Patients have anti-tumor vaccine and other immunostimulate anti-tumor drugs in 3 months 15. Allergy to monocloning antibody 16. Pregnant or breastfeeding female Other patients not suitable to be enrolled in the study.
Contact & Investigator
Zhe Tang, Dr.
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, Zhejiang University, School of Medicine
Frequently Asked Questions
Who can join the NCT04150744 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Tumor Immunity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04150744 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04150744 currently recruiting?
Yes, NCT04150744 is actively recruiting participants. Contact the research team at 8xi@zju.edu.cn for enrollment information.
Where is the NCT04150744 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT04150744 clinical trial?
NCT04150744 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is Zhe Tang, Dr. at Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 120 participants.