Clinical trial · Interventional
A Clinical Trial of Chemotherapy With Lobaplatin and 5-FU in Recurrent Local or Distant Advanced NPC.
A Prospective, Single-arm, and Open Clinical Trial of Chemotherapy With Lobaplatin and 5-FU on Efficacy and Safety in Recurrent Local or Distant Advanced NPC.
NCT03210389CI-TRIAL-00028509unknownPhase 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)
The purpose of this study is to evaluate the efficacy and safety of chemotherapy with Lobaplatin and 5-FU, in Recurrent Local or Distant Advanced Nasopharyngeal Carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lobaplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lobaplatin+5-FU
- description
- Patients enrolled in this trial would get 4-6 cycles of lobaplatin + 5-FU chemotherapy.
- interventionNames
- Drug: Lobaplatin
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 2 years after chemotherapy
- description
- the time from randomization to death or disease progression
Secondary outcomes (2)
- measure
- overall survival
- timeFrame
- 2 years after chemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * NPC diagnosed by pathology, with measurable lesions and imaging results, such as MRI and CT. Patients with no other lesions but bone metastasis are excluded. * Recurrent locally or distant advanced NPC (rT3-4N0-3M0-1) * ECOG 0 or 1 * Expected survival ≥ 1 year * Without dysfunction of heart, lung, liver, kidney and hematopoiesis * Patients are voluntary and signed informed consent * No other anti-tumor treatment (including steroid) Exclusion Criteria: * Allergy history to platinum * Use of 5-FU in last 6 months * Had major surgery in last 4 weeks, or the wound has not completely healed * Toxicity from previous treatment is still ≥CTC AE grade 3 * History of other carcinoma in the past 5 years, except for treated carcinoma in situ of cervix, as well as basal cell carcinoma or squamous cell carcinoma of the skin * Dysfunction of heart * Bleeding ≥CTC AE grade 3 * Use of anticoagulant or vitamin K antagonists, except for small dose of aspirin and warfarin for prevention * Patients participated in clinical trials of other drugs within last 4 weeks * Mental illness
References
Publications (0)
Data not yet available
No reference posted for this study.