Trial Title:
Neoadjuvant Anti-PD-1 Immunotherapy With Chemotherapy in Resectable Locally Advanced Oral Squamous Cell Carcinoma
NCT ID:
NCT05798793
Condition:
Oral Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Cisplatin
Docetaxel
Conditions: Keywords:
Neoadjuvant
Oral squamous cell carcinoma
Anti-PD-1 immunotherapy
Camrelizumab
TP chemotherapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab plus TP
Description:
The participants will receive camrelizumab (200 mg) through intravenous infusion each
2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2 through intravenous
infusion each 3-week cycle for 2 cycles.
Arm group label:
Neoadjuvant anti-PD-1 immunotherapy plus TP chemotherapy
Other name:
SHR-1210 plus Docetaxel, Cisplatin
Intervention type:
Drug
Intervention name:
TP
Description:
The participants will receive docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2 through
intravenous infusion each 3-week cycle for 2 cycles.
Arm group label:
Neoadjuvant TP chemotherapy
Other name:
Docetaxel, Cisplatin
Summary:
The purpose of this study is to investigate the survival benefit of neoadjuvant anti-PD-1
immunotherapy plus TP chemotherapy compared with TP chemotherapy or up-front surgery in
resectable locally advanced oral squamous cell carcinoma.
Detailed description:
On the basis of preliminary study, this study is to further verify the efficacy and
safety of neoadjuvant anti-PD-1 immunotherapy plus chemotherapy. The further purpose of
this study is to investigate the survival benefit of neoadjuvant anti-PD-1 immunotherapy
plus TP chemotherapy compared with TP chemotherapy or up-front surgery in resectable
locally advanced oral squamous cell carcinoma. And on this basis, the investigators will
explore the changes of the profiles and functions of immune cells within tumors, lymph
nodes and peripheral blood after the experimental interventions, as well as their
correlation with the patients' response and prognosis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically documented oral squamous cell carcinoma (biopsy required).
2. Local advanced oral squamous cell carcinoma (clinical stage T1-2N1-2M0, T3-4aN0-2M0)
with resection option for potential cure, as assessed by a faculty surgeon at
Hospital of Stomatology, Wuhan University.
3. Distant metastasis is excluded by chest CT and emission computed tomograph.
4. Adequate organ function as follows: 1) Leukocyte count ≥ 2,000/mm3; 2) Absolute
neutrophil count ≥ 1,000/mm3; 3) Platelet count ≥ 100,000/mm3; 4) Hemoglobin ≥ 90
g/L; 5) Serum albumin ≥30 g/L; 6) Total bilirubin ≤ 1.5 × upper limit of normal
(ULN); 7) AST (SGOT) and ALT (SGPT) < 2.5 × ULN; 8) ALP ≤ 2.5 × ULN; 9) Prothrombin
time-international normalized ratio ≤ 1.5; 10) Serum creatinine ≤ 1.5 × ULN; 11)
INR/PT≤ 1.5; 12) TSH ≤ ULN.
5. ECOG performance status 0-1.
6. Female patient tested HCG negative in serum or urine within 7 days prior to the
start of investigational product. Both patient and partner must agree to use
contraception prior to study entry and for the duration of study participation and
for up to 120 days after the last dose of PD-1 blockade.
7. Patient understands the study regimen, its requirements, risks and discomforts and
is able and willing to sign the informed consent form.
Exclusion Criteria:
1. History of ≥ 3 grade immune related adverse events (irAEs) or have not recovered to
≤ 1 grade irAEs from previous treatment.
2. History of other treatments for cancer, including surgery, chemotherapy,
radiotherapy or molecular targeted therapy within past 5 years.
3. Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other
antibody targeting T cell co-regulatory pathways.
4. Active autoimmune disease or history of refractory autoimmune disease.
5. Active systemic infection requiring therapy.
6. Patients who are receiving psychotropic drug or alcohol/drug abuse.
7. Subjects with concurrent other active malignancies.
8. HIV or untreated active HBV or HCV infections, or vaccinated (HBV, flu, varicella,
etc) within 4 weeks before recruitment.
9. Uncontrollable systemic diseases, including diabetes, hypertension, etc.
10. History of stroke or transient ischemic attack within past 6 months.
11. Distant metastases or inability to resect after physician evaluation.
12. Serious cardiovascular, respiratory, immune system critical disease or other
conditions that the researchers thought might increase the subjects' risk.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking university Shenzhen hospital
Address:
City:
Shenzhen
Zip:
518036
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hong-Yu Yang, M.D.
Phone:
0755-83923333
Email:
hyyang192@hotmail.com
Facility:
Name:
Hospital of Stomatology, Wuhan University
Address:
City:
Wuhan
Zip:
430079
Country:
China
Status:
Recruiting
Contact:
Last name:
Gang Chen, M.D.
Phone:
+86 02787686215
Email:
geraldchan@whu.edu.cn
Facility:
Name:
Xiangya Hospital of Central South University
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Recruiting
Contact:
Last name:
Tong Su, M.D.
Phone:
0731-89753046
Email:
sutong@csu.edu.cn
Start date:
November 21, 2023
Completion date:
October 1, 2026
Lead sponsor:
Agency:
Hospital of Stomatology, Wuhan University
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Hospital of Stomatology, Wuhan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05798793
