Watch-and-Wait After Immunochemotherapy in Locally Recurrent Nasopharyngeal Carcinoma

Not yet recruiting

• Conditions: Recurrent Nasopharyngeal Carcinoma
• Interventions: Drug: ICI-chemotherapy and LIMT

• Registration Number: NCT07088484
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

The purpose of this study is to compare chemotherapy plus immunotherapy with immunochemotherapy combined subsequent locoregional radiotherapy in recurrent nasopharyngeal carcinoma (NPC), in order to confirm the value of immunotherapy and chemotherapy in recurrent NPC patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-20
• Study First Submitted QC: 2025-07-20
• Last Update Submitted: 2025-07-20
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-08-01
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age ≥ 18 years, regardless of sex.
2. Treatment-naïve patients with newly diagnosed metastatic nasopharyngeal carcinoma (NPC).
3. Receiving immunotherapy. (or Treated with immunotherapy)
4. At least one measurable tumor lesion according to RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1.
5. Adequate organ function.
6. Signed and dated informed consent form indicating that the patient (or legally authorized representative) has been informed of all pertinent aspects of the study.
7. Patients willing and able to comply with scheduled visits and study procedures.

Exclusion Criteria

1. Patients with distant metastasis of nasopharyngeal carcinoma.
2. Patients who have not received immunotherapy or chemotherapy. (Alternatively: No prior immunotherapy or chemotherapy.)
3. History of another active malignancy within the past 5 years, except for malignancies with a negligible risk of metastasis or death (e.g., expected 5-year overall survival >90%) or malignancies treated with curative intent and with no evidence of disease (e.g., adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, localized prostate cancer treated with curative intent, ductal carcinoma in situ of the breast treated surgically with curative intent).
4. Lack of capacity to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICI-chemotherapy cohort	ICI-chemotherapy and LIMT	All included patients will undergo protocolized ICI-chemotherapy for 4-6 cycles, following by LIMT.

Primary Outcome Measures

Name	Time	Method
2-year progression-free survival	Counting from the start of the treatment for two years.	Defined as the time from the initiation of ICI-chemotherapy to disease progression or death for any reason, whichever occurred first.