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Efficacy and Safety of TPC Induction Chemotherapy Combined With Nimotuzumab and Toripalimab "Immune Sandwich" Regimen Versus Full-Course Immunotherapy for Locally Advanced Nasopharyngeal Carcinoma

NCT07706985 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 566

Last updated 2026-07-16

No results posted yet for this study

Summary

Immunotherapy combined with chemoradiotherapy has become standard care for locally advanced nasopharyngeal carcinoma, yet radiotherapy-induced lymphopenia may impair the efficacy of concurrent PD-1 blockade. Existing evidence supports synergistic anti-tumor activity between the anti-EGFR antibody nimotuzumab and toripalimab. This multicenter, open-label, non-inferiority Phase III trial randomizes eligible stage III-IVA LA-NPC patients 1:1 to two arms. The experimental group receives an "immune sandwich" regimen: TPC induction plus nimotuzumab and toripalimab, concurrent radiotherapy with weekly nimotuzumab only, followed by toripalimab maintenance. The control arm adopts full-course toripalimab throughout induction, concurrent radiotherapy and adjuvant phases. The primary endpoint is 3-year event-free survival, with secondary endpoints covering overall survival, local/distant control rates, objective response rate and treatment-related toxicities. A total of 566 subjects will be enrolled to verify whether the simplified sandwich strategy delivers non-inferior survival with better safety profiles.

Conditions

  • Nasopharyngeal Carcinoma (NPC)

Interventions

DRUG

Toripalimab combined with Nimotuzumab

Induction Chemotherapy Phase： TPC chemotherapy regimen: Nab-paclitaxel: 200 mg/m², intravenous infusion on Day 1；Cisplatin: 60 mg/m², intravenous infusion on Day 1；Capecitabine: 1000 mg/m² orally twice daily on Days 1-14；Each cycle lasts 21 days, for a total of 3 cycles. Toripalimab: 240 mg toripalimab injection, intravenous infusion on Day 0; 21-day cycles for 3 cycles total. Nimotuzumab: 400 mg nimotuzumab, intravenous infusion on Days 0 and 8; 21-day cycles for 3 cycles total. Concurrent Radiotherapy Phase： Toripalimab: 240 mg toripalimab injection via intravenous infusion starting on the first day of radiotherapy, administered every 21 days for 3 cycles. Nimotuzumab: 200 mg nimotuzumab via intravenous infusion once weekly for 6 consecutive weeks, starting on the first day of radiotherapy. Adjuvant Phase： Toripalimab injection 240 mg is administered via intravenous infusion once every 21 days per cycle.

DRUG

Nimotuzumab

Induction Chemotherapy Phase： TPC chemotherapy regimen: Nab-paclitaxel: 200 mg/m², intravenous infusion on Day 1；Cisplatin: 60 mg/m², intravenous infusion on Day 1；Capecitabine: 1000 mg/m² orally twice daily on Days 1-14；Each cycle lasts 21 days, for a total of 3 cycles. Toripalimab: 240 mg toripalimab injection, intravenous infusion on Day 0; 21-day cycles for 3 cycles total. Nimotuzumab: 400 mg nimotuzumab, intravenous infusion on Days 0 and 8; 21-day cycles for 3 cycles total. Concurrent Radiotherapy Phase： Nimotuzumab: 200 mg nimotuzumab via intravenous infusion once weekly for 6 consecutive weeks, starting on the first day of radiotherapy. Adjuvant Phase： Toripalimab injection 240 mg is administered via intravenous infusion once every 21 days per cycle.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2030-07-20
Completion
2033-07-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07706985 on ClinicalTrials.gov