Actively Recruiting
GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2024-06-25
216
Participants Needed
12
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to explore the efficacy and safety of neoadjuvant GP chemotherapy plus adebrelimab versus neoadjuvant GP chemotherapy in treating high-risk locoregionally advanced nasopharyngeal carcinoma patients.
CONDITIONS
Official Title
GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 65 years, men or non-pregnant women
- Histologically confirmed nonkeratinizing carcinoma of the nasopharynx (WHO II or III)
- Tumor staged as T4N0-1M0 or T1-4N2-3M0 (AJCC 8th edition)
- No previous anti-tumor treatment
- ECOG performance status of 0 or 1
- Adequate marrow function: WBC 64.0�D7109/L, Hemoglobin 6590g/L, Platelets 65100�D7109/L
- Liver enzymes (ALT, AST) and bilirubin no more than 2 times the upper limit of normal
- Adequate kidney function: creatinine clearance 6560 ml/min or creatinine 641.5 times upper limit of normal
You will not qualify if you...
- Recurrent or metastatic nasopharyngeal carcinoma
- Keratinizing squamous cell carcinoma of the nasopharynx
- Prior radiation therapy or systemic chemotherapy
- Pregnant, breastfeeding, or reproductive women without effective contraception
- HIV positive
- History of other cancers except cured basal cell carcinoma or carcinoma in situ of the cervix
- Prior treatment with immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, anti-CTLA-4)
- Immunodeficiency or organ transplant history
- Use of high-dose glucocorticoids, anticancer monoclonal antibodies, or immunosuppressants within 4 weeks
- Severe heart, liver, lung, kidney, or marrow dysfunction
- Severe uncontrolled diseases or infections
- Participation in other clinical trials or receipt of other investigational drugs
- Refusal or inability to provide informed consent
- Other treatment contraindications
- Personality or mental disorders limiting civil conduct
- Positive hepatitis B surface antigen with high HBV DNA levels
- Positive HCV antibody unless PCR test for HCV RNA is negative
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Foshan First People's Hospital
Foshan, Guangdong, China
Not Yet Recruiting
2
Affiliated cancer hospital and institute of guangzhou medical university
Guangzhou, China
Not Yet Recruiting
3
Sun Yat-Sen Memorial Hospital
Guangzhou, China
Not Yet Recruiting
4
The affiliated panyu central hospital of guangzhou medical university
Guangzhou, China
Not Yet Recruiting
5
ZhuJiang Hospital of Southern Medical University
Guangzhou, China
Not Yet Recruiting
6
Liuzhou Workers Hospital
Liuzhou, China
Not Yet Recruiting
7
Guangxi Medical University Affiliated Cancer Hospital
Nanning, China
Not Yet Recruiting
8
Cancer hospital of Shantou university medical college
Shantou, China
Not Yet Recruiting
9
Cancer hospital Chinese academy of medical sciences, Shenzhen center
Shenzhen, China
Not Yet Recruiting
10
The second people's hospital of Shenzhen
Shenzhen, China
Actively Recruiting
11
The university of Hongkong - Shenzhen hospital
Shenzhen, China
Not Yet Recruiting
12
Guangdong Medical School First Affiliated Hospital
Zhangjiang, China
Not Yet Recruiting
Research Team
H
Hai-Qiang Mai, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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