NCT06492408 Neoadjuvant Intra-tumor Double Immunotherapy for Hepatocellular Carcinoma.
| NCT ID | NCT06492408 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Hepatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 90 participants in total. It began in 2024-07-01 with a primary completion date of 2028-12-30.
⚠ 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
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.
Eligibility Criteria
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.
Contact & Investigator
Zhenfeng Zhang, MD, PhD
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital of Guangzhou Medical University
Frequently Asked Questions
Who can join the NCT06492408 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatic Cancer. 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 NCT06492408 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 NCT06492408 currently recruiting?
Yes, NCT06492408 is actively recruiting participants. Contact the research team at zhangzhf@gzhmu.edu.cn for enrollment information.
Where is the NCT06492408 trial being conducted?
This trial is being conducted at Guanzhou, China.
Who is sponsoring the NCT06492408 clinical trial?
NCT06492408 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The principal investigator is Zhenfeng Zhang, MD, PhD at Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 90 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.