TPC versus GP induction chemotherapy plus concurrent chemoradiotherapy for high-risk locoregionally advanced nasopharyngeal carcinoma: a randomized phase II multi-center trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200061378

Enrollment

Unknown

Registered

2022-06-22

Start date

2022-08-01

Completion date

Unknown

Last updated

2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nasopharyngeal carcinoma

Interventions

Experimental arm:TPC induction chemotherapy plus concurrent chemoradiotherapy

Control arm:GP induction chemotherapy plus concurrent chemoradiotherapy

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)Histologically confirmed as WHO type II or III nasopharyngeal carcinoma); (2)Clinical stage: T4N1-3M0 or T1-4N2-3M0(UICC 8th edition); (3)With no previous anti-tumor history; (4)With no history of other malignancy; (5)Male or female, aged 18-65; (6)Normal hepatic functions: TBIL, AST, ALT = 2.0×ULN; (7)Normal nephritic functions: CREAT < 1.5×ULN; Ccr = 60 ml/min (Cockcroft-Gault formula); (8)Normal hematological functions: WBC=4×109/L, PLT=100×109/L HGB=90g/L; (9)The main organs function well; (10)ECOG score:0-1; (11)Signed the Informed Consent Form.

Exclusion criteria

Exclusion criteria: (1)Had previous anti-tumor history; (2)Showed with signs of metastasis before treatment; (3)Pregnant or lactating women; (4)Refused to sign the Informed Consent Form; (5)Refused to complete the regular follow-up visits; (6)Have participated in other drug clinical trials; (7)Potential to be allergic to the treatment drugs; (8)With severe or uncontrolled infections or other diseases; (9)The main organs dysfunction; (10)A variety of factors (such as inability to swallow, postgastrectomy, chronic diarrhea, and intestinal obstruction) that affect the oral and absorption of drugs; (11)Have a history of immunodeficiency disorders; (12)Patients with a treatment history of other malignancies.

Design outcomes

Primary

Measure	Time frame
Progression-free survival;	—

Secondary

Measure	Time frame
Overall survival;Locoregional recurrence-free survival;Distant metastasis-free survival;Tumor response;Tolerance and compliance;Acute and late toxicities;	—

Countries

CHINA

Contacts

Public ContactHaiqiang Mai

maihq@mail.sysu.edu.cn+86 13570027338

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026