Clinical trial · Interventional
Stop and go Strategy as First-line Treatment for Widely Metastatic Nasopharyngeal Carcinoma
Stop and go Strategy as First-line Treatment in Patients With Objective Response After Systematic Chemotherapy for Widely de Novo Metastatic Nasopharyngeal Carcinoma: A Phase II Trial
NCT06331845CI-TRIAL-00075435not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aimed to investigate the value of a novel strategy of intermittent systematic chemotherapy (ISC) in widely metastatic nasopharyngeal carcinoma (wmNPC) patients who achieve objective response after systematic chemotherapy (SC).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intermittent Systematic Chemotherapy | — | UNRESOLVED | — |
| Metastatic Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Paclitaxel protein-bound | Drug | Nab-paclitaxel | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intermittent systematic chemotherapy group
- description
- Patients diagnosed with wmNPC (more than five metastatic lesions) by histopathology are assigned to receive ISC following SC. Typically, SC(GP) was administered once every three weeks, with a maximum of six courses. Following this, ISC (TS1) was administered to extend the chemotherapy interval, once every 6-8 weeks, until widely progressive disease (WPD: defined as more than five progressive lesions), treatment intolerance, or patient refusal.
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
- Drug: Paclitaxel protein-bound
- Drug: Capecitabine
- Drug: Tislelizumab
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 1 year
- description
- the time interval from the start of chemotherapy to the date of progression
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with multiple metastases at first diagnosis or multiple metastases after treatment(multiple metastases were defined as more than 5 lesions and/or more than 2 metastasis organs); Histologically or cytologically confirmed multiple metastatic NPC. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at trial entry, and life expectancy ≥ 6 months as judged by the Investigator; 3. The disease must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Adequate organ function; 4. Take adequate contraceptive measures throughout the study, and contraception continues until 12 months after treatment; 5. Able and willing to provide a signed informed consent form, and able to comply with all procedures. 6. The time from the last chemotherapy and/or radiotherapy to randomization must be ≥6 months. Exclusion Criteria: 1. Patients with a hypersensitivity to any of the drugs used in our study; 2. With any active autoimmune disease or history of autoimmune disease; 3. Clinically significant cardiovascular and cerebrovascular diseases; 4. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer); 5. Active systemic infection; 6. Drug or alcohol abuse; 7. No or limited capacity for civil conduct; 8. The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study; 9. History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy； 10. Use cortisol or other systematic immunosuppressive medications within 4 weeks before the study treatment, and the subject requiring hormone therapy during trials. 11. Pregnancy or breastfeeding.
References
Publications (0)
Data not yet available
No reference posted for this study.