Clinical trial · Interventional
Nab-paclitaxel Based TPX Neoadjuvant Chemotherapy for NPC Patients: a Dose-escalation Study
Nab-paclitaxel Plus Cisplatin and Capecitabine as Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Locoregionally Advanced Nasopharyngeal Carcinoma: a Phase I Dose-escalation Study
- 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)
Neoadjuvant chemotherapy followed by concurrent chemoradiation (CCRT) has been recommended in the treatment of locoregionally-advanced nasopharyngeal carcinoma (NPC), with docetaxel, cisplatin (DDP) and 5-fluorouracil (5-Fu) shown to be an effective regimen. Capecitabine is the precursor drug of 5-fluorouracil, and has been used in replace of 5-fluorouracil in NPC patients. Nab-paclitaxel (Nab-PTX) is a novel albumin-bound paclitaxel with a superior therapeutic index to docetaxel. We sought to find out the efficacy of Nab-PTX in three-drug triplet (Nab-PTX, DDP and capecitabine) and decide the best administration dose of Nab-PTX.
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 Cancer | Malignant Nasopharyngeal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nab paclitaxel | Drug | Nab-paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TPX neoadjuvant chemotherapy +CCRT
- description
- Patients receive neoadjuvant chemotherapy with Nab-PTX (150/175/200/225/250 mg/m2, D1) , cisplatin (75 mg/m2, D1) and capecitabine (1000 mg/m2, BID, D1-14) every three weeks for three cycles before radiotherapy, then followed by concurrent IMRT and cisplatin (100 mg/m2) concurrent every three weeks during radiotherapy (D1, D22, D43 of RT)
- interventionNames
- Drug: Nab paclitaxel
Primary outcomes (2)
- measure
- Maximum tolerated dose
- timeFrame
- At the end of each cycle (each cycle is 21 days)
- description
- If more than one-third of patients in a given cohort experienced a dose-limiting toxicity (DLT), enrollment will be stopped and the dose used in the previous cohort will be designated as the maximum tolerated dose
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III. 2. Original clinical staged as III-IVa （according to the 8th AJCC edition). 3. No evidence of distant metastasis (M0). 4. Male and no pregnant female. 5. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1. 6. WBC ≥ 4×109 /L and PLT ≥100×109 /L and HGB ≥90 g/L. 7. With normal liver function test (ALT/AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN). 8. With normal renal function test (Creatinine Clearance ≥ 60 ml/min ). Exclusion Criteria: 1. Patients have evidence of relapse or distant metastasis. 2. Histologically confirmed keratinizing squamous cell carcinoma (WHO I). 3. Receiving radiotherapy or chemotherapy previously. 4. The presence of uncontrolled life-threatening illness. 5. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. 6. Receiving other ways of anti-cancer therapy. 7. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
References
Publications (1)
- DERIVEDYu-Chen, Luo MJ, Liu RP, Jin J, Deng SW, Tang LQ, Li XY, Liu LT, Luo DH, Sun R, Liu SL, Li JB, Liu Q, Wang P, Chen QY, Mai HQ, Guo SS. Phase I dose-escalation study of nab-paclitaxel combined with cisplatin and capecitabin as induction chemotherapy followed by concurrent chemoradiotherapy in patients with nasopharyngeal carcinoma. Radiother Oncol. 2024 Feb;191:110051. doi: 10.1016/j.radonc.2023.110051. Epub 2023 Dec 21. PMID 38135184