Clinical trial · Interventional
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
NCT04150744CI-TRIAL-00045845recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunosuppression | — | UNRESOLVED | — |
| Radiofrequency Ablation | — | UNRESOLVED | — |
| Tumor Immunity | Hepatocellular Carcinoma | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiofrequency ablation | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RFA plus carrizumab
- interventionNames
- Combination Product: radiofrequency ablation
- type
- PLACEBO_COMPARATOR
- label
- carrizumab
- interventionNames
- Combination Product: radiofrequency ablation
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- through study completion, an average of 4 years
- description
- Time from patients received treatment fist time to disease progress or death
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.