Trial Title:
Camrelizumab Plus Docetaxel and Cisplatin in Recurrent or Metastatic Oral Squamous Cell Carcinoma Patients
NCT ID:
NCT05611463
Condition:
Oral Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Docetaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab Plus Docetaxel and Cisplatin
Description:
Camrelizumab (200 mg) was administered once on day 1 every 3 weeks until disease
progression, intolerable toxicity, physician or participant decision or 35 cycles,
whichever occurred first. Chemotherapy was received docetaxel (75 mg/m2) and cisplatin
(75 mg/m²) on day 2 every 3 weeks for six cycles.
Arm group label:
Camrelizumab Plus Docetaxel and Cisplatin
Other name:
SHR-1210+DTX+Platinol
Summary:
the purpose of this study is to assess the efficacy and safety of camrelizumab plus
Docetaxel and Cisplatin as First-line Therapy in Recurrent or Metastatic Oral Squamous
Cell Carcinoma Patients
Detailed description:
Head and neck cancer is the sixth most common cancer in the world, with more than 550,000
cases and 300,000 deaths worldwide each year. About 75,000 Chinese suffer from head and
neck cancer each year, and currently, there are a total of 176,000 patients with head and
neck cancer in China. More than 95% of head and neck cancers are squamous cell
carcinomas, and head and neck squamous cell carcinoma (SCCHN) disrupts and affects the
patient's appearance and basic physiological functions, sensory functions, and language
functions, thus affecting the patient's quality of life. Most head and neck squamous cell
carcinomas are incurable, and they will develop local recurrence and metastasis.
More than 60% of patients with head and neck squamous cell carcinoma have stage III or IV
disease characterized by large size tumors with marked local invasion, evidence of
metastasis to regional lymph nodes, or both. Locally advanced head and neck cancer has a
high risk of local recurrence and distant metastasis and a poor prognosis. Over the past
20 years, multimodal treatment approaches have steadily improved cure rates while
striving to maintain patient function and quality of life.
This clinical study involved Recombinant Humanized Anti-PD-1 Monoclonal Antibody
Injection (Camrelizumab), a Class 1 new therapeutic biological product developed by
Jiangsu Hengrui Medicine Co., Ltd., which was approved by NMPA in May 2019 for the
treatment of relapsed or refractory classical Hodgkin's lymphoma, by NMPA in March 2020
for the treatment of patients with advanced hepatocellular carcinoma who have received
sorafenib and/or oxaliplatin-based systemic chemotherapy, and in June 2020 for the
second-line treatment of esophageal squamous cell carcinoma and first-line treatment of
non-squamous non-small cell lung cancer.
Preclinical study data showed that camrelizumab had comparable in vivo efficacy and
safety compared with similar drugs abroad. Since 2015, Hengrui has simultaneously carried
out a number of phase I/II clinical trials in Australia and China to preliminarily verify
the safety, tolerability and efficacy of camreibizumab in the treatment of advanced solid
tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with histologically confirmed post-surgical recurrent/metastatic or locally
advanced inoperable oral squamous carcinoma with measurable lesions (spiral CT scan
≥ 10 mm, meeting RECIST 1.1 criteria).
- No prior treatment with any systemic antineoplastic agent, prior adjuvant or
neoadjuvant therapy (other than PD-1/PDL-1 monoclonal antibody) is allowed, provided
that it was completed at least 4 weeks prior to the first dose of study drug and all
associated toxic events have returned to normal or to grade I or below as defined by
CTCAE 4.03 classification.
- An ECOG score of 0 or 1.
- Expected survival of ≥ 12 weeks.
- Normal function of major organs within 2 weeks prior to treatment, i.e. meeting the
following criteria.
Bone marrow function: hemoglobin ≥ 100gg/L, white blood cell count ≥ 4.0*10^9/L or
neutrophil count ≥ 2.0*10^9/L and platelet count ≥ 100*10^9/L without transfusion or with
colony-stimulating factor support therapy.
Liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, aspartate
aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1.5 times the upper limit of
normal.
Renal: blood creatinine level less than 1.5 times the upper limit of normal or creatinine
clearance ≥ 60 ml/min and urea nitrogen ≤ 200 mg/L. Urine protein <+, if urine protein +
then total 24 hour protein must be <500mg.
Blood glucose: within normal range and/or with diabetic patients on treatment but with
stable blood glucose control.
Pulmonary function: baseline FEV1 of at least 2L, if baseline FEV1 < 2L, FEV1 >800ml is
expected after surgery as assessed by a surgical specialist.
