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Trial Title:
Toripalimab Maintenance for Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT ID:
NCT05773079
Condition:
Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
Squamous Cell Carcinoma of Head and Neck
Toripalimab
PFS
Immunotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Within 4 to 12 weeks after the first line of treatment, the maintenance treatment of
Toripalimab was started, and 240 mg of Toripalimab was injected intravenously every 3
weeks (the maintenance treatment time was not more than 1 year, until there was an
intolerable toxic reaction, or disease progression, or withdrawal of consent, or the
investigator judged that it was necessary to withdraw from the treatment, or the subject
had received treprizumab treatment for a cumulative period of 1 year or other reasons
specified in the protocol). During the treatment period, tumor imaging evaluation shall
be conducted every 3 months to see the research process description for details, and the
evaluation shall be conducted according to the evaluation criteria of recist. If the
evaluation is progress, the treatment shall be stopped.
Arm group label:
Toripalimab
Summary:
The guidelines for locally advanced head and neck squamous cell carcinoma currently
recommend surgery / radiotherapy / chemotherapy / targeted therapy. However, the median
PFS of patients with high risk factors after comprehensive treatment was about 17 months,
and the 2-year PFS rate was about 40 %. The KEYNOTE-048 study showed that PD-1 monoclonal
antibody alone or in combination with chemotherapy significantly improved survival and
was safe for recurrent / metastatic head and neck squamous cell carcinoma. Therefore,
PD-1 monoclonal antibody has become the first-line treatment of metastatic head and neck
squamous cell carcinoma. For locally advanced head and neck squamous cell carcinoma, the
existing studies on immunotherapy for neoadjuvant or concurrent chemoradiotherapy have
not been clearly concluded. We previously used PD-1 monoclonal antibody for the
maintenance treatment of patients after the first-line treatment of locally advanced head
and neck squamous cell carcinoma, without residual tumor, which showed a trend of
prolonged survival. Therefore, this study intends to explore whether the maintenance
treatment of PD-1 monoclonal antibody terripril can further improve the survival of
patients with locally advanced head and neck squamous cell carcinoma with high risk
factors and no residual tumor after first-line comprehensive treatment, and the safety is
good.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Locally advanced squamous cell carcinoma of the head and neck (AJCC8thIII-IV)
confirmed by pathology in the initial treatment;
- No residual lesions after first-line surgery/radiotherapy/chemotherapy/targeted
comprehensive treatment;
- Associated high risk factors: T3-4, regional lymph node positive, vascular invasion,
neural invasion, lymph node capsular invasion, incisional margin positive;
- The patients' age is between 18 and 70 years old;
- The ECOG physical fitness status score is 0 or 1;
- Estimated survival period ≥ 3 months;
- The main organ functions meet the following standards: (1) Blood routine (without
blood transfusion within 14 days): HGB ≥ 110g /L, WBC ≥ 3.0 × 10^9\/L， NEUT≥1.5 ×
10^9\/L，PLT ≥75 × 10^9\/L； (2) Biochemical: BIL ≤ 1.5 times the upper limit of
normal value (ULN), ALT and AST ≤ 2.0 × ULN, serum Cr ≤ 1.5 × ULN or endogenous
creatinine clearance ≥ 50ml /min; (3) Occult blood in stool (-); (4) Normal urine
routine, or urine protein<(++), or 24-hour urine protein<1.0g; (5) Left
ventricular ejection fraction (LVEF) ≥ 50%. (6) The blood coagulation function is
normal, and there is no active bleeding or thrombosis disease. A. International
standardized ratio INR ≤ 1.5 × ULN； B. Partial thromboplastin time APTT ≤ 1.5 × ULN；
C. Prothrombin time PT ≤ 1.5ULN. (7) Thyroid stimulating hormone (TSH) ≤ 1.5ULN; If
the T3 and T4 levels are abnormal, they should be investigated. If the T3 and T4
levels are normal, they can be selected;
- Women of childbearing age should agree to use contraceptives (such as intrauterine
devices, birth control pills, or condoms) during and within 3 months after the end
of medication; "Within 7 days prior to study enrollment, the serum or urine
pregnancy test was negative and must be a non lactating patient. The male should
agree to use contraception during the study period and within 3 months after the end
of the study period;
- Patients with hepatitis B virus (HBV) infection, inactive/asymptomatic HBV carriers,
or patients with chronic or active HBV who received antiviral therapy for>1 week
at the time of screening are allowed to be enrolled and continue treatment for more
than 6 months after the study drug treatment. Patients with positive hepatitis C
antibodies who have started anti hepatitis C virus treatment at the time of
screening will be allowed to participate in the group;
- Subjects voluntarily joined the study, signed an informed consent form, had good
compliance, and cooperated with follow-up.
