Back to resultsIC Plus Low-dose Radiation Plus Cadonilimab in LANPC
Primary Purpose
Nasopharyngeal Carcinoma, Immune Checkpoint Inhibitor, Radiotherapy
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Intensity Modulated Radiation Therapy
Chemotherapy
Immune checkpoint inhibitor
Low-dose radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low-dose RT plus ICI
IC+CCRT
Arm Description
Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy.
Outcomes
Primary Outcome Measures
Progression free survival
From the date of randomization to local or regional recurrence, distant metastasis or any death
Secondary Outcome Measures
Overall survival
From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
Local recurrence-free survival
From the date of randomization to local recurrence or any death
Regional recurrence-free survival
From the date of randomization to regional recurrence or any death
Distant metastasis-free survival
From the date of randomization to distant metastasis or any death
Acute toxicities
Assessed with CTCAE v5.0
Late toxicities
Assessed with RTOG/EORTC
Quality of life score
Assessed with EORTC-Quality of life questionnaire-C30 version 3.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05941741
Brief Title
IC Plus Low-dose Radiation Plus Cadonilimab in LANPC
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma, Immune Checkpoint Inhibitor, Radiotherapy, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low-dose RT plus ICI
Arm Type
Experimental
Arm Description
Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
Arm Title
IC+CCRT
Arm Type
Active Comparator
Arm Description
Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy.
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiation Therapy
Other Intervention Name(s)
IMRT
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Induction chemotherapy, Concurrent chemotherapy, Gemcitabine, Cisplatin
Intervention Description
Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles
Intervention Type
Biological
Intervention Name(s)
Immune checkpoint inhibitor
Other Intervention Name(s)
Cadonilimab, AK104, PD-1/CTLA-4 inhibitor
Intervention Description
Cadonilimab: 10mg/kg, Q3W, 3 cycles
Intervention Type
Radiation
Intervention Name(s)
Low-dose radiotherapy
Intervention Description
Low-dose radiotherapy will be performed to study group, with the use of IMRT.
Primary Outcome Measure Information:
Title
Progression free survival
Description
From the date of randomization to local or regional recurrence, distant metastasis or any death
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
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
Title
Local recurrence-free survival
Description
From the date of randomization to local recurrence or any death
Time Frame
3 years
Title
Regional recurrence-free survival
Description
From the date of randomization to regional recurrence or any death
Time Frame
3 years
Title
Distant metastasis-free survival
Description
From the date of randomization to distant metastasis or any death
Time Frame
3 years
Title
Acute toxicities
Description
Assessed with CTCAE v5.0
Time Frame
From the start of treatment until 3 months post treatment
Title
Late toxicities
Description
Assessed with RTOG/EORTC
Time Frame
3 years post treatment
Title
Quality of life score
Description
Assessed with EORTC-Quality of life questionnaire-C30 version 3.0
Time Frame
Through study completion, an average of 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chong Zhao, MD, PhD
Phone
02087342638
Email
zhaochong@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jingjing Miao, MD
Phone
+8613631355201
Email
miaojj@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chong Zhao, MD, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.sysucc.org.cn
Description
Home Page of Cancer Center, Sun Yat-sen University
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IC Plus Low-dose Radiation Plus Cadonilimab in LANPC
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