Second Affiliated Hospital of Guangzhou Medical University
Phase
Phase 2
Started
2024-06-10
Last updated
2024-07-01
Condition(s) studied
Liver CancerAntibody
Investigational drug(s) / intervention(s)
ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab
ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab: This study has 3 subgroups:
Arm 1. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab is administrated with a total dose of 1-2mg/kg via intra-tumor fine needle injection in 10 min, every 3 weeks.
Arm 2. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin is administrated via intra-tumor fine needle injection in 15 min, every 3 weeks.
Arm 3. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin plus bevacizumab is administrated via intra-tumor fine needle injection in 20 min, every 3 weeks.
Study summary
This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through intra-tumor (IT).
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety of IT delivery of drugs combination treatment — 5 years Safety will be assessed by recording all types of advise effects upon and after the treatment.
Progression-free survival — 5 years Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.
Disease control rate — 5 years Disease control rate will be defined as objective response rate + steady disease rate.
Duration of remission (DOR) — 5 years DOR will be defined as the duration of the cancer remission.
Trial sites (1)
Facility
City
Region
Status
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou
China
Recruiting
More Second Affiliated Hospital of Guangzhou Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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