Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors for Immunotherapy of Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Nov 1, 2033
  • participants needed
    200
  • sponsor
    Second Affiliated Hospital of Guangzhou Medical University
Updated on 1 February 2022
cancer
total bilirubin
measurable disease
pembrolizumab
ipilimumab
solid tumors
solid tumour

Summary

This trial was designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by trans-artery/intra-tumor infusion of PD1/PDL1 antibody and/or CTLA4 antibody ipilimumab and to compare their differences.

Description

Malignant solid tumors including lung and liver cancers are the most common malignancy worldwide, and their mortality rates are very high. China has a huge population base, with about 4,000,000 new cases each year. More than 60% of the solid tumors in China are diagnosed at mid-to-late stage and have lost the chance of surgery. Recently a lot of therapeutic strategies have been developed and applied to clinic including targeted therapy and immunotherapy, but the overall efficiency is still low. It is difficult to be widely used in patients with advanced solid cancers, and more alternative therapies are urgently needed.

Antibodies against PD1, PDL1 and CTLA4 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, through so called "first pass effect" of drug on target organs. To the investigator's knowledge, no studies have been developed on the efficacy and survival benefit of localized delivery of checkpoint inhibitors for treatment of cancer patients. This phase II-III clinical trial was designed to compare the effects of Pembrolizumab, Tecentriq, et al and/or ipilimumab on the survival benefit of patients with advanced solid cancers, including ORR, DCR, median survival time, and safety.

Details
Condition Hepatocarcinoma, Lung Cancer, Melanoma, Renal Cancer, Head and Neck Cancer, Pancreas Cancer, Ovarian Cancer, Colo-rectal Cancer, Cervical Cancer, Breast Cancer
Treatment Pembrolizumab, Checkpoint inhibitor (CPI) such as Pembrolizumab
Clinical Study IdentifierNCT03755739
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Last Modified on1 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cytohistological confirmation is required for diagnosis of cancer
Signed informed consent before recruiting
Age above 18 years with estimated survival over 3 months
Child-Pugh class A or B/Child score > 7; ECOG score < 2
Tolerable coagulation function or reversible coagulation disorders
Laboratory examination test within 7 days prior to procedure: WBC3.010E9/L; Hb90g/L PLT 5010E9/LINR < 2.3 or PT < 6 seconds above controlCr 145.5 umul/LAlbumin > 28 g/LTotal bilirubin < 51 mol/L
At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1
Birth control
Willing and able to comply with scheduled visits, treatment plan and laboratory tests

Exclusion Criteria

Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks
Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding
Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders
Patients accompanied with other tumors or past medical history of malignancy
Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment
Patients have poor compliance
Any contraindications for hepatic arterial infusion procedure
A.Impaired clotting test (platelet count < 60000/mm3, prothrombin activity <
%)
B.Renal failure / insufficiency requiring hemo-or peritoneal dialysis. C.Known
severe atheromatosis. D.Known uncontrolled blood hypertension (> 160/100
mm/Hg)
\. Allergic to contrast agent
\. Any agents which could affect the absorption or pharmacokinetics of the
study drugs
\. Other conditions that investigator decides not suitable for the trial
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