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IMplus: Camrelizumab Combined With Apatinib Mesylate for Head and Neck Squamous Cell Carcinoma

Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04440917
Collaborator
(none)
32
Enrollment
1
Location
1
Arm
41.9
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, open-labelled study to evaluate the efficacy and safety of camrelizumab combined with apatinib mesylate in the induction treatment of patients with locally advanced head and neck squamous cell carcinoma who were judged surgically unresectable or appropriate for non-surgical definitive therapy. The objective response rate (ORR) and safety will be evaluated as the primary endpoints, the 2-year overall survival (OS) rate and progression free survival (PFS) rate will be the second endpoints.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Induction Therapy of Camrelizumab Combined With Apatinib Mesylate for Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma (the IMplus Study)
Actual Study Start Date :
Jun 3, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

Inductive therapy with Camrelizumab and Apatinib

Drug: Camrelizumab
200mg, iv, on day 1, 15, 29, 43
Other Names:
  • Humanized anti-PD-1 inhibitor

    • Drug: Apatinib Mesylate
    250 mg po, qd, 28 days as a cycle, 2 cycles in total
    Other Names:
  • VEGFR inhibitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (CR+PR) [9 weeks]

      Objective Response Rate as defined by RECIST 1.1 after induction therapy followed by definitive chemoradiation. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

    Secondary Outcome Measures

    1. Number of Participants With at Least One Grade 3-4 Toxicity [9 weeks]

      Toxicity will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4

    2. Overall Survival [2 years]

      Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months

    3. Progression-Free Survival [2 years]

      Time to death or progression defined by imaging of target lesions via CT or MRI scan every 3 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologically or cytologically confirmed squamous cell or poorly differentiated or undifferentiated cancer of the head and neck (the primary sites include oral cavity, oropharynx, hypopharynx, larynx, nasal cavity and sinuses);

    2. Clinical stage of III-IVb (AJCC 2018);

    3. Surgically unresectable and/or refuse surgery or appropriate for non-surgical definitive therapy;

    4. Measurable disease;

    5. Eastern cooperative oncology group performance status (ECOG PS) score: 0-1;

    6. Blood routine: white blood cells> 3,000/mm3, hemoglobin> 8g/L, platelets> 80,000/mm3；Liver function: Alanine Transaminase/Aspartate Transaminase <2.5 times the upper limit of normal, bilirubin <1.5 times the upper limit of normal; Renal function: serum creatinine <1.5 times the upper limit of normal;

    7. Sign the informed consent.

    Exclusion Criteria:

    1. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;

    2. Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%;

    3. Has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;

    4. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;

    5. Patients undergoing therapy with other investigational agents;

    6. Women who are pregnant or breastfeeding;

    7. Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Shanghai Shanghai China 200011

    Sponsors and Collaborators

    • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
    ClinicalTrials.gov Identifier:
    NCT04440917
    Other Study ID Numbers:
    • 2020HNRT01
    First Posted:
    Jun 22, 2020
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Squamous Cell
    Squamous Cell Carcinoma of Head and Neck
    Apatinib
    Immune Checkpoint Inhibitors

    Study Results

    No Results Posted as of Feb 2, 2021