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Infusion of Toripalimab Via Neck Artery Versus Vein for Immunotherapy of Head/Neck Cancers (HNC)

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ClinicalTrials.gov Identifier: NCT03952065
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Guangzhou Medical University

Brief Summary:
This trial was designed to investigate the survival outcomes, response rates, and safety of patients with advanced Head/Neck Squamous cancer by neck artery versus vein infusion of Toripalimab.

Condition or disease Intervention/treatment Phase
Head/Neck Neoplasm Drug: Toripalimab Phase 3

Detailed Description:

Head/Neck cancer is a kind of hard-to-treat malignancy worldwide and its overall survival rate is still low. Toripalimab is a PD1 monoclonal antibody approved to treat Hodgkin's lymphoma in China since 2018. The neck arterial chemotherapy infusion for advanced HNC, through the "first pass effect" of drug treatment, can significantly increase the local drug concentration of the tumor, improve the efficacy, reduce systemic adverse reactions.

To the investigator's knowledge, no studies have been developed on the survival benefit of neck artery infusion of immunotherapeutic agents in patients with advanced HNC. This phase III clinical trial was designed to compare the effects of Toripalimab via IA and IV on the survival benefit of patients with advanced HNC, including ORR, DCR, median survival time, and safety.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Comparison of Survival Benefit of Administration of Toripalimab Via Neck Artery Versus Vein Infusion for Immunotherapy of HNC
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Arm Intervention/treatment
Experimental: Toripalimab infusion via neck artery Drug: Toripalimab
Infusion of Toripalimab through peripheral vein or neck artery.

Experimental: Toripalimab infusion via peripheral vein Drug: Toripalimab
Infusion of Toripalimab through peripheral vein or neck artery.




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]
    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.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2 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 mRECIST) 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.

  2. Adverse event rate [ Time Frame: 2 years ]
    Adverse event rate will be defined as the rate of patients who developed adverse event.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cytohistological confirmation is required for diagnosis of HNC.
  2. Signed informed consent before recruiting.
  3. Age between 18 to 80 years with estimated survival over 3 months.
  4. 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. Patients with advanced HNC which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection and other treatment.
  9. Birth control.
  10. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

Exclusion Criteria:

  1. Patients participated in other clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
  2. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
  3. Patients accompanied with other tumors or past medical history of malignancy;
  4. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
  5. Patients have poor compliance.

    Any contraindications for neck artery 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).

  6. Allergic to adriamycin chemotherapy drugs,contrast agent or lipiodol;
  7. Any agents which could affect the absorption or pharmacokinetics of the study drugs
  8. Subjects unable to suffer the discomfort of the artery infusion procedure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952065


Contacts
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Contact: Hui Lian, MD 02034153532 lian-hui-2008@163.com
Contact: Hui Lian, PhD 02034153532 lian-hui-2008@163.com

Locations
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China, Guangdong
The Second Affiliated Hospital of Guangzhou Medical University Recruiting
Guanzhou, Guangdong, China, 510260
Contact: Hui Lian, MD,PhD    02034153532    lian-hui-2008@163.com   
Sponsors and Collaborators
Second Affiliated Hospital of Guangzhou Medical University

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Responsible Party: Second Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03952065     History of Changes
Other Study ID Numbers: Artery Toripalimab for HNC
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Second Affiliated Hospital of Guangzhou Medical University:
Head/Neck tumor
PD1 antibody
Artery infusion

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms