Phase III Non-Inferiority Trial: Reduced-Target vs. Full-Target IMRT After Chemo in Immunotherapy-Treated Metastatic Nasopharyngeal Cancer

NCT07188584 | Recruiting Phase 3

• 1 other identifier: ZDWY[2025] Lunzi No. (K66)
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

In order to further verify the effectiveness of the new prevention irradiation model for low-risk areas for nasopharyngeal carcinoma under immunotherapy, our team intends to conduct a non-inferiority clinical trial. The aim is to evaluate the efficacy and safety of two treatment modalities - local region reduced-target radiotherapy versus full-target radiatiotherapy (with/without CTV2) for newly diagnosed distant metastasis nasopharyngeal carcinoma, based on the full-course immunotherapy and full-dose chemotherapy. The primary endpoints are 2-year PFS and the incidence of grade 3 or higher radiation-related adverse events. If non-inferiority is confirmed, a new standard of "immunotherapy combined with reduced-target radiotherapy" will be established, ensuring efficacy while significantly reducing toxicity, and providing a more optimal comprehensive treatment strategy for nasopharyngeal carcinoma.

Conditions

Nasopharyngeal Carcinoma (NPC)

Keywords

Distant Metastasis Nasopharyngeal Carcinoma; Full Course Immunotherapy; Reduced-Target Radiotherapy; Full-dose Chemotherapy

Outcome Measures

Primary Outcomes (2)

• 2-year Progression-Free Survival (PFS)

  The PFS was defined as the duration from the date of random assignment to the date of disease progression or censored at the date of the last follow-up.

  2 years

• The incidence rate of radiotherapy-related ≥ grade 3 adverse events

  Including the evaluation of acute subjective and objective toxic reactions as well as the evaluation of late subjective toxic reactions. The NCI-CTC 5.0 standard and RTOG standard were adopted.

  2 years

Secondary Outcomes (6)

• Objective Response Rate(ORR)

  2 years

• Disease control rate (DCR)

  2 years

• Overall survival time (OS)

  2 years

• Health-related Quality of Life

  2 years

• Adverse Events Reporting

  2 years

Study Arms (2)

Reduced-Target Radiotherapy after Full-dose Chemotherapy under Full-course Immunotherapy

EXPERIMENTAL

Immunotherapy: Patients received maintenance treatment with PD-1 monoclonal antibody (a 3-week course as one cycle) until disease progression or reach 2 years. Chemotherapy: Platinum-containing doublet chemotherapy (before enrollment, 4-6 cycles) and concurrent cisplatin during radiotherapy. Radiotherapy: Patients received intensity-modulated radiotherapy technology. Experimental group: GTVnx: 69.96 Gy/33 Fr/2.12 Gy; GTVnd: 69.96 Gy/33 Fr/2.12 Gy; CTV1: 60.60 Gy/33 Fr/1.82 Gy; GTV2: No prescription dose (only delineated, actual dose is scattered dose).

Radiation: Reduced-Target Radiotherapy

Conventional Full-Target Radiotherapy after Full-dose Chemotherapy under Full-course Immunotherapy

ACTIVE COMPARATOR

Immunotherapy: Patients received maintenance treatment with PD-1 monoclonal antibody (a 3-week course as one cycle) until disease progression or reach 2 years. Chemotherapy: Platinum-containing doublet chemotherapy (before enrollment, 4-6 cycles) and concurrent cisplatin during radiotherapy. Radiotherapy: Patients received intensity-modulated radiotherapy technology. Control group: GTVnx: 69.96 Gy/33 F/2.12 Gy; GTVnd: 69.96 Gy/33 F/2.12 Gy; CTV1: 59.4 Gy/33 F/1.8 Gy; CTV2: 54 Gy/33 F/1.64 Gy.

Radiation: Conventional Full-Target Radiotherapy

Interventions

Reduced-Target Radiotherapy RADIATION

Experimental group: GTVnx: 69.96 Gy/33 Fr/2.12 Gy; GTVnd: 69.96 Gy/33 Fr/2.12 Gy; CTV1: 60.60 Gy/33 Fr/1.82 Gy; GTV2: No prescription dose (only delineated, actual dose is scattered dose).

Reduced-Target Radiotherapy after Full-dose Chemotherapy under Full-course Immunotherapy

Conventional Full-Target Radiotherapy RADIATION

Control group: GTVnx: 69.96 Gy/33 F/2.12 Gy; GTVnd: 69.96 Gy/33 F/2.12 Gy; CTV1: 59.4 Gy/33 F/1.8 Gy; CTV2: 54 Gy/33 F/1.64 Gy.

Conventional Full-Target Radiotherapy after Full-dose Chemotherapy under Full-course Immunotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years - 70 years.
• The patient has signed the informed consent form and is willing and able to follow the visit schedule, treatment plan, laboratory tests and other research procedures as per the research plan.
• Newly diagnosed distant metastasis patients who achieved complete response (CR) or partial response (PR) after receiving adequate first-line systematic therapy (platinum-containing doublet chemotherapy + PD-1 monoclonal antibody).
• Nasopharyngeal carcinoma non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III), confirmed by histological and/or cytological examination, with metastatic lesions detected on imaging (biopsy of metastatic tissue is preferred but not mandatory).
• Clinical stage: TanyNanyM1, stage IVB (AJCC 9th edition).
• ECOG score: 0-1.
• Female subjects with reproductive capacity must have a negative urine or serum pregnancy test within 7 days prior to enrollment, and must agree to take effective contraceptive measures during the study.
• For male subjects, if the female partner still has reproductive capacity, the male subject must agree to take effective contraceptive measures during the study.

You may not qualify if:

• Patients with malignant pleural effusion or those with other malignant tumors
• Patients who have received ≥2 prior lines of systemic therapy.
• Patients with known or suspected autoimmune diseases, including dementia and epileptic seizures.
• Patients with grade ≥ II coronary heart disease, arrhythmia (including QTc interval prolongation in males \> 450 ms, females \> 470 ms) and heart failure.
• Patients who received systemic or local glucocorticoid treatment within 4 weeks prior to enrollment.
• Patients with comorbidities requiring long-term use of immunosuppressive drugs or requiring systemic or local use of corticosteroids at immunosuppressive doses.
• Patients with active pulmonary tuberculosis (TB), who are undergoing anti-TB treatment or have received anti-TB treatment within 1 year prior to screening.
• HIV-positive individuals; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C blood screening positive (HCV antibody positive).
• Patients who received any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment.
• At the time of randomization, the expected lifespan of the patients was less than 6 months.

Sponsors & Collaborators

• Ming-Yuan Chen: lead
• Cancer Hospital of Guangxi Medical University: collaborator
• Fujian Cancer Hospital: collaborator
• The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• Zhejiang Cancer Hospital: collaborator
• West China Hospital: collaborator
• Xiangya Hospital of Central South University: collaborator
• Affiliated Cancer Hospital of Shantou University Medical College: collaborator
• Yunnan Cancer Hospital: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• Wuzhou Red Cross Hospital: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Southern Medical University, China: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• Sun Yat-Sen University Cancer Center: collaborator

Study Sites (1)

The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong 519000 Recruiting

Zhuhai, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

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

Central Study Contacts

Ming-Yuan Chen, MD,PhD

CONTACT

86-13903052650; chmingy@mail.sysu.edu.cn

Rui You, MD, PhD

CONTACT

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

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: September 23, 2025
• Study Start: August 20, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): July 1, 2031
• Last Updated: December 9, 2025

Record last verified: 2025-12

Locations

CN (1)