IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05941741
• Other study ID #: Low-dose RT in NPC
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2024
• Est. completion date: December 2029

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: Chong Zhao, MD, PhD
• Phone: 02087342638
• Email: zhaochong[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: December 2029
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Chemotherapy
• Immune Checkpoint Inhibitor
• Nasopharyngeal Carcinoma
• Radiotherapy

Intervention

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.

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.

Locations

Country	Name	City	State
China	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	From the date of randomization to local or regional recurrence, distant metastasis or any death	3 years
Secondary	Overall survival	From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up	3 years
Secondary	Local recurrence-free survival	From the date of randomization to local recurrence or any death	3 years
Secondary	Regional recurrence-free survival	From the date of randomization to regional recurrence or any death	3 years
Secondary	Distant metastasis-free survival	From the date of randomization to distant metastasis or any death	3 years
Secondary	Acute toxicities	Assessed with CTCAE v5.0	From the start of treatment until 3 months post treatment
Secondary	Late toxicities	Assessed with RTOG/EORTC	3 years post treatment
Secondary	Quality of life score	Assessed with EORTC-Quality of life questionnaire-C30 version 3.0	Through study completion, an average of 3 years

External Links

•   Home Page of Cancer Center, Sun Yat-sen University