Adenoid Cystic CarcinomaPhase 2MRG003-SACCNCT07522879
A Study of Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma
A Phase 2 study testing Becotatug Vedotin in people with Adenoid Cystic Carcinoma and Sinonasal Carcinoma, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This prospective, multicenter clinical study aims to evaluate the efficacy and safety of neoadjuvant therapy with MRG003 (Becotatug vedotin) combined with epirubicin in patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma (SNACC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoid Cystic Carcinoma, Sinonasal Carcinoma
- What is being tested?
- Becotatug Vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2026to 1 Jul 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, male or female. Histopathologically confirmed sinonasal adenoid cystic carcinoma (SNACC) with measurable recurrent disease located in the sinonasal/skull base region, irrespective of the presence of regional lymph node or distant metastases.
- EGFR expression positive by immunohistochemistry (IHC) performed at a central laboratory.
- Multidisciplinary team (MDT) assessment at baseline confirms that the tumor is not amenable to radical (R0) surgical resection.
- At least one measurable lesion in the skull base/sinonasal region according to RECIST v1.1 (longest diameter ≥ 10 mm).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate bone marrow, hepatic, renal, and cardiac function as defined by protocol-specified laboratory parameters.
- Willing to provide written informed consent (including consent for clinical treatment and biospecimen research) and able to comply with study procedures.
Who cannot join
- Prior treatment with any antibody-drug conjugate (ADC) that contains monomethyl auristatin E (MMAE) as the payload.
- Prior systemic chemotherapy containing epirubicin or any other anthracycline within 6 months before study enrollment.
- Active uncontrolled infection, or active autoimmune disease requiring systemic therapy.
- Symptomatic or urgent (e.g., requiring radiotherapy or surgery) central nervous system (CNS) metastases.
- Known severe hypersensitivity to any component of the study drugs. Pregnant or breastfeeding women, or men/women planning to become pregnant within 6 months after the last dose of study treatment.
- Any medical or psychosocial condition that, in the investigator's judgment, may interfere with study participation, increase patient risk, or confound data interpretation.
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
Eye & ENT Hospital of Fudan University
Shanghai
Wanpeng Li, MD, 86-13262856870, 18879117831@163.com
About this study
Official title: Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter Clinical Study
This prospective, multicenter clinical study aims to evaluate the efficacy and safety of neoadjuvant therapy with MRG003 (Becotatug vedotin) combined with epirubicin in patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma (SNACC). The primary question is whether this combination can achieve a sufficient objective response rate (ORR) to enable subsequent radical surgery or improve disease control.
Read the detailed description
This is a prospective, multicenter, single-arm, open-label phase II clinical study. Patients with histologically confirmed recurrent sinonasal adenoid cystic carcinoma (SNACC) that is deemed unresectable by a multidisciplinary team (MDT) and positive for EGFR expression (IHC) are eligible.
Intervention:
- MRG003 (Becotatug vedotin): 2.0 mg/kg IV on day 1 of each 21-day cycle.
- Epirubicin: 75 mg/m² IV on day 1 of each 21-day cycle.
- Total of 3 neoadjuvant cycles.
Primary Outcome Measure: Objective response rate (ORR) according to RECIST v1.1, assessed 21 days (±7 days) after the third cycle.
Secondary Outcome Measures:
- Safety and tolerability (CTCAE v5.0)
- Surgical conversion rate (proportion of patients achieving R0/R1 resection after neoadjuvant therapy)
- R0 resection rate and pathological response rate (major pathological response ≤10% viable tumor cells; pathological complete response 0%)
- Disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)
Sample Size: 40 evaluable patients. Assuming a historical ORR of 10% with single-agent epirubicin, the study is designed to detect an improvement to 35% with the combination (one-sided exact binomial test, α=0.05, power 80%). The sample size also ensures sufficient power for key secondary endpoints and supports the translational sub-study (≥28 successful organoid models).
Translational Research Component: Pre-treatment tumor biopsies will be used to establish patient-derived organoids (PDOs). Organoids will be characterized (H\&E, immunofluorescence, STR genotyping) and tested ex vivo for sensitivity to MRG003, epirubicin, and their combination. Associations between organoid drug sensitivity and clinical response (ORR, tumor shrinkage, PFS) will be explored.
Statistical Analysis: Primary analysis will be performed on the full analysis set (all treated patients). ORR and other binary endpoints will be reported with exact 95% confidence intervals (Clopper-Pearson method). PFS and OS will be estimated using Kaplan-Meier method. Translational data will be analyzed using Spearman rank correlation, Chi-square or Fisher's exact tests, and exploratory Cox regression.
Study Duration: Approximately 48 months, including 24 months enrollment, 3-6 months treatment/short-term follow-up per patient, and 24 months long-term survival follow-up after last patient enrollment.
