Neoadjuvant immunotherapy for liver cancer
Phase II Study of Neoadjuvant CT-Guided Intra-tumor Double Checkpoint Blockades for Untreated Hepatocellular Carcinoma (HCC) Amenable for Surgical Resection
This study is testing a new way to deliver immunotherapy directly into liver tumors to see if it helps patients with liver cancer feel better and have better treatment results before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | ipilimumab, pembrolizumab, durvalumab, bevacizumab |
| Locations | 1 site (Guanzhou, Guangdong) |
| Trial ID | NCT06492408 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and effectiveness of a combination of immunotherapy drugs, specifically CTLA4 and PD1 or PDL1 antibodies, delivered directly into tumors of patients with hepatocellular carcinoma (HCC). The approach utilizes CT-guided intra-tumor injections to enhance local drug concentration, potentially improving treatment outcomes while minimizing systemic side effects. The study aims to assess various outcomes, including safety, pathological complete response, progression-free survival, and overall response rates. This phase II trial is particularly focused on patients who are candidates for surgery and have not received prior treatment for their HCC.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed, previously untreated hepatocellular carcinoma who are suitable for surgical intervention.
Not a fit: Patients with advanced liver disease or those who are not candidates for surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and reduce side effects for patients with hepatocellular carcinoma.
How similar studies have performed: While similar immunotherapy approaches have shown success in other cancers, this specific method of intra-tumor delivery for hepatocellular carcinoma is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guanzhou, Guangdong
- The Second Affiliated Hospital of Guangzhou Medical University — Guanzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Zhenfeng Zhang, MD, PhD — Second Affiliated Hospital of Guangzhou Medical University
- Study coordinator: Zhenfeng Zhang, MD, PhD
- Email: zhangzhf@gzhmu.edu.cn
- Phone: +862039195966
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.