Clinical trial · Interventional
Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.
Phase II Study of Neoadjuvant CT-Guided Intra-tumor Double Checkpoint Blockades for Untreated Hepatocellular Carcinoma (HCC) Amenable for Surgical Resection
NCT06492408CI-TRIAL-00078684recruitingPhase 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)
This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by delivery of CTLA4 and PD1 or PDL1 antibodies combination through CT-guided intra-tumor (IT) injection.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Cancer | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Group 1: IT injection of double ICIs
- description
- Neoadjuvant therapy: intra-tumor injection of double ICIs only.
- interventionNames
- Drug: ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab
- type
- EXPERIMENTAL
- label
- Group 2: IT injection of double ICIs and chemodrug
- description
- Neoadjuvant therapy: intra-tumor injection of double ICIs and chemodrug.
- interventionNames
- Drug: ipilimumab, pembrolizumab, durvalumab, idarubicin, bevacizumab
- type
- EXPERIMENTAL
- label
- Group 3: IT injection of double ICIs and chemodrug plus bevacizumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed previously untreated hepatocellular carcinoma (HCC). If a diagnostic biopsy is available, a pre-treatment biopsy is not required. Patients with a suspected HCC are eligible, but pathology must be confirmed prior to initiating treatment on study. 2. The patient must be a suitable candidate for surgery, in the opinion of the treating physician. 3. Signed and dated written informed consent must be provided by the patient prior to admission to the study in accordance with International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and to the local legislation. 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1 5. Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L; Hemoglobin \>= 8.0 g/dL; Platelets \>= 100 x 10\^9/L; Total bilirubin =\< 1.5 x upper limit of normal (ULN) (except subjects with Gilbert syndrome who can have total bilirubin \< 3.0 mg/dL); Creatinine =\< 1.5 x ULN or calculated creatinine clearance \>= 50 mL/min using Cockcroft-Gault formula for creatinine clearance calculation OR 24-hour urine creatinine clearance \>= 50 mL/min. 6. Birth control. 7. Willing and able to comply with scheduled visits, treatment plan and laboratory tests. Exclusion Criteria: 1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks; 2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding; 3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders; 4. Patients accompanied with other tumors or past medical history of malignancy; 5. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment; 6. Patients have poor compliance. A.Impaired clotting test (platelet count \< 60000/mm3, prothrombin activity \< 50%). B.Renal failure / insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (\> 160/100 mm/Hg). 7. Allergic to contrast agent; 8. Any agents which could affect the absorption or pharmacokinetics of the study drugs 9. Other conditions that investigator decides not suitable for the trial.
References
Publications (0)
Data not yet available
No reference posted for this study.