Data Monitoring: An independent Data Safety Monitoring Board (DSMB) will conduct interim safety review after 20 patients are enrolled.
- Conditions
- Adenoid Cystic Carcinoma, Sinonasal Carcinoma
- Being tested
- Becotatug Vedotin
- Keywords
- EGFR protein, Unresectable, Adenoid cystic carcinoma, Sinonasal, Becotatug vedotin, Epirubicin, Prospective Studies
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug VedotinDrug
Becotatug vedotin (also known as MRG003) is an antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR). It consists of a recombinant anti-EGFR humanized monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a valine-citrulline linker. It is administered intravenously at 2.0 mg/kg on day 1 of each 21-day cycle for 3 cycles.
Epirubicin is an anthracycline chemotherapeutic agent that inhibits topoisomerase II, thereby interfering with DNA replication and transcription. It is administered intravenously at 75 mg/m² on day 1 of each 21-day cycle for 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| MRG003 + Epirubicin | Experimental | Participants receive MRG003 (Becotatug vedotin) 2.0 mg/kg intravenously on day 1 plus epirubicin 75 mg/m² intravenously on day 1 of each 21-day cycle for 3 cycles. Receives: Drug: Becotatug Vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1 criteria.
Measured: 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy (each cycle is 21 days).
Secondary outcomes (7)
Safety and tolerability
Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) graded according to CTCAE v5.0.
Measured: From first dose of study treatment up to 30 days after last dose (approximately 4 months per participant).
Surgical conversion rate
Proportion of participants who undergo radical surgery (R0 or R1 resection) after neoadjuvant therapy, as assessed by multidisciplinary team (MDT).
Measured: Within 4 weeks after completion of neoadjuvant therapy (i.e., approximately 3.5 months from treatment start).
Disease control rate (DCR)
Proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1.
Measured: 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy.
R0 resection rate
Among participants who undergo surgery, proportion with negative microscopic margins (R0) on final histopathology.
Measured: At time of surgery (within 4 weeks after neoadjuvant therapy completion).
Pathologic response rate
Among participants who undergo surgery, proportion achieving major pathologic response (≤10% viable tumor cells) or pathologic complete response (0% viable tumor cells).
Measured: At time of surgery (within 4 weeks after neoadjuvant therapy completion).
Progression-free survival (PFS)
Time from enrollment to first documented disease progression (by RECIST v1.1) or death from any cause, whichever occurs first.
Measured: Assessed every 3 months for the first 2 years, then every 6 months up to 5 years, or until death or study completion (up to 48 months from first participant enrolled).
Overall survival (OS)
Time from enrollment to death from any cause.
Measured: Assessed every 3 months for the first 2 years, then every 6 months up to 5 years, or until death or study completion (up to 48 months from first participant enrolled).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start28 Apr 2026
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adenoid Cystic CarcinomaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Liu, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522879
- Sponsor's protocol ID
- FudanENT-2026041-1
- Acronym
- MRG003-SACC
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agulnik M, Cohen EW, Cohen RB, Chen EX, Vokes EE, Hotte SJ, Winquist E, Laurie S, Hayes DN, Dancey JE, Brown S, Pond GR, Lorimer I, Daneshmand M, Ho J, Tsao MS, Siu LL. Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. J Clin Oncol. 2007 Sep 1;25(25):3978-84. doi: 10.1200/JCO.2007.11.8612.
PubMed 17761983Vered M, Braunstein E, Buchner A. Immunohistochemical study of epidermal growth factor receptor in adenoid cystic carcinoma of salivary gland origin. Head Neck. 2002 Jul;24(7):632-6. doi: 10.1002/hed.10104.
PubMed 12112535Zhou J, Zhao G, Wang S, Li N. Systemic therapy in the management of metastatic or locally recurrent adenoid cystic carcinoma of the salivary glands: a systematic review of the last decade. Br J Cancer. 2024 Oct;131(6):1021-1031. doi: 10.1038/s41416-024-02795-4. Epub 2024 Aug 3.
PubMed 39097677Lupinetti AD, Roberts DB, Williams MD, Kupferman ME, Rosenthal DI, Demonte F, El-Naggar A, Weber RS, Hanna EY. Sinonasal adenoid cystic carcinoma: the M. D. Anderson Cancer Center experience. Cancer. 2007 Dec 15;110(12):2726-31. doi: 10.1002/cncr.23096.
PubMed 17960615Mavrikios A, Goudjil F, Beddok A, Zefkili S, Bolle S, Feuvret L, Le Tourneau C, Choussy O, Sauvaget E, Herman P, Dendale R, Calugaru V. Proton therapy and/or helical tomotherapy for locally advanced sinonasal skull base adenoid cystic carcinoma: Focus on experience of the Institut Curie and review of literature. Head Neck. 2023 Jul;45(7):1619-1631. doi: 10.1002/hed.27371. Epub 2023 Apr 25.
