Overview

IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

Status:
Recruiting
Trial end date:
2029-12-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
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.