Overview
Study of Camrelizumab in Combination With Apatinib Mesylate Plus Albumin-bound Paclitaxel and Cisplatin as the First Line Treatment of Recurrent or Metastatic, UnresectableHead and Neck Squamous Cell Carcinoma
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2025-03-30
2025-03-30
Target enrollment:
0
0
Participant gender:
All
All
Summary
This is a prospective, open-labelled study to evaluate the efficacy and safety of Camrelizumab in Combination With Apatinib mesylate Plus Albumin-bound paclitaxel and cisplatin as the First Line Treatment of Metastatic or Recurrent, UnresectableHead and Neck Squamous Cell Carcinoma. The objective response rate (ORR) will be evaluated as the primary endpoints.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
The First Affiliated Hospital of Zhengzhou UniversityCollaborator:
Jiangsu HengRui Medicine Co., Ltd.Treatments:
Albumin-Bound Paclitaxel
Apatinib
Paclitaxel
Criteria
Inclusion Criteria:1、Has fully understood and voluntarily signed an written Informed Consent and agreed to
follow the research plan treatment and visiting plan; 2、Aged >=18 years; 3、Histologically
confirmed recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and/or
larynx that is considered incurable by local therapies; 4、Eastern Cooperative Oncology
Group (ECOG) performance status 0-1; 5、Expected survival period ≥ 3 months; 6、Tumor tissue
with PD-L1 detection (paraffin specimens or fresh tumor tissue within 2 years) can be
provided or PD-L1 test report of tumor tissue samples issued by a state-approved
qualification unit; 7、At least one measurable lesion, according to RECIST 1.1; 8、Toxicity
of the subject has been restored to the ≤1 level defined by NCI-CTCAE V5.0 (except hair
loss); 9、Patients must be able to swallow oral drugs and do not have significant affected
gastrointestinal abnormalities, such as absorption adverse syndrome or most of the
gastrointestinal tract; 10、The main function is normal, the test results at the time of
screening must meet the following requirements:
1. Blood routine (no blood transfusion, erythropoietin (EPO),
granulocyte-colony-stimulating factor (G-CSF) or
granulocyte-macrophage-colony-stimulating factor (GM-CSF) within 14 days prior to
screening) :
A.Hemoglobin (HB) ≥ 90 g / L; B.Absolute neutrophil count (ANC) of >= 1.5*10^9/L;
C.platelet count of >= 100*10^9/L;
2. Biochemical examination needs to meet the following criteria:
A.TBIL < 1.5 ULN (Gilbert syndrome patient, < 3 ULN); B.ALT and AST < 3 ULN, if there
exists hepatic metastases, ALT and AST < 5 ULN; C.Cr <=1.5 ULN or CCr ≥50ml/min;
3. Echocardiography:LVEF≥50%;
4. INR or PT <= 1.5 ULN, APTT <=1.5 ULN; 11、Contraception: Women of childbearing age
should agree to use effective contraception during the study and for 6 months after
the end of the study; Negative serum or urine pregnancy test within 7 days prior to
study enrollment and must be non-lactating; Men who agreed to use contraception during
the study period and for six months after the end of the study period.
