Clinical trial · Interventional
IC Plus Low-dose Radiation Plus Cadonilimab in LANPC
Induction Chemotherapy Combined With Low-dose Radiation Plus Cadonilimab in Loco-regionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Open-label, Randomized Controlled Phase III Clinical Trial
- 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)
This is a multi-center, open-label, randomized controlled phase III clinical trial in primary diagnosed loco-regionally advanced nasopharyngeal carcinoma (NPC) patients. The purpose of this study is to evaluate the efficacy of induction chemotherapy (IC) combined with low-dose radiation and immune checkpoint inhibitor (ICI) followed by concurrent chemoradiotherapy (CCRT) versus IC+CCRT, and compare the treatment-related adverse events and quality of life in two groups.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitor | — | UNRESOLVED | — |
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Immune checkpoint inhibitor | Biological | Immune Checkpoint Inhibitor | ALIAS |
| Intensity Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
| Low-dose radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low-dose RT plus ICI
- description
- Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
- interventionNames
- Radiation: Intensity Modulated Radiation Therapy
- Drug: Chemotherapy
- Biological: Immune checkpoint inhibitor
- Radiation: Low-dose radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- IC+CCRT
- description
- Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy.
- interventionNames
- Radiation: Intensity Modulated Radiation Therapy
- Drug: Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III); * All genders, range from 18-70 years old; * ECOG score 0-1; * Clinical stage T4N1M0 and T1-4N2-3M0 (AJCC/UICC 8th); * Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy); * No contraindications to chemotherapy, radiotherapy or immunotherapy; * Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase \< 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); * Sign the consent form. Exclusion Criteria: * Distant metastases; * Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma; * Have or are suffering from other malignant tumors; * Participating in other clinical trials; * Pregnancy or lactation; * Have uncontrolled cardiovascular disease; * Severe complication, eg, uncontrolled hypertension; * Mental disorder; * Drug or alcohol addition; * Do not have full capacity for civil acts.
References
Publications (0)
Data not yet available