Actively Recruiting
Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
Led by Sun Yat-sen University · Updated on 2020-09-28
388
Participants Needed
6
Research Sites
417 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
A
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.
CONDITIONS
Official Title
Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III)
- Cancer staged as T4N0-2M0, T1-4N3M0 (stage IVa) or T1-3N1-2M0, T2-3N0M0 (stage II-III) with stable or progressive disease after 3 cycles of induction chemotherapy
- Age between 18 and 70 years
- Karnofsky performance score of at least 70
- Normal bone marrow function
- Normal liver and kidney function with total bilirubin, AST, and ALT levels no more than 2.5 times the upper normal limit
- Creatinine clearance rate at least 60 mL/min or creatinine no more than 1.5 times the upper normal limit
- Provided written informed consent
You will not qualify if you...
- Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma
- Recurrent or metastatic nasopharyngeal carcinoma
- Stage II-III with partial or complete response and EBV DNA of 0 copies/mL after 3 cycles of induction chemotherapy
- Known allergy to large molecule protein products or any study therapy compound
- Presence of other malignant tumors
- Active or history of autoimmune disease
- History of psychiatric substance abuse, alcoholism, or drug addiction
- Laboratory values outside required standards within 7 days before enrollment
- Systematic glucocorticoid therapy within 4 weeks before first study medication dose
- Active tuberculosis within the past year
- Prior treatment with PD-1, PD-L1, or CTLA-4 agents
- Active autoimmune diseases requiring systemic treatment (except some skin diseases)
- Known HIV infection
- Positive hepatitis B surface antigen with high viral load or hepatitis C antibody positive
- Received live vaccine within 4 weeks before study therapy
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
2
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
Not Yet Recruiting
3
Yuebei People's Hospital
Shaoguan, Guangdong, China, 512025
Not Yet Recruiting
4
Zhongshan People's Hospital
Zhongshan, Guangdong, China, 528403
Actively Recruiting
5
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Actively Recruiting
6
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China, 543002
Not Yet Recruiting
Research Team
M
Ming-Yuan Chen, MD, PhD
CONTACT
R
Rui You, 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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