Actively Recruiting
Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy
Led by Sun Yat-sen University · Updated on 2026-04-13
59
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Based on the short-term efficacy and plasma EBV DNA levels following immuno-induction chemotherapy, patients with locally advanced nasopharyngeal carcinoma who derive different benefits from this treatment can be identified. For high-risk patients who do not respond to immuno-induction chemotherapy (defined as EBV DNA \>0 copies/mL or imaging response evaluation showing SD/PD after immuno-induction chemotherapy), the addition of becotatug vedotin, which has a different mechanism of action, during concurrent radiotherapy and the adjuvant phase may improve patient survival. Based on the above research and background, the investigators plan to conduct the first prospective, single-arm, phase II clinical study of becotatug vedotin in patients with locally advanced nasopharyngeal carcinoma who are suboptimal responsive to immuno-induction chemotherapy, aiming to obtain sufficient evidence-based medical data to provide an additional treatment option for the concurrent and adjuvant phases of nasopharyngeal carcinoma.
CONDITIONS
Official Title
Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 70 years, male or non-pregnant female
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (WHO type II or III)
- Stage Any T N2-3 or T4N1 (AJCC 9th edition) without distant metastasis, untreated
- Stable disease or progressive disease after 3 cycles of induction immunochemotherapy
- ECOG performance status score of 0 or 1
- Adequate hematological function: Hemoglobin 9 g/L, White Blood Cell 4.0^9/L, Platelets 10^9/L
- Adequate liver function: ALT and AST 2.5x Upper Limit of Normal, total bilirubin 2.0x ULN, serum albumin 30 g/L
- Adequate kidney function: Serum creatinine 1.5x ULN or creatinine clearance 60 mL/min
- INR and APTT 1.5x ULN unless on anticoagulant with parameters in therapeutic range
You will not qualify if you...
- Recurrent or distant metastatic nasopharyngeal carcinoma
- Keratinizing squamous cell carcinoma (WHO Type I)
- Prior radiotherapy or systemic chemotherapy
- Pregnant or breastfeeding women or those not using effective contraception
- HIV positive
- History of other cancers except cured basal cell carcinoma or cervical carcinoma in situ
- Prior treatment with immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
P
Pei-Yu Huang
CONTACT
Q
Qi Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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