A Phase 3 interventional study of Cadonilimab and Gemcitabine in Nasopharyngeal Carcinoma and Nasopharyngeal Cancer, sponsored by Sun Yat-sen University. Active, not recruiting at 18 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
The trial aimed to compare cadonilimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in high-risk locoregionally-advanced nasopharyngeal carcinoma (LANPC).
The trial plans to enroll patients with non-metastatic stage III-IVA (AJCC 8th, T4N1 or T1-4N2-3) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients were randomly assigned in a 1:1 ratio to receive either gemcitabine-cisplatin induction chemotherapy and concurrent chemoradiotherapy (standard-therapy group) or cadonilimab combined with standard therapy (cadonilimab group). Cadonilimab was administered at a dosage of 10 mg per square meter intravenously once every 3 weeks for up to 17 cycles (3 induction cycles and 14 adjuvant cycles).
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 490 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Cadonilimab 10mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 14 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively.
Drug: Cadonilimab · Drug: Gemcitabine · Drug: Cisplatin · Radiation: Intensity-modulated radiotherapy
Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT.
Drug: Gemcitabine · Drug: Cisplatin · Radiation: Intensity-modulated radiotherapy
Cadonilimab 10mg/kg will be given every 3 weeks for 3 cycles in induction chemotherapy and for 14 cycles in adjuvant chemotherapy, started on day 1 of induction chemotherapy and adjuvant chemotherapy, respectively.
Also known as: PD-1/CTLA-4 bi-specific antibody
Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.
Also known as: GEM
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Also known as: DDP
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
Also known as: IMRT
Failure-free survival (FFS) in intention-to-treat population
multiple endpoint 1: calculated from randomization to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
Time frame: 3 years
Overall survival (OS) in intention-to-treat population
multiple endpoint 2: calculated from randomization to the date of death from any cause.
Time frame: 3 years
Failure-free survival (FFS) in per-protocol population
calculated from randomization to the date of locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
Time frame: 3 years
Overall survival (OS) in per-protocol population
calculated from randomization to the date of death from any cause.
Time frame: 3 years
Locoregional recurrence-free survival (LRRFS)
calculated from randomization to the date of locoregional persistence or 1st locoregional recurrence.
Time frame: 3 years
Distant metastasis-free survival (DMFS)
calculated from randomization to the date of first distant metastasis.
Time frame: 3 years
Adverse events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE V5.0.
Time frame: 3 years
Quality of life (QoL)
The change of QoL from randomization to the start of radiotherapy, the end of radiotherapy, 13-16 weeks after radiotherapy, 2 years and 3 years after randomization. The EORTC QoL questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual.
Time frame: week 1, 20, 40, 64
Failure-free survival (FFS) within different subgroups
analyses for FFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (≤4000copies/ml vs. \>4000copies/ml), different PD-L1 expression levels, age, gender, performance status, T category, N category, and stage (III vs. IVA).
Time frame: 3 years
Tumor response
Evaluation of tumor response as CR, PR, SD, PD, NA by clinicians
Time frame: Through study completion, an average of 1.2 year
Correlation between pre-treatment PD-L1 expression level and FFS
Pre-treatment PD-L1 expression level of tumor cell is evaluated centrally by means of immunohistochemical testing.
Time frame: 3 years
Evaluate failure-free survival in the subgroup of plasma Epstein-Barr virus DNA level
Subgroup analysis
Time frame: 3 years
Evaluate failure-free survival in the subgroup of clinical stage
Subgroup analysis
Time frame: 3 years
Plan to share: No — Complete de-identified patient data set will be submitted onto an online platform.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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