A Phase 2 interventional study of ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab in Lung Cancer and Inoperable Disease, sponsored by Second Affiliated Hospital of Guangzhou Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Second Affiliated Hospital of Guangzhou Medical University · Phase 2, Interventional, and Treatment
This trial is designed to investigate the safety, response rates and survival outcomes of patients with inoperable lung cancer by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through intra-tumor (IT).
Antibodies against CTLA4, PD1 and PDL1 are representative drugs for the check-points inhibitory agents, and their clinical indications have been approved in various types of tumors, including advanced melanoma, non-small cell lung cancer, renal cell carcinoma, and classical Hodgkin's lymphoma and late recurrent head and neck squamous cell carcinoma patients, et al. Those drugs are regularly systemically administrated by vein infusion, however, local delivery of those drugs via interventional radiology technique including trans-artery or intra-tumor injection may increase the local drug concentration of the tumor, improve the efficacy, and reduce systemic adverse reactions. CTLA4 antibody ipilimumab has been widely effectively using to combine with PD1 or PDL1 antibody and this study is to combine ipilimumab and PD1 antibody or PDL1 antibody, so called double checkpoint inhibitors combination therapy, as first line for inoperable lung cancer via intra-tumor admistration. To the investigator's knowledge, no studies have been developed on the safety, efficacy and survival benefit of the double checkpoint inhibitors combination therapy for cancer patients as first line via intra-tumor delivery.
This phase II clinical trial is designed to assess the safety and survival benefit of ipilimumab and pembrolizumab or durvalumab combination with or without chemodrug or bevacizumab as first line therapy on patients with inoperable lung cancer, including PFS, ORR, DCR, and median survival time.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Second Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 73 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
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).
Arm 1: intra-tumor injection of double ICIs only.
Drug: ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab
Arm 2: intra-tumor injection of double ICIs and a chemodrug.
Drug: ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab
Arm 3: intra-tumor injection of double ICIs, a chemodrug, and bevacizumab.
Drug: 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.
Also known as: Local ICIs.
Safety of IT delivery of drugs combination treatment
Safety will be assessed by recording all types of advise effects upon and after the treatment.
Time frame: 5 years
Progression-free survival
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.
Time frame: 5 years
Disease control rate
Disease control rate will be defined as objective response rate + steady disease rate.
Time frame: 5 years
Duration of remission (DOR)
DOR will be defined as the duration of the cancer remission.
Time frame: 5 years
Overall survival
Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.
Time frame: 5 years
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Second Affiliated Hospital of Guangzhou Medical University