PD-1 Antibody Combined With Chemoradiotherapy in Recurrent Nasopharyngeal Carcinoma Patients
1 other identifier
interventional
212
1 country
12
Brief Summary
This is a multicenter, randomized controlled, phase III clinical trial. The purpose of this study is to evaluate the efficacy and adverse effect of PD-1 antibody with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2020
Longer than P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedStudy Start
First participant enrolled
March 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
May 7, 2026
May 1, 2026
6.8 years
April 5, 2019
May 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
From date of randomisation to death
3 years
Secondary Outcomes (4)
Progression free survival
3 years
Short-term effects
through study completion, an average of 2 months
Rate of patients with acute toxicities
through study completion, an average of 2 months
Quality of life: EuroQoL 5 dimension
through whole study, an average of 3 years
Study Arms (2)
PD-1 antibody plus chemoradiotherapy
EXPERIMENTALPatients randomized to this arm will receive three cycles of PD-1 antibody (JS001, 240mg every three weeks) combined with GP chemotherapy, then receive IMRT and PD-1 antibody maintenance for eight cycles.
Chemoradiotherapy
ACTIVE COMPARATORPatients randomized to this arm will receive three cycles of GP chemotherapy, then receive IMRT alone.
Interventions
Toripalimab 240mg, D1, every 3 weeks per cycle
Gemcitabine 1.0g/m2, D1 and D8; Cisplatin 80mg/m2, D1, every 3 weeks per cycle, total three cycles
Eligibility Criteria
You may qualify if:
- Diagnosed as local recurrence ± regional recurrence after ≥1 year of radical treatment;
- Not suitable for surgery;
- Newly histologic diagnosis of NPC (WHO II/III);
- Clinical stage rII-IVa (AJCC/UICC 8th);
- ECOG 0-1 point;
- No treatment to rNPC, such as radiotherapy, chemotherapy, immunotherapy or biotherapy;
- No contraindications to immunotherapy or radiotherapy;
- Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L;
- Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN;
- Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- Take effective contraceptions during and two months after treatment;
- Patients must be informed of the investigational nature of this study and give written informed consent.
You may not qualify if:
- Treated with anti-tumor Chinese medicine treatment;
- Have recurrence with local necrosis;
- Have ≥G3 late toxicities, except for skin, subcutaneous tissue or mucosa;
- Unexplained fever \> 38.5 ℃, except for tumor fever;
- Treated with ≥ 5 days antibiotics one month before enrollment;
- Have active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy); Have a known history of human immunodeficiency virus (HIV), active Hepatitis B (HBV-DNA ≥10E4copiers/ml) or hepatitis C virus (HCV) antibody positive; Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway;
- Have New York Heart Association (NYHA) class 3 or 4, unstable angina, myocardial -infarction within 1 year, or clinically meaningful arrhythmia that requires treatment;
- Have known allergy to large molecule protein products or any compound of study therapy;
- Pregnant or breastfeeding;
- Prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical cancer, and papillary thyroid carcinoma;
- Have received a live vaccine within 30 days of planned start of study therapy Has psychiatric drug or substance abuse disorders that would interfere with cooperation with the requirements of the trial;
- Any other condition, including mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Peking University Third Hospital
Beijing, China
Sichuan Cancer Hospital
Chengdu, China
Fujian Province Cancer Hospital
Fuzhou, China
Guizhou Cancer Hospital
Guiyang, China
Zhejiang Cancer Hospital
Hangzhou, China
Jiangxi Cancer Hospital
Nanchang, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Fudan University Shanghai Cancer Center
Shanghai, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Xijing Hospital
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chong Zhao
Sun Yat-Sen University Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
April 5, 2019
First Posted
April 9, 2019
Study Start
March 1, 2020
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2028
Last Updated
May 7, 2026
Record last verified: 2026-05