Cardiac function: no myocardial infarction within 1 year; no unstable angina; no
symptomatic severe arrhythmia; no cardiac insufficiency.
- Women of childbearing potential must have a negative serum pregnancy test result
within 7 days prior to the first dose of the test drug; men of childbearing
potential or women of childbearing potential must use a highly effective
contraceptive method (e.g., oral contraceptive pill, intrauterine device, abstinence
from sexual intercourse, or barrier contraceptive method combined with spermicide)
throughout the trial and continue to use contraception for 12 months after the end
of treatment.
Exclusion Criteria:
- Patients with prior anti-PD-1, anti-PD-L1, anti-PD-L2 therapy. Patients who are
currently receiving antineoplastic therapy.
- Patients who have participated or are participating in a clinical trial of another
drug/therapy within 4 weeks prior to the first dose of the study drug.
- Patients with any active autoimmune disease or history of autoimmune disease (e.g.,
the following, but not limited to: autoimmune hepatitis, interstitial pneumonia,
uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis,
hyperthyroidism; patients with vitiligo; asthma that has completely resolved in
childhood and does not require any intervention in adulthood may be included;
patients who require medical intervention with bronchodilators (asthma, on the other
hand, cannot be included).
- Patients who are on immunosuppressive, or systemic hormone therapy for
immunosuppressive purposes (doses >10 mg/day prednisone or other equipotent hormone)
and are continuing to use them within 2 weeks prior to enrollment.
- Patients who have received hematopoietic stimulating factors, such as granulocyte
colony-stimulating factor (G-CSF), erythropoietin, etc., within 1 week prior to the
first administration of the study drug.
- Positive test results for HIV antibodies or syphilis spirochete antibodies. Patients
with active hepatitis B or C:
- If HBsAg or HBcAb is positive, add HBV DNA test (the result is higher than the upper
limit of the normal range).
- Additional HCV RNA testing if positive for HCV antibodies (results above the upper
limit of the normal range).
- Persons with known hypersensitivity to recombinant humanized PD-1 monoclonal
antibody drugs and their components.
- Massive pleural or ascites fluid with clinical symptoms and requiring symptomatic
management.
- Active lung disease (interstitial pneumonia, pneumonia, obstructive lung disease,
asthma) or a history of active tuberculosis.
- Have any clinical problems beyond their control, including but not limited to:
Persistent or active (severe) infection;
- Poorly controlled diabetes;
- Cardiac disease (Class III/IV congestive heart failure or heart block as defined by
the New York Heart Association);
- Have or suspect autoimmune disease, or a history of autoimmune disease or syndrome
requiring steroid/immunosuppressive systemic therapy, such as: hypopituitaritis,
colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;
- Deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or
unstable arrhythmia or angina; percutaneous coronary intervention, acute coronary
syndrome, coronary artery bypass grafting; cerebrovascular accident, transient
ischemic attack, cerebral embolism within 6 months prior to first dose.
- Abnormal coagulation (INR > 2.0, PT > 16s), with bleeding tendency or on
thrombolytic or anticoagulant therapy, allowing prophylactic use of low-dose
aspirin, low-molecular heparin.
- Those who had clinically significant bleeding symptoms or clear bleeding tendency
within 3 months prior to randomization, such as daily cough/hemoptysis of 2.5 ml or
more, gastrointestinal bleeding, esophagogastric fundic varices at risk of bleeding,
bleeding gastric ulcers or suffering from vasculitis, etc., may be reviewed if the
fecal occult blood is positive at baseline, and if it is still positive after
review, gastroscopy is required, and if gastroscopy indicates severe esophagogastric
fundic varices cannot be enrolled (except for those who underwent gastroscopy 3
months or less before enrollment to exclude such conditions).
- Known presence of hereditary or acquired bleeding and thrombotic tendencies (e.g.,
hemophiliacs, coagulation disorders, thrombocytopenia, etc.)
- Have received a stem cell transplant or organ transplant.
- Those with a history of psychotropic substance abuse and unable to abstain or a
history of mental disorders.
- Other serious, acute or chronic medical conditions or laboratory test abnormalities
that, in the judgment of the investigator, may increase the risk associated with
participation in the study, or may interfere with the interpretation of study
results.
- The patient had a history of other malignancies within five years.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200011
Country:
China
Status:
Recruiting
Contact:
Last name:
Guoxin Ren, PHD
Phone:
021-23271699
Email:
renguoxincn@sina.com
Start date:
June 2, 2020
Completion date:
June 2, 2023
Lead sponsor:
Agency:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Agency class:
Other
Source:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05611463
