Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma

Kai Hu

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Locoregionally Advanced Nasopharyngeal Carcinoma; Adjuvant Therapy; Nasopharyngeal Carcinoma (NPC)

Treatments: Drug: capecitabine; Drug: Becotatug Vedotin

Study type: Interventional

Funder types: Other

Identifiers

NCT07303283

GuangxiMUHK5

Details and patient eligibility

About

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).

Full 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 adjuvant capecitabine group or an adjuvant Becotatug Vedotin group. The experimental group will receive Becotatug Vedotin at a dose of 2.3 mg/kg on day 1 of each 3-week cycle for 3 cycles. The control group will receive capecitabine at 1000 mg/m² twice daily on days 1-14 of each 3-week cycle for 8 cycles. 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.

Enrollment: 227 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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227 participants in 2 patient groups

Adjuvant Becotatug Vedotin

Experimental group

Description:

Adjuvant therapy with Becotatug Vedotin

Treatment:

Drug: Becotatug Vedotin

control

Other group

Description:

Adjuvant therapy with capecitabine

Treatment:

Drug: capecitabine