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

NCT07328854 | Recruiting Phase 3 DMC

• 1 other identifier: ZDWY.BYAFZZX.046
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; Reduced-dose radiotherapy; Complete response; Partial response; Epstein-Barr Virus DNA; Low-risk target volume

Outcome Measures

Primary Outcomes (2)

• Progress-Free Survival (PFS)

  Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

  3 years

• Incidence of ≥3 grade adverse events

  According to NCI-CTCAE 5.0, the proportion of patients who experienced ≥3 grade adverse events during treatment and follow-up.

  3 years

Secondary Outcomes (6)

• Distant Metastasis-Free Survival (DMFS)

  3 years

• Locoregional Relapse-Free Survival (LRRFS)

  3 years

• Overall Survival (OS)

  3 years

• Objective Response Rate (ORR)

  3 months

• Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)

  3 years

Study Arms (2)

Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy

EXPERIMENTAL

Drug: Cisplatin-based induction chemotherapy; Drug: Full course of PD-1 monoclonal antibody; Radiation: Reduced-dose radiotherapy to CTV2

Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy

ACTIVE COMPARATOR

Drug: Cisplatin-based induction chemotherapy; Drug: Full course of PD-1 monoclonal antibody; Radiation: Conventional-dose radiotherapy to CTV2

Interventions

Cisplatin-based induction chemotherapy DRUG

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.)

Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy; Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy

Full course of PD-1 monoclonal antibody DRUG

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.

Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy; Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy

Reduced-dose radiotherapy to CTV2 RADIATION

GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 40.2Gy/30F/1.34Gy

Reduced-dose radiotherapy to CTV2 combined with full-course immunotherapy

Conventional-dose radiotherapy to CTV2 RADIATION

GTV, 63.6Gy/30Fr/2.12Gy; CTV1, 54Gy/30Fr/1.8Gy; CTV2, 49.2Gy/30Fr/1.64Gy

Conventional-dose radiotherapy to CTV2 combined with full-course immunotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are informed of the basic content of this study and sign an informed consent form;
• Age between 18 and 75 years;
• Pathologically diagnosed as non-keratinising nasopharyngeal carcinoma (differentiated or undifferentiated, i.e., WHO type II or III);
• Staged according to the 9th edition of the AJCC/UICC TNM classification as T1-3N2M0 or T3N0-1M0 (Stage II);
• KPS ≥ 70;
• Normal bone marrow function: WBC ≥ 4 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L;
• Imaging evaluation of treatment response after three cycles of GPP/TPP induction chemotherapy plus immunotherapy: CR or PR;
• Plasma EBV DNA level decreases to 0 copies/mL or below the detection limit after induction chemotherapy;
• 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.

You may not qualify if:

• Patients with recurrent/metastatic nasopharyngeal carcinoma;
• Pregnant or breastfeeding women (pregnancy tests should be considered for women of childbearing age; effective contraception should be emphasised during treatment);
• 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;
• 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;
• 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;
• Patients with a history of severe hypersensitivity reactions to any component of PD-1 monoclonal antibodies;
• History of allergic reactions to the chemotherapy drugs used in this study (gemcitabine, docetaxel, albumin-bound paclitaxel, paclitaxel, cisplatin);
• Patients with comorbidities requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effects;
• Patients with active tuberculosis, or those currently receiving antituberculosis treatment or who have received antituberculosis treatment within the past year prior to screening;

Sponsors & Collaborators

• Ming-Yuan Chen: lead

Study Sites (15)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, China

RECRUITING

Sun Yat-sen University cancer center

Guangzhou, Guangdong, China

RECRUITING

the Affiliated Cancer Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

RECRUITING

Zhongshan City People's Hospital

Zhongshan, Guangdong, China

RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

RECRUITING

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

RECRUITING

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

RECRUITING

Central South University Cancer Hospital,

Changsha, Hunan, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ming-Yuan Chen, MD,PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Yuan Chen, MD,PhD

CONTACT

+86-20-87343361; chenmy@sysucc.org.cn

Rui You, MD,PhD

CONTACT

+86-13580439820; your5@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professior, Chief physician

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 9, 2026
• Study Start: November 20, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2032
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

CN (15)