Actively Recruiting
QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.
Led by Sun Yat-Sen University Cancer Center · Updated on 2025-05-22
580
Participants Needed
19
Research Sites
291 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen University Cancer Center
Lead Sponsor
Q
Qilu Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial aimed to compare QL1706 combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in High-risk Locoregionally-Advanced Nasopharyngeal Carcinoma (LANPC).
CONDITIONS
Official Title
QL1706 (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma
- Tumor staged as T4N1 or T1-4N2-3 according to AJCC 9th edition
- Eastern Cooperative Oncology Group performance score of 0-1
- Adequate marrow function: white blood cell count > 4 x 10^9/L, hemoglobin > 90 g/L, platelet count > 100 x 10^9/L
- Adequate liver and kidney function with specific laboratory thresholds
- Normal thyroid function, serum amylase and lipase, pituitary hormone levels, inflammatory markers, cardiac enzyme tests, and electrocardiogram
- For patients over 50 years with smoking history, normal pulmonary function test results
- Additional cardiac assessments if ECG abnormalities or cardiovascular disease history
- Willing and able to comply with study schedule and provide informed consent
- Women of childbearing potential must agree to effective contraception during treatment and for 1 year after last dose
You will not qualify if you...
- Positive for hepatitis B surface antigen with high viral DNA levels, or positive for hepatitis C antibody
- Positive for HIV antibody or diagnosed with AIDS
- Active pulmonary tuberculosis within past year or treated improperly
- Active or suspected autoimmune diseases requiring systemic treatment (except some allowed conditions)
- Presence of thymic epithelial tumors
- History of interstitial lung disease or recent pneumonia requiring corticosteroids
- Ongoing systemic corticosteroid or immunosuppressive therapy (inhaled or topical allowed)
- Uncontrolled cardiac conditions including heart failure NYHA class II or above, unstable angina, recent myocardial infarction, or arrhythmias needing treatment
- Pregnant or breastfeeding women
- History or current other malignancies except some treated skin, cervical, or thyroid cancers
- Known allergy to QL1706 components
- Active infections requiring treatment within 1 week before enrollment
- Live vaccine administration within 30 days prior to first dose
- History of organ or stem cell transplantation
- Any other condition compromising safety or compliance as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Not Yet Recruiting
2
Dongguan People's Hospital
Dongguan, Guangdong, China
Not Yet Recruiting
3
First People's Hospital of Foshan
Foshan, Guangdong, China
Not Yet Recruiting
4
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
5
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
6
Zhongshan People's Hospital
Zhongshan, Guangdong, China
Not Yet Recruiting
7
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530000
Not Yet Recruiting
8
Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Not Yet Recruiting
9
Hubei Province Cancer Hosiptal
Wuhan, Hubei, China, 430000
Not Yet Recruiting
10
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Not Yet Recruiting
11
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
12
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
13
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
14
Xiangya Hospital of Central South University
Changsha, Hunan, China
Not Yet Recruiting
15
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
16
The Eye and ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
17
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610001
Not Yet Recruiting
18
Tianjin Medical University Cancer Institute ＆ Hospital
Tianjin, Tianjin Municipality, China, 30000
Not Yet Recruiting
19
The First Affiliated Hospital of Xiamen University
Fujian, Xiamen, China, 361000
Not Yet Recruiting
Research Team
J
Jun Ma, M.D.
CONTACT
R
Rui Guo, M.D.
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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