Status:
RECRUITING
Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Zhongshan People's Hospital, Guangdong, China
Conditions:
Nasopharyngeal Cancer
Chemotherapy
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
Through multicenter, open-label, randomised clinical trials, high risk patients with nasopharyngeal carcinoma (staged as II-III with SD/PD according to RECIST criteria or EBV DNA of \>0 copies/mL afte...
Eligibility Criteria
Inclusion
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition).
- Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) with SD/PD according to RECIST criteria or EBV DNA of \>0 copies/mL after 3 cycles of GP induction chemotherapy.
- Aged between 18-70 years.
- Karnofsky scale (KPS)≥70.
- Normal bone marrow function.
- Normal liver and kidney function:
- total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
- creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
- Given written informed consent.
Exclusion
- Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
- Recurrent or metastatic nasopharyngeal carcinoma.
- Staged as II-III which is evaluated as PR or CR and EBV DNA of 0 copies/mL after 3 cycles of GP induction chemotherapy.
- Has known allergy to large molecule protein products or any compound of study therapy.
- Has known subjects with other malignant tumors.
- Has any active autoimmune disease or history of autoimmune disease.
- Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
- The laboratory examination value does not meet the relevant standards within 7 days before enrollment
- Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication.
- Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
- Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
- Has a known history of human immunodeficiency virus (HIV).
- Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
- Has received a live vaccine within 4 weeks of planned start of study therapy.
- Pregnancy or breast feeding.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
388 Patients enrolled
Trial Details
Trial ID
NCT04453826
Start Date
September 1 2020
End Date
September 1 2028
Last Update
September 28 2020
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
2
Cancer Center of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
3
Yuebei People's Hospital
Shaoguan, Guangdong, China, 512025
4
Zhongshan People's Hospital
Zhongshan, Guangdong, China, 528403