IC Plus Low-dose Radiation Plus Cadonilimab in LANPC (NCT05941741) | Clinical Trial Compass
RecruitingPhase 3
IC Plus Low-dose Radiation Plus Cadonilimab in LANPC
China380 participantsStarted 2024-01-10
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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.