Clinical trial · Interventional
The Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Nasopharyngeal Carcinoma
A Prospective Phase II Clinical Trial of Paclitaxel (Albumin-bound) Combined With Cisplatin, PD-1 Inhibitors and IMRT in the Treatment of Locally Advanced Nasopharyngeal Carcinoma
NCT04769076CI-TRIAL-00050335unknownPhase 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 in to observe the effectiveness and safety of paclitaxel (albumin-bound type) combined with cisplatin, PD-1 inhibitor and IMRT in the treatment of locally 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 |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel（Albumin-bound） | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel(Album-bound)
- description
- Subjects will receive neoadjuvant therapy with paclitaxel (albumin-bound) combined with cisplatin and PD-1 inhibitor (sintilimab) as well as radical concurrent radiotherapy and chemotherapy.
- interventionNames
- Combination Product: Paclitaxel（Albumin-bound）
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 1 month after the end of all treatments
- description
- According to European Solid Tumor Efficacy Evaluation Standard (RECIST)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma * The stage is Ⅲ-ⅣA (UICC 8th edition) * Initial treatment patients without anti-tumor therapy * No history of other malignant tumors * Male or female, aged 18\~70 years old * Sufficient liver and kidney function: total bilirubin ≤ upper limit of normal (ULN); AST and ALT ≤ 2.5 times ULN; alkaline phosphatase ≤ 5 times ULN; creatinine clearance ≥ 80 mL/min * Sufficient blood function: neutrophil count (ANC) ≥2×109/L, platelet count ≥100×109/L and hemoglobin ≥9 g/dL * No serious heart, lung, liver, kidney and other important organ dysfunction * Karnofsky score ≥70 points * No autoimmune diseases * Sign informed consent Exclusion Criteria: * Has performed anti-tumor treatment, including chemotherapy, radiotherapy, and surgery * Discovery of distant metastases before treatment * Receive live attenuated vaccine within 4 weeks before enrollment or plan to receive live attenuated vaccine during the study period * Active, known or suspected autoimmune diseases * Known history of primary immunodeficiency * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation * Women who are pregnant or breastfeeding * Disagree to sign the informed consent form * Patients who cannot cooperate with regular follow-up due to psychological, social, family and geographic reasons * Simultaneously accept experimental treatment of other clinical research (in the treatment period of clinical research) * Known allergic to possible chemotherapy drugs * Accompanied by serious uncontrollable infections or medical diseases * Major organ dysfunction, such as decompensated heart, lung, kidney, and liver failure, unable to tolerate radiotherapy and chemotherapy * Laboratory examination: total bilirubin\>upper limit of normal (ULN); AST and/or ALT\>1.5 times ULN and accompanied by alkaline phosphatase\>2.5 times ULN
References
Publications (0)
Data not yet available
No reference posted for this study.