Clinical trial · Observational
cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC
Conventional Transarterial Chemoembolization (cTACE) or Transarterial Chemoembolization (DEB-TACE) +HAIC Combined With Regorafenib ± Anti-PD1 Antibody for Unresected Hepatocellular Carcinoma
NCT05025592CI-TRIAL-00053665unknownClinicalTrials.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)
explore the effectiveness and safety of conventional transarterial chemoembolization (cTACE) or transarterial chemoembolization (DEB-TACE) plus hepatic arterial Infusion chemotherapy (HAIC) combined with regorafenib and anti-PD-1 antibody or not for unresected hepatocellular carcinoma (uHCC)
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HCC | — | UNRESOLVED | — |
| Hepatic Arterial Infusion Chemotherapy | — | UNRESOLVED | — |
| Regorafenib | — | UNRESOLVED | — |
| Transarterial Chemoembolization | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cTACE/DEB-TACE-HAIC | Device | — | UNRESOLVED |
| Regorafenib | Drug | Regorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- cTACE/DEB-TACE-HAIC+regorafenib±anti-PD1 antibody
- description
- patients will receive the combination treatment of cTACE/DEB-TACE plus HAIC and combined with regorafenib and anti-PD1 antibody or not. The anti-PD-1 antibody will be used depended on the contraindications or wishes of patients.
- interventionNames
- Drug: Regorafenib
- Device: cTACE/DEB-TACE-HAIC
Primary outcomes (3)
- measure
- Objective response rate, ORR
- timeFrame
- 6 months
- description
- The objective response rate (ORR) was defined as the complete response (CR) rate + the partial response (PR) rate
- measure
- Progression free overall survival,PFS
- timeFrame
- 12 months
- description
- PFS was defined as the interval between the time at which treatment was initiated and intrahepatic tumor and/or extrahepatic tumor progression, symptomatic progression, including massive ascites and liver function that was categorized as Child-Pugh grade C, or death from any cause
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Volunteer to participate and sign the informed consent in writing; 2. Age: 18-75 years old; 3. No gender limit; 4. Unresectable hepatocellular carcinoma with clear pathological diagnosis or clinical diagnosis; 5. Unresectable hepatocellular carcinoma patients who failed first-line treatment (including but not limited to sorafenib, lenvatinib, atezolizumab combined with bevacizumab, etc.); 6. At least one measurable lesion (according to mRECIST criteria) imaging diagnosis time ≤ 21 days from selection; 7. Child-pugh grade A-B7 grade 8. The expected survival period is ≥3 months; 9. General physical condition (ECOG) 0-2; 10. Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥9 g/dL, white blood cells ≥3.0×10\^9/L, neutrophils ≥1.5x 10\^9/L, platelets ≥80x 10\^9/L; liver and kidney functions are normal; (Within 14 days): TBIL≤1.5 times the upper limit of normal; ALT and AST≤5 times the upper limit of normal; creatinine≤1.5 times the upper limit of normal; INR≤1.7 or prolonged PT≤4s. Exclusion Criteria: 1. Those who are currently receiving other effective treatments; 2. Patients who have received regorafenib in the past; 3. Patients who have participated in other clinical trials within 4 weeks before enrollment; 4. Unable to cooperate with cTACE and HAIC treatment; 5. Patients with primary malignant tumors other than hepatocellular carcinoma at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; 6. Clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or a history of myocardial infarction within the past 1 year; 7. Neurological or mental abnormalities that affect cognitive ability, including central nervous system transfer; 8. There were active serious clinical infections (\>grade 2 NCI-CTCAE version 4.0), including active tuberculosis within 14 days before enrollment; 9. Known or self-reported HIV infection; 10. Uncontrolled systemic diseases, such as poorly controlled diabetes; 11. Known to have hypersensitivity or allergic reactions to any component of the study drug; 12. Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding
References
Publications (0)
Data not yet available
No reference posted for this study.