PubMed 37097003
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Becotatug Vedotin (MRG003) Combined With Epirubicin as Neoadjuvant Therapy for EGFR-Positive, Unresectable Recurrent Sinonasal Adenoid Cystic Carcinoma: A Prospective, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT07522879
- Acronym / sponsor ID
- MRG003-SACC / FudanENT-2026041-1
- Conditions
- Adenoid Cystic Carcinoma, Sinonasal Carcinoma
- Keywords
- EGFR protein, Unresectable, Adenoid cystic carcinoma, Sinonasal, Becotatug vedotin, Epirubicin, Prospective Studies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 13 Apr 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 prospective, multicenter clinical study aims to evaluate the efficacy and safety of neoadjuvant therapy with MRG003 (Becotatug vedotin) combined with epirubicin in patients with EGFR-positive, unresectable recurrent sinonasal adenoid cystic carcinoma (SNACC). The primary question is whether this combination can achieve a sufficient objective response rate (ORR) to enable subsequent radical surgery or improve disease control.
Detailed description
This is a prospective, multicenter, single-arm, open-label phase II clinical study. Patients with histologically confirmed recurrent sinonasal adenoid cystic carcinoma (SNACC) that is deemed unresectable by a multidisciplinary team (MDT) and positive for EGFR expression (IHC) are eligible.
Intervention:
- MRG003 (Becotatug vedotin): 2.0 mg/kg IV on day 1 of each 21-day cycle.
- Epirubicin: 75 mg/m² IV on day 1 of each 21-day cycle.
- Total of 3 neoadjuvant cycles.
Primary Outcome Measure: Objective response rate (ORR) according to RECIST v1.1, assessed 21 days (±7 days) after the third cycle.
Secondary Outcome Measures:
- Safety and tolerability (CTCAE v5.0)
- Surgical conversion rate (proportion of patients achieving R0/R1 resection after neoadjuvant therapy)
- R0 resection rate and pathological response rate (major pathological response ≤10% viable tumor cells; pathological complete response 0%)
- Disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)
Sample Size: 40 evaluable patients. Assuming a historical ORR of 10% with single-agent epirubicin, the study is designed to detect an improvement to 35% with the combination (one-sided exact binomial test, α=0.05, power 80%). The sample size also ensures sufficient power for key secondary endpoints and supports the translational sub-study (≥28 successful organoid models).
Translational Research Component: Pre-treatment tumor biopsies will be used to establish patient-derived organoids (PDOs). Organoids will be characterized (H\&E, immunofluorescence, STR genotyping) and tested ex vivo for sensitivity to MRG003, epirubicin, and their combination. Associations between organoid drug sensitivity and clinical response (ORR, tumor shrinkage, PFS) will be explored.
Statistical Analysis: Primary analysis will be performed on the full analysis set (all treated patients). ORR and other binary endpoints will be reported with exact 95% confidence intervals (Clopper-Pearson method). PFS and OS will be estimated using Kaplan-Meier method. Translational data will be analyzed using Spearman rank correlation, Chi-square or Fisher's exact tests, and exploratory Cox regression.
Study Duration: Approximately 48 months, including 24 months enrollment, 3-6 months treatment/short-term follow-up per patient, and 24 months long-term survival follow-up after last patient enrollment.
Data Monitoring: An independent Data Safety Monitoring Board (DSMB) will conduct interim safety review after 20 patients are enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRG003 + Epirubicin | Experimental | Drug: Becotatug VedotinParticipants receive MRG003 (Becotatug vedotin) 2.0 mg/kg intravenously on day 1 plus epirubicin 75 mg/m² intravenously on day 1 of each 21-day cycle for 3 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years, male or female. Histopathologically confirmed sinonasal adenoid cystic carcinoma (SNACC) with measurable recurrent disease located in the sinonasal/skull base region, irrespective of the presence of regional lymph node or distant metastases.
- EGFR expression positive by immunohistochemistry (IHC) performed at a central laboratory.
- Multidisciplinary team (MDT) assessment at baseline confirms that the tumor is not amenable to radical (R0) surgical resection.
- At least one measurable lesion in the skull base/sinonasal region according to RECIST v1.1 (longest diameter ≥ 10 mm).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Adequate bone marrow, hepatic, renal, and cardiac function as defined by protocol-specified laboratory parameters.
Key exclusion criteria (6 listed)
- Prior treatment with any antibody-drug conjugate (ADC) that contains monomethyl auristatin E (MMAE) as the payload.
- Prior systemic chemotherapy containing epirubicin or any other anthracycline within 6 months before study enrollment.
