Toripalimab Vs. Placebo Wtih GP Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Summary

The main questions it aims to answer are:

1. Does the combination of GP induction chemotherapy and toripalimab improve the 3-year progression-free survival (PFS) compared to GP induction chemotherapy with placebo?
2. What are the differences in CR after induction therapy, 3-year overall survival (OS), locoregional progression, and distant progression between the two groups?
3. What are the differences in safety between the two groups?
4. Are there predictive biomarkers of therapeutic efficacy, such as changes in EBV DNA or immune parameters, that correlate with treatment outcomes?

Researchers will compare the GP + toripalimab group with the GP + placebo group to see if the toripalimab combination shows superior efficacy.

Participants will:

Receive either GP chemotherapy with toripalimab or GP chemotherapy with placebo as induction therapy.

Undergo concurrent chemoradiotherapy ± adjuvant metronomic capecitabine following induction therapy.

Be monitored closely for safety and efficacy outcomes.

Conditions

• Nasopharyngeal Carcinoma (NPC)

Interventions

DRUG

TORIPALIMAB INJECTION (JS001 ) combine with GP chemotherapy

Drug: Toripalimab 240mg will be given every 3 weeks for 3 cycles, started on day 1 of induction chemotherapy. Other Names: JS001 PD-1 antibody Drug: Gemcitabine 1000mg/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation. Drug: Cisplatin Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 3 cycles during radiation Other Names: DDP Radiation: intensity-modulated radiotherapy Definitive intensity-modulated radiotherapy (IMRT) of 70 Gy will be given in 33 fractions. Other Names: IMRT

DRUG

GP plus placebo induction therapy

Drug: Placebo 240mg will be given every 3 weeks for 3 cycles, started on day 1 of induction chemotherapy. Drug: Gemcitabine 1000mg/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation. Drug: Cisplatin Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 3 cycles during radiation Other Names: DDP Radiation: intensity-modulated radiotherapy Definitive intensity-modulated radiotherapy (IMRT) of 70 Gy will be given in 33 fractions. Other Names: IMRT

Sponsors & Collaborators

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Guangxi Medical University Cancer Center

  collaborator UNKNOWN

• Affiliated Hospital of Guangdong Medical University

  collaborator OTHER

• Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

  collaborator OTHER

• The University of Hong Kong-Shenzhen Hospital

  collaborator OTHER

• Hunan Cancer Hospital

  collaborator OTHER

• The Affiliated Cancer Hosipital of Guizhou Meidical University

  collaborator UNKNOWN

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Fujian Cancer Hospital

  collaborator OTHER_GOV

• Sun Yat-sen University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-17

Primary Completion

2030-01-01

Completion

2032-01-01

Countries

• China

Study Locations