Nasopharyngeal Carcinoma (NPC)Phase 3NCT07459296
Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC
A Phase 3 study testing Becotatug Vedotin, Sintilimab and Cisplatin in people with Nasopharyngeal Carcinoma (NPC), run by First Affiliated Hospital of Guangxi Medical University at 1 site in China.
Trial summary
This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Becotatug Vedotin, Sintilimab and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2026to 1 Apr 2032
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the study and sign the informed consent form in writing.
- Aged 18-70 years, male or non-pregnant female.
- Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).
- Staged as anyT N2-3 or T4N1 (9th AJCC/UICC staging) without distant metastasis.
- ECOG performance status score of 0-1.
- Hemoglobin (HGB) ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, and platelet (PLT) count ≥ 100×10⁹/L.
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- Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN.
- Normal renal function: Creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft-Gault formula).
- Sexually active females of childbearing potential must agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug. Males who have sexual relations with females of childbearing potential must also agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug.
Who cannot join
- Aged > 70 years or < 18 years.
- Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
- Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I).
- Patients who have previously received radiotherapy or systemic chemotherapy.
- Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA > 1000 copies/mL or 200 IU/mL.
- Positive for hepatitis C virus antibody (anti-HCV).
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- Patients with active autoimmune diseases, excluding type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy, and skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
- Patients who received systemic glucocorticoids (equivalent to prednisone > 10 mg/day) or other immunosuppressive therapy within 28 days prior to signing the informed consent form. Patients who received systemic glucocorticoids equivalent to prednisone ≤ 10 mg/day, inhaled or topical glucocorticoids are eligible for enrollment.
- Patients with a history of active tuberculosis within the past year; patients with active tuberculosis that has been adequately treated for more than one year are eligible for enrollment. Patients with a history of other malignant tumors (except cured basal cell carcinoma or carcinoma in situ of the cervix).
- Patients with a history of interstitial lung disease.
- Patients who received live vaccines within 30 days prior to signing the informed consent form or plan to receive live vaccines in the near future.
- Pregnant or lactating females.
- Patients with a history of other malignant tumors within the past 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer.
- Patients with known hypersensitivity to any component of gemcitabine, cisplatin, becotatug vedotin, or sintilimab.
- Patients with known history of HIV infection.
- Any other conditions deemed by the investigator to potentially affect the patient's ability to sign the informed consent form, cooperate with and participate in the study, or interfere with the interpretation of results, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illnesses, or family/social factors.
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, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Min Kang, MD, +86-771-5356509, kangmin@gxmu.edu.cn
About this study
Official title: Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：A Multicenter, Randomized, Controlled, Phase 3 Trial
This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), adverse events, and quality of life.
Read the detailed description
This is a multicenter, randomized, controlled phase III clinical study targeting patients with high-risk locally advanced nasopharyngeal carcinoma (stage T1-4N2-3M0 or T4N1M0 per the 9th AJCC/UICC staging system), with a planned enrollment of 266 patients who will be randomized 1:1 into an experimental group and a control group under an open-label, stratified randomization design. The primary endpoint of the study is 3-year event-free survival (EFS), and the secondary endpoints include efficacy measures such as overall survival and locoregional recurrence-free survival, as well as safety and quality of life assessments; additionally, the study explores the predictive value of efficacy biomarkers including EGFR expression and combined positive score (CPS). The experimental group is administered neoadjuvant therapy with becotatug vedotin plus sintilimab for 3 cycles, followed by concurrent chemoradiotherapy with cisplatin combined with adjuvant sintilimab therapy for 9 cycles, while the control group receives induction chemotherapy with gemcitabine plus cisplatin (GP regimen) for 3 cycles followed by concurrent chemoradiotherapy with cisplatin. Intensity-modulated radiation therapy (IMRT) is uniformly adopted for all patients in both groups, with standardized target volume doses and normal organ dose constraints defined. The study has also formulated detailed protocols for drug dose adjustment and toxicity monitoring; treatment-related adverse events are graded and managed in accordance with the NCI-CTCAE v5.0 and RTOG/EORTC criteria, and the EORTC QLQ-C30 scale is used to evaluate patients' quality of life. The study aims to verify that the innovative treatment regimen of becotatug vedotin combined with sintilimab yields superior efficacy with a manageable safety profile compared with the conventional GP induction chemotherapy followed by chemoradiotherapy in patients with high-risk locally advanced nasopharyngeal carcinoma, thereby providing a novel treatment option for this patient population and supplementing high-level evidence-based medical evidence. Meanwhile, it explores relevant biomarkers to lay a foundation for individualized treatment.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Becotatug Vedotin, Sintilimab, Cisplatin, intensity-modulated radiotherapy, Gemcitabine (GEM)
- Keywords
- Nasopharyngeal Carcinoma, Becotatug Vedotin, Sintilimab, Concurrent Chemoradiotherapy
- 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
Becotatug vedotin 2.3 mg/kg will be given on Day 1 of induction therapy, once every 3 weeks for a total of 3 cycles.
