OncoMatch/Clinical Trials/NCT07706985
Efficacy and Safety of TPC Induction Chemotherapy Combined With Nimotuzumab and Toripalimab "Immune Sandwich" Regimen Versus Full-Course Immunotherapy for Locally Advanced Nasopharyngeal Carcinoma
Is NCT07706985 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments including Toripalimab combined with Nimotuzumab and Nimotuzumab for nasopharyngeal carcinoma (npc).
Treatment: Toripalimab combined with Nimotuzumab · Nimotuzumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage III, IVA
Excluded: Stage T3-4N0, T3N1
Performance status
ECOG 0–1(Restricted strenuous activity)
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Demographics
Prior therapy
Cannot have received: radiotherapy for nasopharyngeal and cervical lesions
Exception: biopsy
Prior radiotherapy, chemotherapy, or surgery for nasopharyngeal and cervical lesions (excluding biopsy)
Cannot have received: chemotherapy for nasopharyngeal and cervical lesions
Exception: biopsy
Prior radiotherapy, chemotherapy, or surgery for nasopharyngeal and cervical lesions (excluding biopsy)
Cannot have received: surgery for nasopharyngeal and cervical lesions
Exception: biopsy
Prior radiotherapy, chemotherapy, or surgery for nasopharyngeal and cervical lesions (excluding biopsy)
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; Platelet count ≥ 75 × 10⁹/L; Hemoglobin ≥ 9.0 g/dL
Kidney function
Serum Creatinine ≤ 1.5 × ULN, or Creatinine Clearance ≥ 50 mL/min; 24-hour urinary protein quantification < 1 g if urine protein ≥ 2+
Liver function
Total Bilirubin (TBIL) ≤ 2 × ULN; ALT and AST ≤ 5 × ULN; serum albumin ≥ 28 g/L; ALP ≤ 5 × ULN
Adequate organ and bone marrow function as demonstrated by laboratory test results obtained within 7 days prior to enrollment. Hematology: ANC ≥ 1.5 × 10⁹/L; Platelet count ≥ 75 × 10⁹/L; Hemoglobin ≥ 9.0 g/dL; Liver function: TBIL ≤ 2 × ULN; ALT and AST ≤ 5 × ULN; serum albumin ≥ 28 g/L; ALP ≤ 5 × ULN. Renal function: Serum Creatinine ≤ 1.5 × ULN, or Creatinine Clearance ≥ 50 mL/min; 24-hour urinary protein quantification < 1 g if urine protein ≥ 2+. Coagulation function: INR ≤ 2.3, or PT prolongation ≤ 6 seconds
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07706985 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage III or IVA is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages