Nasopharyngeal Carcinoma (NPC)Phase 2NCT07303283
Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma
A Phase 2 study testing Becotatug Vedotin in people with Nasopharyngeal Carcinoma (NPC) and Locoregionally Advanced Nasopharyngeal Carcinoma, run by Kai Hu at 1 site in China.
Trial summary
This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to evaluate the efficacy and safety of single-agent Becotatug Vedotin as adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC), Locoregionally Advanced Nasopharyngeal Carcinoma, Adjuvant Therapy
- What is being tested?
- Becotatug Vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 31 Aug 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
- Eligible patients with high-risk locoregionally advanced NPC, defined as AJCC (9th edition) stage T4N1M0 or Tany N2-3M0 disease, or persistent high-risk features after induction chemotherapy (SD, PD, or detectable plasma EBV DNA).
- ECOG performance status ≤1.
- Induction and concurrent chemoradiotherapy with the recommended regimen have been completed.
- No later than 6 weeks after the completion of the last radiotherapy treatment.
- 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)
- Patients must be informed of the investigational nature of this study and give written informed consent.
- 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.
Who cannot join
- Patients who could not tolerate or were allergic to Becotatug Vedotin.
- 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.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year.
- Patients who are known to be intolerant or sensitive to any therapeutic agents.
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
About this study
Official title: Single-agent Becotatug Vedotin as Adjuvant Therapy for High-risk Locoregional Advanced Nasopharyngeal Carcinoma: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 2 Trial
This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to evaluate the efficacy and safety of single-agent Becotatug Vedotin as adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).
Read the detailed description
Eligible patients with high-risk locoregionally advanced NPC, defined as T4N1M0 disease, any T with N2-3M0 disease, stable disease (SD) or progressive disease (PD) after induction chemotherapy, or detectable plasma EBV DNA following induction chemotherapy, who have completed curative-intent chemoradiotherapy, will be randomly assigned to either the adjuvant Becotatug Vedotin group or the observation group. Participants assigned to 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 assigned to the control group will undergo observation alone.
The primary endpoint is event-free survival (EFS). Secondary endpoints include overall survival (OS), distant metastasis-free survival (DMFS), locoregional failure-free survival (LRFFS), and safety. All efficacy analyses will be performed in the intention-to-treat (ITT) population. Safety analyses will be conducted in the safety population, defined as all randomized patients.
- Conditions
- Nasopharyngeal Carcinoma (NPC), Locoregionally Advanced Nasopharyngeal Carcinoma, Adjuvant Therapy
- Being tested
- Becotatug Vedotin
- Keywords
- Nasopharyngeal Carcinoma, Adjuvant therapy, Becotatug Vedotin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug VedotinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Adjuvant Becotatug Vedotin | Experimental | Adjuvant therapy with Becotatug Vedotin Receives: Drug: Becotatug Vedotin |
| observation | No intervention | Clinical follow-up and surveillance only |
What is being measured
The primary outcome is the main question the study is designed to answer.