- Active uncontrolled infection, or active autoimmune disease requiring systemic therapy.
- Symptomatic or urgent (e.g., requiring radiotherapy or surgery) central nervous system (CNS) metastases.
- Known severe hypersensitivity to any component of the study drugs. Pregnant or breastfeeding women, or men/women planning to become pregnant within 6 months after the last dose of study treatment.
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 (also known as MRG003) is an antibody-drug conjugate (ADC) targeting epidermal growth factor receptor (EGFR). It consists of a recombinant anti-EGFR humanized monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a valine-citrulline linker. It is administered intravenously at 2.0 mg/kg on day 1 of each 21-day cycle for 3 cycles. Epirubicin is an anthracycline chemotherapeutic agent that inhibits topoisomerase II, thereby interfering with DNA replication and transcription. It is administered intravenously at 75 mg/m² on day 1 of each 21-day cycle for 3 cycles. | Drug | MRG003 + Epirubicin |
Primary outcome
Objective Response Rate (ORR)
Time frame: 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy (each cycle is 21 days).
Proportion of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1 criteria.
7 secondary outcomes
Safety and tolerability
Time frame: From first dose of study treatment up to 30 days after last dose (approximately 4 months per participant).
Surgical conversion rate
Time frame: Within 4 weeks after completion of neoadjuvant therapy (i.e., approximately 3.5 months from treatment start).
Disease control rate (DCR)
Time frame: 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy.
R0 resection rate
Time frame: At time of surgery (within 4 weeks after neoadjuvant therapy completion).
Pathologic response rate
Time frame: At time of surgery (within 4 weeks after neoadjuvant therapy completion).
Progression-free survival (PFS)
Time frame: Assessed every 3 months for the first 2 years, then every 6 months up to 5 years, or until death or study completion (up to 48 months from first participant enrolled).
Overall survival (OS)
Time frame: Assessed every 3 months for the first 2 years, then every 6 months up to 5 years, or until death or study completion (up to 48 months from first participant enrolled).
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 28 Jul 2026.
- Results publication: PubMed 17761983Agulnik M, Cohen EW, Cohen RB, Chen EX, Vokes EE, Hotte SJ, Winquist E, Laurie S, Hayes DN, Dancey JE, Brown S, Pond GR, Lorimer I, Daneshmand M, Ho J, Tsao MS, Siu LL. Phase II study of lapatinib in recurrent or metastatic epidermal growth factor receptor and/or erbB2 expressing adenoid cystic carcinoma and non adenoid cystic carcinoma malignant tumors of the salivary glands. J Clin Oncol. 2007 Sep 1;25(25):3978-84. doi: 10.1200/JCO.2007.11.8612.
- Results publication: PubMed 12112535Vered M, Braunstein E, Buchner A. Immunohistochemical study of epidermal growth factor receptor in adenoid cystic carcinoma of salivary gland origin. Head Neck. 2002 Jul;24(7):632-6. doi: 10.1002/hed.10104.
- Results publication: PubMed 39097677Zhou J, Zhao G, Wang S, Li N. Systemic therapy in the management of metastatic or locally recurrent adenoid cystic carcinoma of the salivary glands: a systematic review of the last decade. Br J Cancer. 2024 Oct;131(6):1021-1031. doi: 10.1038/s41416-024-02795-4. Epub 2024 Aug 3.
- Results publication: PubMed 17960615Lupinetti AD, Roberts DB, Williams MD, Kupferman ME, Rosenthal DI, Demonte F, El-Naggar A, Weber RS, Hanna EY. Sinonasal adenoid cystic carcinoma: the M. D. Anderson Cancer Center experience. Cancer. 2007 Dec 15;110(12):2726-31. doi: 10.1002/cncr.23096.
- Results publication: PubMed 37097003Mavrikios A, Goudjil F, Beddok A, Zefkili S, Bolle S, Feuvret L, Le Tourneau C, Choussy O, Sauvaget E, Herman P, Dendale R, Calugaru V. Proton therapy and/or helical tomotherapy for locally advanced sinonasal skull base adenoid cystic carcinoma: Focus on experience of the Institut Curie and review of literature. Head Neck. 2023 Jul;45(7):1619-1631. doi: 10.1002/hed.27371. Epub 2023 Apr 25.
- Individual participant dataSharing planned: No
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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 Adenoid Cystic Carcinoma and Sinonasal Carcinoma, run by Eye & ENT Hospital of Fudan 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 6 inclusion and 6 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 28 Jul 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 Quan Liu, Director (8615001959681, liuqent@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 21 days (±7 days) after completion of the third cycle of neoadjuvant therapy (each cycle is 21 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07522879, which also lists 5 linked publications.
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 28 Jul 2026.