Combination therapy using checkpoint inhibitors for liver cancer treatment
Intra-tumor Delivery of Double Checkpoint Inhibitors, Chemodrug, and/or Bevacizumab Therapy as First Line for Hepatocellular Carcinoma
This study is testing a new way to treat liver cancer by combining special immune drugs with chemotherapy to see if it helps patients feel better and live longer.
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 | bevacizumab, ipilimumab, pembrolizumab, durvalumab |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT06482801 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and effectiveness of combining CTLA4 and PD1/PDL1 antibodies with chemotherapy or bevacizumab for patients with hepatocellular carcinoma (HCC). The approach involves intra-tumor injection of these agents to enhance local drug concentration and minimize systemic side effects. The study aims to evaluate patient outcomes, including progression-free survival and overall response rates, in a Phase II setting. This is the first trial of its kind focusing on this combination therapy delivered locally for HCC.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with confirmed hepatocellular carcinoma and a Child-Pugh score of A or B.
Not a fit: Patients with severe liver dysfunction, such as ascites or hepatic encephalopathy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and safer option for patients with liver cancer.
How similar studies have performed: While similar checkpoint inhibitor combinations have shown success in other cancers, this specific approach for HCC via intra-tumor delivery is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Cytohistological confirmation is required for diagnosis of cancer. 2. Signed informed consent before recruiting. 3. Age above 18 years with estimated survival over 3 months. 4. Child-Pugh class A or B/Child score \> 7; ECOG score \< 2 5. Tolerable coagulation function or reversible coagulation disorders 6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L； PLT ≥50×10E9/L；INR \< 2.3 or PT \< 6 seconds above control；Cr ≤ 145.5 umul/L；Albumin \> 28 g/L；Total bilirubin \< 51 μmol/L 7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1. 8. Birth control. 9. 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. Any contraindications for hepatic arterial infusion procedure: 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
Guangzhou
- Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, 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.