Nasopharyngeal Cancinoma (NPC)Phase 2NCT07496190
Becotatug Vedotin for LA-NPC With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy
A Phase 2 study testing Becotatug vedotin in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Becotatug vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 10 Feb 2034
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation and written informed consent must be signed.
- Age between 18 and 70 years, male or non-pregnant female.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Stage Any T N2-3 or T4N1 (AJCC 9th edition), with no distant metastasis, and previously untreated nasopharyngeal carcinoma.
- Efficacy after 3 cycles of induction immunochemotherapy assessed as stable disease (SD) or progressive disease (PD) by nasopharyngoscopy and contrast-enhanced MRI of the nasopharynx and neck.
- ECOG performance status score of 0 or 1.
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- Adequate hematological function: Hemoglobin (HGB)≥90g/L, White Blood Cell (WBC) ≥ 4.010^9/L, and Platele (PLT) ≥10010^9/L.
- Adequate hepatic function: ALT and AST≤2.5Upper Limit of Normal (ULN), total bilirubin ≤2.0ULN, and serum albumin≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
- International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 *ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).
Who cannot join
- Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
- Pathological diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
- Patients who have previously received radiotherapy or systemic chemotherapy.
- Women who are pregnant or breastfeeding, or individuals of childbearing potential who are not using effective contraception.
- HIV positive.
- History of other malignancies (except for cured basal cell carcinoma or cervical carcinoma in situ).
- Patients who have previously received immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qi Yang contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Pei-Yu Huang, +86-20-87343379, huangpy@sysucc.org.cn
About this study
Official title: Becotatug Vedotin for Locoregionally Advanced Nasopharyngeal Carcinoma With a Suboptimal Response to Induction Chemotherapy Combined With Immunotherapy: A Prospective, Single-Arm, Phase II Trial
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
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Becotatug vedotin
- Keywords
- high-risk locally advanced nasopharyngeal carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug vedotinDrug
Becotatug vedotin during concurrent radiotherapy and the adjuvant phase
Becotatug vedotinDrug
- Induction Chemotherapy (TPP Regimen) Docetaxel 75 mg/m² d1 + Cisplatin (DDP) 75 mg/m² d1 + PD-1 inhibitor , administered every 3 weeks for a total of 3 cycles.
- Concurrent Radiotherapy (Becotatug vedotin + IMRT) Concurrent radiotherapy commences 3 weeks after the completion of induction chemotherapy: Becotatug vedotin 2.3 mg/kg d1, starting on the first day of radiotherapy, administered every 3 weeks during the radiotherapy period for a total of 3 cycles. The radiotherapy technique employed is intensity-modulated radiotherapy (IMRT).
- Adjuvant Therapy
Adjuvant therapy commences 4-6 weeks after the completion of radiotherapy:
Becotatug vedotin 2.3 mg/kg d1, administered every 3 weeks for a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | 1. Induction Chemotherapy (TPP Regimen) Docetaxel 75 mg/m² d1 + Cisplatin (DDP) 75 mg/m² d1 + PD-1 inhibitor , administered every 3 weeks for a total of 3 cycles.
2. Concurrent Radiotherapy (Becotatug vedotin + IMRT)
Concurrent radiotherapy commences 3 weeks after the completion of induction chemotherapy:
Becotatug vedotin 2.3 mg/kg d1, starting on the first day of radiotherapy, administered every 3 weeks during the radiotherapy period for a total of 3 cycles.
The radiotherapy technique employed is intensity-modulated radiotherapy (IMRT).
3. Adjuvant Therapy
Adjuvant therapy commences 4-6 weeks after the completion of radiotherapy:
Becotatug vedotin 2.3 mg/kg d1, administered every 3 weeks for a total of 3 cycles. Receives: Drug: Becotatug vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival is calculated from the date of treatment initiation to the date of documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.
Measured: 3 years
Secondary outcomes (5)
Overall survival
Overall survival is calculated from the date of treatment initiation to death from any cause.
Measured: 3 years
Locoregional recurrence-free survival
Locoregional recurrence-free survival is calculated from the date of treatment initiation to the date of documented locoregional recurrence or death from any cause.
Measured: 3 years
Distant metastasis-free survival
Distant metastasis-free survival is calculated from the date of treatment initiation to the date of documented distant metastasis or death from any cause.
Measured: 3 years
Incidence of acute toxicity as assessed by CTCAE v5.0
Acute adverse events (those that occurred within 1 year of randomisation) are graded according to the Common Terminology Criteria for Adverse Events (version 5.0).
Measured: 3 years
Incidence of late toxicity as assessed by the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group
Late adverse events (those occurring >1 year after randomisation) are graded according to the Late Radiation Morbidity Scoring Scheme of the Radiation Therapy Oncology Group.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start10 Feb 2026
- Primary completion10 Feb 2032 (estimated)
- Study completion10 Feb 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Yu Huang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496190
- Sponsor's protocol ID
- 2025-FXY-486
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No