SintilimabDrug
In the induction treatment phase, sintilimab 200 mg will be administered on Day 1 of each induction cycle, once every 3 weeks, for a total of 3 cycles. In the adjuvant treatment phase, sintilimab 200 mg will be given on Day 1, initiated 3 weeks after the completion of radiotherapy, once every 3 weeks, for a total of 9 cycles.
CisplatinDrug
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
intensity-modulated radiotherapyRadiation
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions
Gemcitabine (GEM)Drug
Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.
CisplatinDrug
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation
| Study group | Role | What they receive |
|---|---|---|
| Becotatug Vedotin followed by CCRT plus Sintilimab | Experimental | Patients will receive Becotatug Vedotin induction therapy followed by CCRT combined with neoadjuvant and adjuvant sintilimab Receives: Drug: Becotatug Vedotin; Drug: Sintilimab; Drug: Cisplatin; Radiation: intensity-modulated radiotherapy |
| Induction Chemotherapy followed by CCRT | Active comparator | Patients will receive gemcitabine plus cisplatin induction chemotherapy followed by CCRT Receives: Drug: Cisplatin; Radiation: intensity-modulated radiotherapy; Drug: Gemcitabine (GEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-free survival (EFS)
The time interval from randomization to the first treatment failure or the last follow-up if there is no treatment failure. Treatment failure is defined as local/cervical residual disease 16 weeks after radiotherapy, local/cervical recurrence, distant metastasis, or death due to any cause,whichever occurred first.
Measured: 3 years
Secondary outcomes (6)
Overall survival (OS)
The time interval from randomization to the date of death from any cause.
Measured: 3 years
Distant metastasis-free survival (DMFS)
The time interval from randomization to the date of first distant metastasis, or death from any cause, whichever occurred first.
Measured: 3 years
Locoregional recurrence-free survival (LRFS)
The time interval randomization to the date of locoregional persistence, 1st locoregional recurrence, or death from any cause, whichever occurred first.
Measured: 3 years
Adverse events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE V5.0.
Measured: 3 years
Quality of life (QoL)
The change of QoL from randomization to the start of radiotherapy,the 16th fraction of radiotherapy, the end of radiotherapy, 43 weeks (at the end of sintilimab treatment in the sintilimab arm and the corresponding timepoint in the chemoradiation arm). The EORTC QoL questionnaire-C30 (EORTC QLQ-C30）version 3.0 will be used. This questionnaire comprises 30 questions, 24 of which are aggregated into nine multi-question scales, that is, five functioning scales (e.g., physical), three symptom scales (e.g., fatigue) and one global health status scale. The remaining six single-question (e.g., dyspnoea) scales assess symptoms. These 15 scales will be scored according to the official Scoring Manual.
Measured: 3 years
Event-free survival (EFS) within different subgroups
analyses for EFS will be performed within the following subgroups: Epstein-Barr virus (EBV) DNA (<4000copies/ml vs. ≥4000copies/ml), EGFR expression status (positive vs negative), different PD-L1 expression levels (<1% vs. ≥1%), tertiary lymphoid structure (+ vs. -), age, gender, performance status, T category, N category, and stage (II vs. III).
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 posted9 Mar 2026
- Study start5 Mar 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2032 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, First Affiliated Hospital of Fujian Medical University, Nanfang Hospital, Southern Medical University, Hunan Provincial Cancer Hospital, Affiliated Hospital of North Sichuan Medical College, First Hospital of China Medical University, Guangdong Provincial People's Hospital, First People's Hospital of Yulin, Wuzhou Red Cross Hospital, LiuZhou People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459296
- Sponsor's protocol ID
- 2026-K0013
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：A Multicenter, Randomized, Controlled, Phase 3 Trial
- ClinicalTrials.gov ID
- NCT07459296
- Acronym / sponsor ID
- 2026-K0013
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- Nasopharyngeal Carcinoma, Becotatug Vedotin, Sintilimab, Concurrent Chemoradiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Collaborators
- Xiangya Hospital of Central South University, First Affiliated Hospital of Fujian Medical University, Nanfang Hospital, Southern Medical University, Hunan Provincial Cancer Hospital, Affiliated Hospital of North Sichuan Medical College, First Hospital of China Medical University, Guangdong Provincial People's Hospital, First People's Hospital of Yulin, Wuzhou Red Cross Hospital, LiuZhou People's Hospital
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2032 (estimated)
- First posted
- 9 Mar 2026 (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 study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), adverse events, and quality of life.
