Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors

Last updated: June 23, 2024
Sponsor: Second Affiliated Hospital of Guangzhou Medical University
Overall Status: Active - Recruiting

Phase

1/2

Condition

Gastric Cancer

Breast Cancer

Head And Neck Cancer

Treatment

ipilimumab +pembrolizumab +durvalumab

Clinical Study ID

NCT05187338
ZZICI3-015
  • Ages 18-70
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 ≤ 145.5umul/L；Albumin > 28 g/L；Total bilirubin < 51 μmol/L

  7. At least one tumor lesion meeting measurable disease criteria as determined byRECIST v1.1.

  8. Birth control.

  9. Willing and able to comply with scheduled visits, treatment plan and laboratorytests.

Exclusion

Exclusion Criteria:

  1. Patients participated in clinical trials of equipment or drugs (signed informedconsent) within 4 weeks;

  2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastricvarices bleeding;

  3. Any serious accompanying disease, which is expected to have an unknown, impact onthe prognosis, include heart disease, inadequately controlled diabetes andpsychiatric 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 adoptappropriate 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.Knownsevere 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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: ipilimumab +pembrolizumab +durvalumab
Phase: 1/2
Study Start date:
November 01, 2021
Estimated Completion Date:
October 30, 2035

Study 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.

Connect with a study center

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510260
    China

    Active - Recruiting

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