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Recruiting NCT05941741

IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

Phase III Interventional Nasopharyngeal Carcinoma Immune Checkpoint Inhibitor Radiotherapy Chemotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intensity Modulated Radiation Therapy, Chemotherapy, Immune checkpoint inhibitor, Low-dose radiotherapy.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma, Immune Checkpoint Inhibitor, Radiotherapy, Chemotherapy. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Induction Chemotherapy Combined With Low-dose Radiation Plus Cadonilimab in Loco-regionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Open-label, Randomized Controlled Phase III Clinical Trial

Overview

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.

Interventions

  • Radiation Intensity Modulated Radiation Therapy
    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
  • Drug Chemotherapy
    Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles
  • Biological Immune checkpoint inhibitor
    Cadonilimab: 10mg/kg, Q3W, 3 cycles
  • Radiation Low-dose radiotherapy
    Low-dose radiotherapy will be performed to study group, with the use of IMRT.

Primary outcome measures

  • Progression free survival [Time frame: 3 years]
Secondary outcome measures (7)
  • Overall survival [Time frame: 3 years]
  • Local recurrence-free survival [Time frame: 3 years]
  • Regional recurrence-free survival [Time frame: 3 years]
  • Distant metastasis-free survival [Time frame: 3 years]
  • Acute toxicities [Time frame: From the start of treatment until 3 months post treatment]
  • Late toxicities [Time frame: 3 years post treatment]
  • Quality of life score [Time frame: Through study completion, an average of 3 years]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Cancer Center, Sun Yat-sen University — Guangzhou
  • The First Affiliated Hospital of Guangxi Medical University — Nanning
  • Jiangxi Cancer Hospital — Nanchang

Identifiers

NCT: NCT05941741 · Low-dose RT in NPC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