IC Plus Low-dose Radiation Plus Cadonilimab in LANPC
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Low-dose RT plus ICI Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy. |
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 planning target volume) in 30-32 fractions.
Other Names:
Drug: Chemotherapy
Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles
Other Names:
Biological: Immune checkpoint inhibitor
Cadonilimab: 10mg/kg, Q3W, 3 cycles
Other Names:
Radiation: Low-dose radiotherapy
Low-dose radiotherapy will be performed to study group, with the use of IMRT.
|
| Active Comparator: IC+CCRT Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy. |
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 planning target volume) in 30-32 fractions.
Other Names:
Drug: Chemotherapy
Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression free survival [3 years]
From the date of randomization to local or regional recurrence, distant metastasis or any death
Secondary Outcome Measures
- Overall survival [3 years]
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 [3 years]
From the date of randomization to local recurrence or any death
- Regional recurrence-free survival [3 years]
From the date of randomization to regional recurrence or any death
- Distant metastasis-free survival [3 years]
From the date of randomization to distant metastasis or any death
- Acute toxicities [From the start of treatment until 3 months post treatment]
Assessed with CTCAE v5.0
- Late toxicities [3 years post treatment]
Assessed with RTOG/EORTC
- Quality of life score [Through study completion, an average of 3 years]
Assessed with EORTC-Quality of life questionnaire-C30 version 3.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
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All genders, range from 18-70 years old;
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ECOG score 0-1;
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Clinical stage T4N1M0 and T1-4N2-3M0 (AJCC/UICC 8th);
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Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
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No contraindications to chemotherapy, radiotherapy or immunotherapy;
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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);
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Sign the consent form.
Exclusion Criteria:
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Distant metastases;
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Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
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Have or are suffering from other malignant tumors;
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Participating in other clinical trials;
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Pregnancy or lactation;
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Have uncontrolled cardiovascular disease;
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Severe complication, eg, uncontrolled hypertension;
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Mental disorder;
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Drug or alcohol addition;
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Do not have full capacity for civil acts.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Chong Zhao, MD, PhD, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Low-dose RT in NPC