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IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

ConditionsNasopharyngeal CarcinomaImmune Checkpoint InhibitorRadiotherapyChemotherapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intensity Modulated Radiation Therapy

    Radiation

    All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node), 60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions.

  • Chemotherapy

    Drug

    Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles

  • Immune checkpoint inhibitor

    Biological/Vaccine

    Cadonilimab: 10mg/kg, Q3W, 3 cycles

  • Low-dose radiotherapy

    Radiation

    Low-dose radiotherapy will be performed to study group, with the use of IMRT.

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Low-dose RT plus ICIExperimental treatment 4 interventions
Group B: IC+CCRTActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

From the date of randomization to local or regional recurrence, distant metastasis or any death

Time frame
3 years

Secondary outcomes

1

Overall survival

From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up

Time frame
3 years
2

Local recurrence-free survival

From the date of randomization to local recurrence or any death

Time frame
3 years
3

Regional recurrence-free survival

From the date of randomization to regional recurrence or any death

Time frame
3 years
4

Distant metastasis-free survival

From the date of randomization to distant metastasis or any death

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov
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