event-free survival
calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
Measured: 2 years
Secondary outcomes (4)
overall survival
calculated from the date of randomisation to death
Measured: 2 years
distant metastasis-free survival
calculated from the date of randomisation to the first distant metastasis
Measured: 2 years
Locoregional failure-free survival
calculated from the date of randomisation to the first locoregional failure
Measured: 2 years
Treatment-Related Adverse Events
graded according to NCI CTCAE v5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kai Hu
- Sponsor type
- University, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, First People's Hospital of Yulin, Guigang People's Hospital, Hainan Cancer Hospital, Affiliated Hospital of North Sichuan Medical College, Lingshan County People's Hospital, LiuZhou People's Hospital, The Third people's hospital of Hechi, the second People's Hospital of qinzhou, Hunan Cancer Hospital, Fujian Cancer Hospital, Guangxi Nanxishan Hospital, Liuzhou Workers' Hospital, Affiliated Hospital of Youjiang Medical University for Nationalitie
- Responsible party
- Sponsor-investigator, Kai Hu, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303283
- Sponsor's protocol ID
- GuangxiMUHK5
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-agent Becotatug Vedotin as Adjuvant Therapy for High-risk Locoregional Advanced Nasopharyngeal Carcinoma: a Multicentre, Open-label, Parallel-group, Randomised, Controlled, Phase 2 Trial
- ClinicalTrials.gov ID
- NCT07303283
- Acronym / sponsor ID
- GuangxiMUHK5
- Conditions
- Nasopharyngeal Carcinoma (NPC), Locoregionally Advanced Nasopharyngeal Carcinoma, Adjuvant Therapy
- Keywords
- Nasopharyngeal Carcinoma, Adjuvant therapy, Becotatug Vedotin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Kai HuUniversity, hospital or other
- Collaborators
- Wuzhou Red Cross Hospital, First People's Hospital of Yulin, Guigang People's Hospital, Hainan Cancer Hospital, Affiliated Hospital of North Sichuan Medical College, Lingshan County People's Hospital, LiuZhou People's Hospital, The Third people's hospital of Hechi, the second People's Hospital of qinzhou, Hunan Cancer Hospital, Fujian Cancer Hospital, Guangxi Nanxishan Hospital, Liuzhou Workers' Hospital, Affiliated Hospital of Youjiang Medical University for Nationalitie
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2033 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, multicentre, open-label, randomised, controlled trial with a parallel-group design. The study aims to evaluate the efficacy and safety of single-agent Becotatug Vedotin as adjuvant therapy in patients with high-risk locoregionally advanced nasopharyngeal carcinoma (NPC).
Detailed description
Eligible patients with high-risk locoregionally advanced NPC, defined as T4N1M0 disease, any T with N2-3M0 disease, stable disease (SD) or progressive disease (PD) after induction chemotherapy, or detectable plasma EBV DNA following induction chemotherapy, who have completed curative-intent chemoradiotherapy, will be randomly assigned to either the adjuvant Becotatug Vedotin group or the observation group. Participants assigned to 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 assigned to the control group will undergo observation alone.
The primary endpoint is event-free survival (EFS). Secondary endpoints include overall survival (OS), distant metastasis-free survival (DMFS), locoregional failure-free survival (LRFFS), and safety. All efficacy analyses will be performed in the intention-to-treat (ITT) population. Safety analyses will be conducted in the safety population, defined as all randomized patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant Becotatug Vedotin | Experimental | Drug: Becotatug VedotinAdjuvant therapy with Becotatug Vedotin |
| observation | No intervention | –Clinical follow-up and surveillance only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma(WHO II/III).
- Eligible patients with high-risk locoregionally advanced NPC, defined as AJCC (9th edition) stage T4N1M0 or Tany N2-3M0 disease, or persistent high-risk features after induction chemotherapy (SD, PD, or detectable plasma EBV DNA).
- ECOG performance status ≤1.
- Induction and concurrent chemoradiotherapy with the recommended regimen have been completed.
- No later than 6 weeks after the completion of the last radiotherapy treatment.
Key exclusion criteria (7 listed)
- Patients who could not tolerate or were allergic to Becotatug Vedotin.
- 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.
- Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- Interstitial lung disease or pneumonia requiring oral or intravenous steroid therapy within 1 year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Becotatug VedotinThis 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. | Drug | Adjuvant Becotatug Vedotin |
Primary outcome
event-free survival
Time frame: 2 years
calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first
4 secondary outcomes
overall survival
Time frame: 2 years
distant metastasis-free survival
Time frame: 2 years
Locoregional failure-free survival
Time frame: 2 years
Treatment-Related Adverse Events
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Becotatug Vedotin in people with Nasopharyngeal Carcinoma (NPC) and Locoregionally Advanced Nasopharyngeal Carcinoma, run by Kai Hu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact kai hu (+867715359801, hukai@gxmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
event-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.