Detailed description
This is a multicenter, randomized, controlled phase III clinical study targeting patients with high-risk locally advanced nasopharyngeal carcinoma (stage T1-4N2-3M0 or T4N1M0 per the 9th AJCC/UICC staging system), with a planned enrollment of 266 patients who will be randomized 1:1 into an experimental group and a control group under an open-label, stratified randomization design. The primary endpoint of the study is 3-year event-free survival (EFS), and the secondary endpoints include efficacy measures such as overall survival and locoregional recurrence-free survival, as well as safety and quality of life assessments; additionally, the study explores the predictive value of efficacy biomarkers including EGFR expression and combined positive score (CPS). The experimental group is administered neoadjuvant therapy with becotatug vedotin plus sintilimab for 3 cycles, followed by concurrent chemoradiotherapy with cisplatin combined with adjuvant sintilimab therapy for 9 cycles, while the control group receives induction chemotherapy with gemcitabine plus cisplatin (GP regimen) for 3 cycles followed by concurrent chemoradiotherapy with cisplatin. Intensity-modulated radiation therapy (IMRT) is uniformly adopted for all patients in both groups, with standardized target volume doses and normal organ dose constraints defined. The study has also formulated detailed protocols for drug dose adjustment and toxicity monitoring; treatment-related adverse events are graded and managed in accordance with the NCI-CTCAE v5.0 and RTOG/EORTC criteria, and the EORTC QLQ-C30 scale is used to evaluate patients' quality of life. The study aims to verify that the innovative treatment regimen of becotatug vedotin combined with sintilimab yields superior efficacy with a manageable safety profile compared with the conventional GP induction chemotherapy followed by chemoradiotherapy in patients with high-risk locally advanced nasopharyngeal carcinoma, thereby providing a novel treatment option for this patient population and supplementing high-level evidence-based medical evidence. Meanwhile, it explores relevant biomarkers to lay a foundation for individualized treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Becotatug Vedotin followed by CCRT plus Sintilimab | Experimental | Drug: Becotatug Vedotin, Drug: Sintilimab, Drug: Cisplatin, Radiation: intensity-modulated radiotherapyPatients will receive Becotatug Vedotin induction therapy followed by CCRT combined with neoadjuvant and adjuvant sintilimab |
| Induction Chemotherapy followed by CCRT | Active comparator | Drug: Cisplatin, Radiation: intensity-modulated radiotherapy, Drug: Gemcitabine (GEM)Patients will receive gemcitabine plus cisplatin induction chemotherapy followed by CCRT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily participate in the study and sign the informed consent form in writing.
- Aged 18-70 years, male or non-pregnant female.
- Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).
- Staged as anyT N2-3 or T4N1 (9th AJCC/UICC staging) without distant metastasis.
- ECOG performance status score of 0-1.
Key exclusion criteria (16 listed)
- Aged > 70 years or < 18 years.
- Patients with recurrent or distant metastatic nasopharyngeal carcinoma.
- Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I).
- Patients who have previously received radiotherapy or systemic chemotherapy.
- Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA > 1000 copies/mL or 200 IU/mL.
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 VedotinBecotatug vedotin 2.3 mg/kg will be given on Day 1 of induction therapy, once every 3 weeks for a total of 3 cycles. | Drug | Becotatug Vedotin followed by CCRT plus Sintilimab |
| SintilimabIn the induction treatment phase, sintilimab 200 mg will be administered on Day 1 of each induction cycle, once every 3 weeks, for a total of 3 cycles. In the adjuvant treatment phase, sintilimab 200 mg will be given on Day 1, initiated 3 weeks after the completion of radiotherapy, once every 3 weeks, for a total of 9 cycles. | Drug | Becotatug Vedotin followed by CCRT plus Sintilimab |
| CisplatinConcurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation | Drug | Becotatug Vedotin followed by CCRT plus Sintilimab, Induction Chemotherapy followed by CCRT |
| intensity-modulated radiotherapyDefinitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions | Radiation | Becotatug Vedotin followed by CCRT plus Sintilimab, Induction Chemotherapy followed by CCRT |
| Gemcitabine (GEM)Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation. | Drug | Induction Chemotherapy followed by CCRT |
| CisplatinInduction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation | Drug | Induction Chemotherapy followed by CCRT |
Primary outcome
Event-free survival (EFS)
Time frame: 3 years
The time interval from randomization to the first treatment failure or the last follow-up if there is no treatment failure. Treatment failure is defined as local/cervical residual disease 16 weeks after radiotherapy, local/cervical recurrence, distant metastasis, or death due to any cause,whichever occurred first.
6 secondary outcomes
Overall survival (OS)
Time frame: 3 years
Distant metastasis-free survival (DMFS)
Time frame: 3 years
Locoregional recurrence-free survival (LRFS)
Time frame: 3 years
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: 3 years
Quality of life (QoL)
Time frame: 3 years
Event-free survival (EFS) within different subgroups
Time frame: 3 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 16 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Becotatug Vedotin, Sintilimab and Cisplatin in people with Nasopharyngeal Carcinoma (NPC), run by First Affiliated Hospital of Guangxi Medical University 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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 16 Mar 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Min Kang, MD (+86-771-5356509, kangmin@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 (EFS) (time frame: 3 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 16 Mar 2026.