OncoMatch/Clinical Trials/NCT06301165
TPC Versus GP Induction Chemotherapy for Nasopharyngeal Carcinoma
Is NCT06301165 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including TPC induction chemotherapy and GP induction chemotherapy for nasopharyngeal carcinoma.
Treatment: TPC induction chemotherapy · GP induction chemotherapy — The NCCN guidelines recommend induction chemotherapy followed by concurrent chemoradiotherapy as the standard treatment for locoregionally advanced nasopharyngeal carcinoma (NPC). However, meta-analyses have shown significant survival differences between different induction chemotherapy regimens. How to choose an induction chemotherapy regimen and treatment course that ensures definitive therapeutic effects and low incidence of toxic side effects remains a hot spot in clinical research. Polymeric micellar paclitaxel are an innovative form of paclitaxel drugs, with high penetration and long retention effects, which can enter the vascularly disordered tumor microenvironment through passive targeting and form higher concentrations in tumor tissue. It remains to be investigated whether the TPC (paclitaxel, cisplatin and capecitabine) regimen based on polymeric micellar paclitaxel compared to the current standard first-line induction chemotherapy GP (gemcitabine, cisplatin) regimen can further improve therapeutic effects in high-risk patients with locally advanced disease. There is still a lack of head-to-head studies for comparison. This study aims to compare, through a prospective, parallel-controlled, randomized, open-label, multicenter phase II clinical trial, the TPC induction chemotherapy vs. the GP induction chemotherapy combined with concurrent chemoradiotherapy for the treatment of high-risk locoregionally advanced NPC (T4 or N2-3) in terms of 2-year progression-free survival, overall survival, overall response rate, toxic side effects, etc.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage T4N0-3M0, T1-4N2-3M0 (UICC 8th edition)
Staged as T4N0-3M0 or T1-4N2-3M0 (UICC 8th edition)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiation therapy
Exception: except for non-melanomatous skin cancers outside intended RT treatment volume
History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume)
Cannot have received: chemotherapy
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
Cannot have received: surgery
Exception: except diagnostic
Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes
Lab requirements
Blood counts
leucocyte count ≥ 4×10^9/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×10^9/L
Kidney function
creatinine clearance rate ≥ 60 ml/min or creatinine ≤ 1.5× ULN
Liver function
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and AST or ALT ≤ 1.5 xULN
Adequate bone marrow: leucocyte count ≥ 4×10^9/L, hemoglobin ≥ 90g/L and platelet count ≥ 100×10^9/L; Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) and AST or ALT ≤ 1.5 xULN; Adequate renal function: creatinine clearance rate ≥ 60 ml/min or creatinine ≤ 1.5× ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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