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

Watch-and-Wait Strategy in Patients With Objective Response After Immuno-chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma: A Prospective Multicenter Observational Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07088484

Enrollment

Registered

2025-07-28

Start date

2025-08-01

Completion date

2027-09-01

Last updated

2025-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

locally recurrent nasopharyngeal carcinoma, watch-and-wait strategy, immuno-chemotherapy, low-intensity maintenance treatment

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.

Interventions

DRUGICI-chemotherapy and LIMT

gemcitabine, docetaxel, paclitaxel, cisplatin, platinum, capecitabine, S1; Tislelizumab.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Contacts

Primary Contactqiaojuan Guo

guoqiaojuan@163.com15080013157

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026