Nab-paclitaxel Based TPX Neoadjuvant Chemotherapy for NPC Patients: a Dose-escalation Study

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III.

2. Original clinical staged as II-IVa (T2N0 is not included)（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.