Exclusion Criteria:
1. Those who are allergic to drug treatment;
2. Disease that is suitable for local therapy administered with curative intent;
3. Accept system chemotherapy, but does not include a circulation of a multi-mode
treatment for chemotherapy for local advanced diseases (this treatment end time must
be 6 months from the first test for the first test);
4. Patients with local advanced head and neck squamous cell carcinoma have completed
multi-mode chemotherapy completed within 6 months of disease progression;
5. It has received immunotherapy for anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or
anti-CTLA-4 antibody or targeted to T cell common stimulation or immunoction point
pathway;
6. There have been any malignant tumors in five years, except for other malignant
tumors,cervical in situ cancer, non-melanoma skin cancer or other tumors / cancer that
passively treats for at least 5 years without disease;
7. Anti-blood vessel treatment was received within 6 months before administration;
8. According to NCI CTCAEV5.0, there have been peripheral neuropathy ≥ 2;
9. Accompanied by known active central nervous system transfer (CNS) and / or cancer
meningitis: Previously received brain transfer subjects can participate in research,
premise is the clinical stability for at least 2 weeks, no new or expanded brains
Transfer evidence, and 14 days before the drug administration, steroids were stopped
14 days. The stable brain transfer in this definition should be determined before the
study of drugs for the first time. The invisible brain transfer subject (ie there is
no nervous system symptoms, no corticosteroids, no lesions> 1.5 cm) can participate,
but need to periodically perform brain imaging in the disease site;
10. It has not been recovered from any acute impact of past surgery, chemotherapy or
radiotherapy, ie, the subject of ≤1 (NCI CTCAEV5.0) (except for external hair loss),
if the nutritional state is stable, it is allowed to radiotherapy and / or surgery
Produced chronic advanced toxicity (pharyngeal / throat, namely oral dry, speech,
swallowing abnormal);
11. Within 4 weeks or 4 weeks before the first administration, the anti-tumor drug
treatment (such as chemotherapy, hormone therapy, immunotherapy, antibody treatment,
radiotherapy, etc.), except for reducing pain on bones, except for bones;
12. It has received major surgery within the 4 weeks of the first administration or is
expected to carry out major surgery during this study;
13. In the first 2 weeks or 2 weeks of the first administration, immunosuppressive drugs
is required, and the following is eliminated:
1. intranasal, inhalation, external use steroids or local steroid injection (such as
joint internal injection);
2. physiological doses of systemic corticosteroids (≤10 mg / connone or equivalent
dose);
3. A short-term (≤7 days) use steroids to prevent or treat non-autoimmune allergic
diseases; 14.、Subjects that are known to have active, or have a medical history
and may relapse (such as systemic lupus erythematosus, rheumatoid arthritis,
inflammatory bowel disease, autoimmune thyroid disease, Patients with multiple
hardening, vascular, glomerulitis, etc.), or high risk (such as receiving organ
transplantation require immunotherapy). However, the following patients are
allowed to be incorporated: patients with type I diabetic patients with fixed
doses; only the autoimmune thyroid dysfunction of hormone replacement treatment;
skin disease (such as eczema, occupancy) without systemic treatment 10% or less
ramp, no opaque symptoms of psoriasis, etc.); 15、15. There is a significant
clinical cardiovascular disease, including but not limited to acute myocardial
infarction within 6 months of the group, severe / unstable angina or coronary and
bridge; congestive heart failure New York Heart Association (NYHA) ≥ 2 Level;
arrhythmia (including QTC inter-male male ≥ 450 ms, female ≥ 470 ms); left
ventricular ejection fraction (LVEF) <50%;
16、Under anti-hypertension treatment, still uncontrolled hypertension, defined as: systolic
blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg; 17、Urinalysis shows urine
protein ≥2+ or 24-hour protein quantity test shows urinary protein ≥1 g; 18、History of
mental drug abuse and unable to quit or have mental disabilities; 19、Active or uncontrolled
severe infection; 20、It is known that there is a history of liver disease, including but
not limited to known moonitis virus (HBV) infection and HBV DNA positive (≥1 × 104 copy /
ml); Hepatitis Hepatitis Virus infection (HCV) and HCV RNA positive (≥1 × 103copy / ml), or
cirrhosis, etc .; 21、Patients with pulmonary fibrosis, interstitial pneumonia, dust lung,
radioactive pneumonia, drug-based pneumonia and severe lung function; 22、Pregnancy
(pregnancy detection of pregnancy) or women underwater; 23、The first use of medication
within 30 days or expected to vaccinate the vaccination during the study; 24、Subjects have
or plans to receive physical organs or blood system transplants during the study (except
corneal transplantation); 25、According to the judgment of the researcher, it is considered
that it is not suitable for the group.