Exclusion Criteria:
- Distant metastasis of the tumor was detected upon enrollment;
- Have a history of allergy to PD-1 monoclonal antibody or drug components;
- There has been a history of other malignant tumors within the past 5 years or at the
same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ,
and thyroid papillary carcinoma;
- Uncontrolled clinical cardiac symptoms or diseases, such as: (1) heart failure above
NYHA class II; (2) unstable angina; (3) myocardial infarction within 1 year; (4)
patients with clinically significant supraventricular or ventricular arrhythmias
requiring clinical intervention;
- Have received any of the following treatments: a. Have previously received treatment
with immunosuppressive drugs; B. Have received any investigational drug within 4
weeks before the first use of the investigational drug; C. Joining another clinical
study at the same time, unless it is an observational (non intervention) clinical
study or an intervention clinical study follow-up; D. Subjects who require systemic
treatment with corticosteroids (greater than 10 mg prednisone equivalent dose per
day) or other immunosuppressants within 2 weeks prior to the first use of the study
drug, excluding the use of corticosteroids for local inflammation and the prevention
of allergies, nausea, and vomiting. In the absence of active autoimmune diseases, it
is allowed to inhale or locally use steroids and adrenal cortical hormone
replacement with a dose greater than 10 mg/day of prednisone; E. Have received an
anti-tumor vaccine or a live vaccine within 4 weeks before the first administration
of the study drug; F. Major surgery or severe trauma requiring removal of the
disease within 4 weeks before the first use of the study drug;
- Serious infections (CTCAE greater than Level 2) occurred within 4 weeks before the
first use of the study drug, such as severe pneumonia, intracranial infection, etc.
that require hospitalization;
- Have a history of active autoimmune diseases and autoimmune diseases, but does not
include autoimmune mediated hypothyroidism treated with stable doses of thyroid
replacement hormone; Type I diabetes with a stable dose of insulin; Patients with
vitiligo or recovered childhood asthma/allergies who do not require any intervention
in adulthood;
- Have a history of immunodeficiency, including HIV testing positive, or have other
acquired or congenital immunodeficiency diseases, or have a history of organ
transplantation and bone marrow transplantation;
- Have a history of interstitial lung disease and non infectious pneumonia;
- Patients who have a history of active pulmonary tuberculosis infection through
medical history or CT examination, or who have a history of active pulmonary
tuberculosis infection within 1 year before enrollment, or who have a history of
active pulmonary tuberculosis infection before 1 year but have not received formal
treatment;
- Subjects with active hepatitis (HBV DNA ≥ 2000 IU /ml or 10000 copies /ml) who have
not been treated, and hepatitis C (hepatitis C antibody positive, and HCV-RNA above
the detection limit of the analytical method) who have not been treated;
- Known history of abuse, alcoholism, and drug abuse of psychotropic substances;
- KPS score<60, intolerance to anti-tumor therapy;
- Pregnant or lactating women;
- Engaging or expected to participate in other clinical studies;
- Researchers believe that it is not suitable for inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
May 2024
Completion date:
June 2028
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05773079
