Clinical trial · Interventional
Induction Chemotherapy and Immunotherapy Combined Radiotherapy With or Without Concurrent Chemotherapy for Stage III-IVa NPC
Prospective Randomized Trial Comparing Induction Chemotherapy and Immunotherapy Combined Radiotherapy With or Without Concurrent Chemotherapy for Stage III-IVa Nasopharyngeal Carcinoma
NCT06095167CI-TRIAL-00070704not yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus immunotherapy with concurrent chemoradiotherapy (CCRT) or RT alone in patients with stage III-IVa nasopharyngeal carcinoma(NPC), in order to confirm the value of Immunotherapy and concurrent chemotherapy in NPC patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| with concurrent cisplatin chemotherapy | Drug | — | UNRESOLVED |
| without concurrent cisplatin chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- The immunotherapy and induction chemotherapy plus RT alone group
- description
- Patients receive Anti-PD-1 Antibody, gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT) alone.
- interventionNames
- Drug: without concurrent cisplatin chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- The immunotherapy and induction chemotherapy plus CCRT group
- description
- Patients receive Anti-PD-1 Antibody, gemcitabine (1000 mg/m² d1,8) , cisplatin (80mg/m² d1) every 3 weeks for three cycles and cisplatin 80-100 mg/m² every 3 weeks for 2 cycles, concurrently with intensity-modulated radiotherapy (IMRT)
- interventionNames
- Drug: with concurrent cisplatin chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type). * Tumor staged as III-Iva(except T3N0M0) (according to the 8th AJCC edition). * No evidence of distant metastasis (M0). * Satisfactory performance status: Karnofsky scale (KPS) ≥ 70. * Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL. * Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN. * Adequate renal function: creatinine clearance ≥ 60 ml/min. * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. * Age \> 65 or \< 18. * Treatment with palliative intent. * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). * Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
References
Publications (0)
Data not yet available
No reference posted for this study.