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Trial Title:
IC Plus Low-dose Radiation Plus Cadonilimab in LANPC
NCT ID:
NCT05941741
Condition:
Nasopharyngeal Carcinoma
Immune Checkpoint Inhibitor
Radiotherapy
Chemotherapy
Conditions: Official terms:
Carcinoma
Nasopharyngeal Carcinoma
Cisplatin
Gemcitabine
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Intensity Modulated Radiation Therapy
Description:
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.
Arm group label:
IC+CCRT
Arm group label:
Low-dose RT plus ICI
Other name:
IMRT
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy:
cisplatin, Q3W, 2-3 cycles
Arm group label:
IC+CCRT
Arm group label:
Low-dose RT plus ICI
Other name:
Induction chemotherapy
Other name:
Concurrent chemotherapy
Other name:
Gemcitabine
Other name:
Cisplatin
Intervention type:
Biological
Intervention name:
Immune checkpoint inhibitor
Description:
Cadonilimab: 10mg/kg, Q3W, 3 cycles
Arm group label:
Low-dose RT plus ICI
Other name:
Cadonilimab
Other name:
AK104
Other name:
PD-1/CTLA-4 inhibitor
Intervention type:
Radiation
Intervention name:
Low-dose radiotherapy
Description:
Low-dose radiotherapy will be performed to study group, with the use of IMRT.
Arm group label:
Low-dose RT plus ICI
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Center, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Chong Zhao, M.D
Phone:
02087342638
Email:
zhaochong@sysucc.org.cn
Facility:
Name:
The First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Min Kang, MD
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jingao Li
Start date:
January 10, 2024
Completion date:
December 2029
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05941741
http://www.sysucc.org.cn
