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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFujian Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ICI-chemotherapy and LIMT

    Drug

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: ICI-chemotherapy cohort1 intervention

Trial outcomes

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.

Time frame
Counting from the start of the treatment for two years.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: