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

Fujian Provincial Cancer Hospital

Status: Not yet enrolling

Conditions: Recurrent Nasopharyngeal Carcinoma

Treatments: Drug: ICI-chemotherapy and LIMT

Study type: Observational

Funder types: Other

Identifiers

NCT07088484

lrNPCimmuno

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

50 participants in 1 patient group

ICI-chemotherapy cohort

Description:

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

Treatment:

Drug: ICI-chemotherapy and LIMT