Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Oct 30, 2025
  • participants needed
    100
  • sponsor
    Second Affiliated Hospital of Guangzhou Medical University
Updated on 25 March 2022
cancer
total bilirubin
measurable disease
pembrolizumab
ipilimumab
durvalumab

Summary

This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by infusion of CTLA4, PD1 and PDL1 antibodies combination through venous (IV), artery (IA) or intra-tumor (IT).

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 cancer 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 therapeutic efficiency is still low. It is very difficult to treat patients with recurrent/refractory/metastatic advanced solid cancers and more alternative therapies are urgently needed.

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, PD1 antibody and PDL1 antibody, so called triplex checkpoint inhibitors combination therapy, for advanced solid tumors. To the investigator's knowledge, no studies have been developed on the safety, efficacy and survival benefit of the triplex checkpoint inhibitors combination therapy for cancer patients. This phase I-II clinical trial is designed to assess the safety and survival benefit of ipilimumab, pembrolizumab and durvalumab combination on patients with advanced solid cancers, including PFS, ORR, DCR, and median survival time.

Details
Condition Lung Cancer, Liver Cancer, Colorectal Cancer, Pancreas Cancer, Ovary Cancer, Head and Neck Cancer, Breast Cancer, Gastric Cancer, Cervical Cancer, Esophageal Cancer, Sarcoma
Treatment ipilimumab +pembrolizumab +durvalumab
Clinical Study IdentifierNCT05187338
SponsorSecond Affiliated Hospital of Guangzhou Medical University
Last Modified on25 March 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: 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
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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