Overview
IC Plus Low-dose Radiation Plus Cadonilimab in LANPC
Status:
Recruiting
Recruiting
Trial end date:
2029-12-01
2029-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Sun Yat-sen UniversityTreatments:
Cisplatin
Gemcitabine
Immune Checkpoint Inhibitors
Criteria
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.