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Clinical Trials in China / NCT06239727
Recruiting Phase 3

Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response

NCT06239727 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 3
Started
2024-03-01
Last updated
2026-03-06

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

PD-1 blocking antibody →Gemcitabine →Cisplatin (80 mg/m2) →Reduced-dose Intensity-modulated radiotherapyConventional-dose Intensity-modulated radiotherapyCisplatin (100 mg/m2) →Capecitabine →

PD-1 blocking antibody: 1. IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 200 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC. 2. Adjuvant PD-1 blocking antibody: every 3 weeks × 9 cycles; 200 mg, day 1.

Gemcitabine: Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles.

Cisplatin (80 mg/m2): Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.

Reduced-dose Intensity-modulated radiotherapy: 1. Definitive IMRT, 30 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6360cGy/30F; pCTV1: 5460cGy/30F; pCTV2: 4920cGy/30F.

Conventional-dose Intensity-modulated radiotherapy: 1. Definitive IMRT, 33 fractions, 5 fractions/week, 1 fraction/day 2. Radiotherapy dose: pGTV: 6996cGy/33F; pCTV1: 6006cGy/33F; pCTV2: 5412cGy/33F.

Cisplatin (100 mg/m2): Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles

Capecitabine: Metronomic adjuvant capecitabine chemotherapy: 650 mg/m2 p.o. bid, 1 year, adminstration starts immediately after concurrent chemoradiotherapy.

Study summary

This is an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial aimed to investigate the impact of reduced-dose radiotherapy in combination with chemotherapy and immunotherapy on patients' prognosis and complication compared with conventional-dose radiotherapy in combination with chemotherapy and immunotherapy for treatment-sensitive stage III NPC patients screened out according to the treatment response.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age: 18 Years to 65 Years; 2. Eastern Cooperative Oncology Group performance status ≤1; 3. Patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma, the pathological type is non-keratinising carcinoma; 4. Tumor staged as Stage III (T3N0 Excepted; AJCC 8th); 5. Patients' lymph node without adverse features (no central necrosis, no muscle/skin invasion, no lymph node fusion); 6. Normal bone marrow function: white blood cell count \> 4×10\^9/L, hemoglobin \> 90g/L, platelet count \> 100×10\^9/L; 7. Normal liver and kidney function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine transaminase and aspartate transaminase ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN, creatinine clearance rate ≥ 60 ml/min; 8. Receive 3 cycles of indction chemotherapy (GP regimen + Camrelizumab); 9. Plasma EBV DNA after the second cycle of concurrent chemotherapy: negative; 10. Complete remission after 27 fractions of radiotherapy based on the MRI examination of the nasopharynx and neck (According to Response Evaluation Criteria in Solid Tumors 1.1); 11. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule; 12. Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment. Exclusion Criteria: 1. Hepatitis B virus surface antigen (HBsAg) positive and Hepatitis B virus DNA \> 1000 copies/ml; 2. Anti-hepatitis C virus positive; 3. Anti-human immunodeficiency virus (HIV) positive or diagnosed with acquired immune deficiency syndrome (AIDS); 4. Active tuberculosis: active tuberculosis in the past 1 year should be excluded regardless with treatment, history of active tuberculosis over 1 year should be excluded except that previous regulatory anti-tuberculosis treatment is proved; 5. Active, known or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchiectasis). Exceptions are type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia); 6. Previous interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy; 7. Chronic treatment with systemic glucocorticoid (dose equivalent to or over 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who used inhaled or topical corticosteroids were eligible; 8. Uncontrolled heart disease, for example: 1) heart failure (NYHA level ≥ 2), 2) unstable angina, 3) myocardial infarction in past 1 year, 4) supraventricular or ventricular arrhythmia requiring treatment or intervention; 9. Active infection requiring systemic treatment; 10. Previous or concurrent with other malignant tumors, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary cancer; 11. History of radiotherapy, except for non-melanoma skin cancer located outside the target volume of radiotherapy for nasophayngeal carcinoma; 12. Receive treatment for the local or regional disease other than that specified in the research plan; 13. Pregnant or lactating women (pregnancy test should be considered for women with sexual life and fertility); 14. Allergy to macromolecular protein preparations, or any component of Camrelizumab; 15. Receiving live vaccine within 30 days of the initial Camrelizumab; 16. Contraindications to MRI examination, for example: claustrophobia, allergy to MRI contrast; 17. History of psychotropic disease, alcoholism or drug abuse, and other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Fujian Cancer Hospital Fuzhou Fujian Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
Dongguan People's Hospital Dongguan Guangdong Recruiting
The First People's Hospital of Foshan Foshan Guangdong Recruiting
Sun Yat-Sen University Cancer Center Guangzhou Guangdong Recruiting
The Affiliated Panyu Central Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting
Cancer Hospital of Shantou University Medical College Shantou Guangdong Recruiting
Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong Recruiting
Guangdong Nongken Central Hospital Zhanjiang Guangdong Recruiting
Cancer Hospital of Guangxi Medical University Nanning Guangxi Recruiting
Cancer Hospital of Guizhou Medical University Guiyang Guizhou Recruiting
The Second Affiliated Hospital of Hainan Medical University Haikou Hainan Recruiting
Hubei Province Cancer Hosiptal Wuhan Hubei Recruiting
Tongji Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei Recruiting
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Xiangya Hospital Central South University Changsha Hunan Recruiting
Jiangsu Cancer Hospital Nanjing Jiangsu Recruiting
Jiangsu Provinee Hospital of Chinese Medicine Nanjing Jiangsu Recruiting
Jiangxi Cancer Center Nanchang Jiangxi Recruiting
The First Affiliated Hospital of Xian Jiaotong University Xian Shanxi Recruiting
Sichuan Cancer Hospital Chengdu Sichuan Recruiting
West China Hospital,Sichuan University Chengdu Sichuan Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting
Chongqing Cancer Hospital Chongqing China Recruiting
Tianjin Medical University Cancer Institute & Hospital Tianjin China Recruiting

More Sun Yat-sen University trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06239727 on ClinicalTrials.gov ↗ ← All trials in China