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

NCT07088484 | Not Yet Recruiting

• 1 other identifier: lrNPCimmuno
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recurrent Nasopharyngeal Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival

  Defined as the time from the initiation of ICI-chemotherapy to disease progression or death for any reason, whichever occurred first.

  Counting from the start of the treatment for two years.

Study Arms (1)

ICI-chemotherapy cohort

All included patients will undergo protocolized ICI-chemotherapy for 4-6 cycles, following by LIMT.

Drug: ICI-chemotherapy and LIMT

Interventions

ICI-chemotherapy and LIMT DRUG

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

ICI-chemotherapy cohort

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All included patients will undergo protocolized ICI-chemotherapy for 4-6 cycles, following by LIMT, with the local treatment be postponed or omitted.

You may qualify if:

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

You may not qualify if:

• Patients with distant metastasis of nasopharyngeal carcinoma.
• Patients who have not received immunotherapy or chemotherapy. (Alternatively: No prior immunotherapy or chemotherapy.)
• 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).
• Lack of capacity to provide informed consent.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

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

qiaojuan Guo

CONTACT

15080013157; guoqiaojuan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 28, 2025

Record last verified: 2025-07