Recurrent Nasopharyngeal CarcinomaNCT07088484
Watch-and-Wait After Immunochemotherapy in Locally Recurrent Nasopharyngeal Carcinoma
An observational study of Recurrent Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- ICI-chemotherapy and LIMT
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Watch-and-Wait Strategy in Patients With Objective Response After Immuno-chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma: A Prospective Multicenter Observational Study
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
- Being tested
- ICI-chemotherapy and LIMT
- Keywords
- locally recurrent nasopharyngeal carcinoma, watch-and-wait strategy, immuno-chemotherapy, low-intensity maintenance treatment
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICI-chemotherapy and LIMTDrug
gemcitabine, docetaxel, paclitaxel, cisplatin, platinum, capecitabine, S1; Tislelizumab.
| Study group | Role | What they receive |
|---|---|---|
| ICI-chemotherapy cohort | All included patients will undergo protocolized ICI-chemotherapy for 4-6 cycles, following by LIMT. Receives: Drug: ICI-chemotherapy and LIMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Counting from the start of the treatment for two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088484
- Sponsor's protocol ID
- lrNPCimmuno
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Watch-and-Wait Strategy in Patients With Objective Response After Immuno-chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma: A Prospective Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT07088484
- Acronym / sponsor ID
- lrNPCimmuno
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Keywords
- locally recurrent nasopharyngeal carcinoma, watch-and-wait strategy, immuno-chemotherapy, low-intensity maintenance treatment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICI-chemotherapy cohort | – | Drug: ICI-chemotherapy and LIMTAll included patients will undergo protocolized ICI-chemotherapy for 4-6 cycles, following by LIMT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICI-chemotherapy and LIMTgemcitabine, docetaxel, paclitaxel, cisplatin, platinum, capecitabine, S1; Tislelizumab. | Drug | ICI-chemotherapy cohort |
Primary outcome
2-year progression-free survival
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Nasopharyngeal Carcinoma, run by Fujian Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qiaojuan Guo (15080013157, guoqiaojuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year progression-free survival (time frame: Counting from the start of the treatment for two years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.