Nasopharyngeal Carcinoma (NPC), Locoregionally Advanced Nasopharyngeal Carcinoma, Adjuvant Therapy
Conditions
Keywords
Nasopharyngeal Carcinoma, Adjuvant therapy, Becotatug Vedotin, Capecitabine
Brief summary
This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to compare the efficacy and safety of Becotatug Vedotin and capecitabine as an adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).
Detailed description
Eligible patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC), staged as T4 N1 M0 or T any N2-3 M0, who have completed curative chemoradiotherapy, will be randomized to either an metronomic capecitabine group or an adjuvant Becotatug Vedotin group. Participants in the experimental group will receive Becotatug Vedotin at a dose of 2.3 mg/kg administered intravenously on Day 1 of each 21-day cycle for a total of three cycles. Participants in the control group will receive metronomic capecitabine at a dose of 650 mg/m² orally twice daily for one year. The primary endpoint is failure-free survival (FFS). Secondary endpoints include overall survival (OS), distant metastasis-free survival (D-MFS), locoregional failure-free survival (LR-FFS), and treatment-emergent adverse events. All efficacy analyses will be performed on an intention-to-treat (ITT) basis. Safety analyses will be conducted in the safety population, defined as all patients who received at least one dose of the assigned study treatment.
Interventions
This group will receive Becotatug Vedotin at a dose of 2.3 mg/kg on day 1 of each 3-week cycle for a total of 3 cycles.
DRUGcapecitabine
This group will receive metronomic capecitabine at a dose of 650 mg/m² orally twice daily for one year.
Sponsors
Kai Hu
Wuzhou Red Cross Hospital
First People's Hospital of Yulin
Guigang People's Hospital
Hainan Cancer Hospital
Affiliated Hospital of North Sichuan Medical College
Affiliated Hospital of Youjiang Medical University for Nationalitie
Lingshan people's Hospital
People's Hospital of Guangxi Zhuang Autonomous Region
LiuZhou People's Hospital
The Third people's hospital of Hechi
the second People's Hospital of qinzhou
Hunan Cancer Hospital
Fujian Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III). 2. Original clinical staged as TanyN2-3M0 or T4N1M0 (according to AJCC 9th edition), with no evidence of distant metastasis. 3. ECOG performance status ≤1. 4. Induction and concurrent chemoradiotherapy with the recommended regimen have been completed. 5. No later than 6 weeks after the completion of the last radiotherapy treatment. 6. Adequate hematologic (neutrophil count \> 1.5×10\^9/L, hemoglobin \> 90g/L and platelet count \> 100×10\^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase \< 2.5×ULN) and renal function (creatinine clearance \> 50 ml/min) 7. Patients must be informed of the investigational nature of this study and give written informed consent. 8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.
Exclusion criteria
1. Patients who could not tolerate or were allergic to Becotatug Vedotin. 2. Patients with severe chronic or active infection that must be treated with systemic antibacterial, antifungal, or antiviral therapy before randomization, including but not limited to tuberculosis infection. 3. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. 4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). 5. Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year. 6. Patients who are known to be intolerant or sensitive to any therapeutic agents. 7. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| failure-free survival | 2 years | calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 2 years | calculated from the date of randomisation to death |
| distant metastasis-free survival | 2 years | calculated from the date of randomisation to the first distant metastasis |
| Locoregional failure-free survival | 2 years | calculated from the date of randomisation to the first locoregional failure |
| treatment-related adverse events (AEs) | 5 years | graded according to NCI CTCAE v5.0 |
Countries
China
Contacts
CONTACTkai hu
Outcome results
None listed