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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

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date May 16, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • 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.
  • Adverse event rate [ Time Frame: 2 years ]
    Adverse event rate will be defined as the rate of patients who developed adverse event.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Infusion of Toripalimab Via Neck Artery Versus Vein for Immunotherapy of Head/Neck Cancers (HNC)
Official Title  ICMJE A Phase III Randomized Trial of Comparison of Survival Benefit of Administration of Toripalimab Via Neck Artery Versus Vein Infusion for Immunotherapy of HNC
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head/Neck Neoplasm
Intervention  ICMJE Drug: Toripalimab
Infusion of Toripalimab through peripheral vein or neck artery.
Study Arms  ICMJE
  • Experimental: Toripalimab infusion via neck artery
    Intervention: Drug: Toripalimab
  • Experimental: Toripalimab infusion via peripheral vein
    Intervention: Drug: Toripalimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hui Lian, MD 02034153532 lian-hui-2008@163.com
Contact: Hui Lian, PhD 02034153532 lian-hui-2008@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952065
Other Study ID Numbers  ICMJE Artery Toripalimab for HNC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Second Affiliated Hospital of Guangzhou Medical University
Study Sponsor  ICMJE Second Affiliated Hospital of Guangzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Second Affiliated Hospital of Guangzhou Medical University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP