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Clinical Trials in China / NCT07328854
Recruiting Phase 3

40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma

NCT07328854 · tracked via the Priya Life Science China tracker
Sponsor
Ming-Yuan Chen
Phase
Phase 3
Started
2025-11-20
Last updated
2026-01-09

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

Cisplatin-based induction chemotherapyFull course of PD-1 monoclonal antibodyReduced-dose radiotherapy to CTV2Conventional-dose radiotherapy to CTV2

Cisplatin-based induction chemotherapy: Gemcitabine + cisplatin: Gemcitabine, 1,000 mg/m², Q3W, d1+d8, IV drip; cisplatin, 80 mg/m², Q3W, d1-3, IV drip. A total of 3 cycles. (Note: Gemcitabine can be replaced by docetaxel, albumin-bound paclitaxel, paclitaxel, etc.)

Full course of PD-1 monoclonal antibody: Tislelizumab 200 mg , once every 3 weeks (Q3W), intravenous infusion (iv). A total of 12 courses of treatment will be administered, including 3 courses during the induction chemotherapy phase, 3 courses during the radiotherapy phase, and 6 courses during the post-radiotherapy maintenance phase. Administration will start on Day 1 of induction chemotherapy and continue after the end of radiotherapy until the occurrence of intolerable toxicities, disease progression, withdrawal of consent, determination by the investigator that the patient needs to withdraw from treatment, or the completion of 12 courses, whichever comes first.

Reduced-dose radiotherapy to CTV2: GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 40.2Gy/30F/1.34Gy

Conventional-dose radiotherapy to CTV2: GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 49.2Gy/30Fr/1.64Gy

Study summary

This study aims to explore the efficacy and adverse events of reduced-dose radiotherapy (40.2Gy) versus conventional-dose radiotherapy (49.2Gy) to low-risk target volume for chemosensitive intermediate-stage nasopharyngeal carcinoma patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients are informed of the basic content of this study and sign an informed consent form; 2. Age between 18 and 75 years; 3. Pathologically diagnosed as non-keratinising nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III); 4. Staged according to the 9th edition of the AJCC/UICC TNM classification as T1-3N2M0 or T3N0-1M0 (Stage II); 5. KPS ≥ 70; 6. Normal bone marrow function: WBC ≥ 4 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L; 7. Imaging evaluation of treatment response after three cycles of GPP/TPP induction chemotherapy plus immunotherapy: CR or PR; 8. Plasma EBV DNA level decreases to 0 copies/mL or below the detection limit after induction chemotherapy; 9. Normal liver and kidney function: total bilirubin, AST, ALT ≤ 2.0 times the upper limit of normal, creatinine clearance ≥ 60 mL/min or creatinine ≤ 1.5 times the upper limit of normal. Exclusion Criteria: 1. Patients with recurrent/metastatic nasopharyngeal carcinoma; 2. Pregnant or breastfeeding women (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasised during treatment); 3. Patients with a history of malignant tumours, excluding those who have undergone curative treatment for cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, or ductal carcinoma in situ; 4. Patients whose local/regional lesions have undergone radiotherapy or surgery (excluding diagnostic surgery), or whose lesions exhibit significant necrosis, making radiotherapy unsuitable or potentially leading to radiotherapy resistance; 5. Patients with other severe medical conditions that may pose significant risks or impair trial compliance. Examples include unstable cardiac disease requiring treatment, renal disease, hepatic disease, uncontrolled diabetes (fasting blood glucose \> 1.5 × ULN), severe psychiatric disorders, or other malignant tumours; 6. Patients with a history of severe hypersensitivity reactions to any component of PD-1 monoclonal antibodies; 7. History of allergic reactions to the chemotherapy drugs used in this study (gemcitabine, docetaxel, albumin-bound paclitaxel, paclitaxel, cisplatin); 8. Patients with comorbidities requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects; 9. Patients with active tuberculosis, or those currently receiving antituberculosis treatment or who have received antituberculosis treatment within the past year prior to screening; 10. Other patients deemed ineligible for inclusion by the treating physician.

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Anhui Provincial Cancer Hospital Hefei Anhui Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Sun Yat-sen University cancer center Guangzhou Guangdong Recruiting
the Affiliated Cancer Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting
Cancer Hospital of Shantou University Medical College Shantou Guangdong Recruiting
Zhongshan City People's Hospital Zhongshan Guangdong Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University Zhuhai Guangdong Recruiting
Guangxi Medical University Cancer Hospital Nanning Guangxi Recruiting
Wuzhou Red Cross Hospital Wuzhou Guangxi Recruiting
Central South University Cancer Hospital, Changsha Hunan Recruiting
Xiangya Hospital of Central South University Changsha Hunan Recruiting
West China Hospital, Sichuan University Chengdu Sichuan Recruiting
The First Affiliated Hospital of Kunming Medical University Kunming Yunnan Recruiting
Yunnan Cancer Hospital Kunming Yunnan Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting

More Ming-Yuan Chen trials in China

Other trials for the same condition

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 NCT07328854 on ClinicalTrials.gov ↗ ← All trials in China