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40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma Under Full-Course Immunotherapy: a Multicentre, Randomised, Phase 3 Trial
Led by Ming-Yuan Chen · Updated on 2026-01-09
346
Participants Needed
15
Research Sites
104 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying patients with low-risk intermediate-stage nasopharyngeal carcinoma who have responded well to induction chemotherapy and have undetectable levels of plasma EBV-DNA. The trial compares two doses of radiotherapy targeting a specific low-risk area to evaluate their effects on survival, side effects, and quality of life. This phase 3 randomized study aims to find out if lower-dose radiotherapy can maintain treatment success while reducing toxicities related to treatment. Participants receive either reduced-dose radiotherapy (40.2Gy) or conventional-dose radiotherapy (49.2Gy) to the low-risk target volume called CTV2. Both groups undergo full-course immunotherapy with the PD-1 monoclonal antibody Tislelizumab, administered every three weeks, totaling 12 courses through induction, radiotherapy, and maintenance phases. Induction chemotherapy using a cisplatin-based regimen is given before radiotherapy. Treatment continues until toxicity, progression, withdrawal, or completion of planned courses. During the study, patients will be monitored for progression-free survival and serious adverse events over three years. Secondary measures include metastasis-free survival, relapse-free survival, overall survival, tumor response rates, and quality of life assessments using standard questionnaires over three years. Safety and effectiveness will be evaluated through imaging, laboratory tests, and clinical evaluations. The study enrollment includes adults aged 18 to 75 years, and the follow-up will provide information on long-term outcomes and treatment impact.
CONDITIONS
Brief Title
40.2Gy Versus 49.2Gy Radiotherapy in Low-Risk Target Volume for Chemosensitive Stage II Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who provide informed consent to participate in the study
- Age between 18 and 75 years
- Diagnosed with non-keratinising nasopharyngeal carcinoma (WHO type II or III)
- Stage II disease defined as T1-3N2M0 or T3N0-1M0 according to the 9th edition AJCC/UICC TNM classification
- Karnofsky Performance Status (KPS) score of 70 or higher
- Normal bone marrow function (WBC ≥ 4 x 10⁹/L, PLT ≥ 100 x 10⁹/L, HGB ≥ 90 g/L)
- Achieved complete or partial response after three cycles of induction chemotherapy plus immunotherapy
- Plasma EBV DNA level decreased to 0 copies/mL or below detection limit after induction chemotherapy
- Normal liver and kidney function (bilirubin, AST, ALT ≤ 2 times upper limit; creatinine clearance ≥ 60 mL/min or creatinine ≤ 1.5 times upper limit)
You will not qualify if you...
- Recurrent or metastatic nasopharyngeal carcinoma
- Pregnant or breastfeeding women
- History of malignant tumors except for certain cured cancers (cervical, basal cell or squamous cell skin carcinoma, localized prostate cancer, or ductal carcinoma in situ)
- Prior radiotherapy or surgery to local/regional lesions (except diagnostic surgery) or lesions unsuitable for radiotherapy
- Severe medical conditions that increase risk or impair study compliance (unstable cardiac, renal, hepatic disease, uncontrolled diabetes, severe psychiatric disorders)
- History of severe allergic reactions to PD-1 monoclonal antibodies
- Allergic reactions to chemotherapy drugs used in the study (gemcitabine, docetaxel, albumin-bound paclitaxel, paclitaxel, cisplatin)
- Long-term use of immunosuppressive drugs or corticosteroids with immunosuppressive effects
- Active tuberculosis or recent antituberculosis treatment within one year
- Any other condition considered unsuitable by the treating physician
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive three cycles of cisplatin-based induction chemotherapy combined with PD-1 monoclonal antibody immunotherapy.
3 visits every 3 weeks for chemotherapy and immunotherapy administration
Duration - Approximately 6 weeks
Participants receive either reduced-dose or conventional-dose radiotherapy to specific target volumes combined with three courses of PD-1 monoclonal antibody immunotherapy.
Daily radiotherapy visits for about 6 weeks and 3 immunotherapy visits every 3 weeks
Duration - Approximately 18 weeks
Participants continue PD-1 monoclonal antibody immunotherapy for maintenance following radiotherapy.
6 immunotherapy visits every 3 weeks
Duration - Up to 3 years
Participants are followed up to observe differences in survival, adverse events, and quality of life for up to 3 years after treatment.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 15 locations
1
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
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2
Fujian Cancer Hospital
Fuzhou, Fujian, China
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3
Sun Yat-sen University cancer center
Guangzhou, Guangdong, China
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4
the Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
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5
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
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6
Zhongshan City People's Hospital
Zhongshan, Guangdong, China
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7
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China
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8
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
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9
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
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10
Central South University Cancer Hospital,
Changsha, Hunan, China
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11
Xiangya Hospital of Central South University
Changsha, Hunan, China
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12
West China Hospital, Sichuan University
Chengdu, Sichuan, China
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13
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
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14
Yunnan Cancer Hospital
Kunming, Yunnan, China
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15
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
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Research Team
M
Ming-Yuan Chen, MD,PhD
R
Rui You, MD,PhD
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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