Head and Neck Squamous Cell Carcinoma, HNSCCPhase 2NCT07814287
Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing Becotatug Vedotin, Pucotenlimab, and Cisplatin in people with Head and Neck Squamous Cell Carcinoma, HNSCC, run by Xuekui Liu at 2 sites in China.
Trial summary
This prospective, single-arm, multicenter phase II trial aims to evaluate the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, HNSCC
- What is being tested?
- Becotatug Vedotin, Pucotenlimab, and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesChina
- Study dates
- 15 Apr 2026to 31 Dec 2028
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed, previously untreated (excluding diagnostic procedures) head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx) with EGFR protein expression confirmed by immunohistochemistry (IHC), and has not received targeted therapy against the EGFR signaling pathway within 6 months prior to enrollment.
- Clinical stage T2N2-3M0 or T3-4N0-3M0 (stage III-IV) per AJCC 8th edition.
- Age 18 to 70 years.
- ECOG performance status 0 or 1.
- Assessed by head and neck oncologist as locally advanced without distant metastasis.
- At least one measurable lesion per RECIST v1.1.
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- Toxicity assessment per CTCAE v4.03 (for baseline evaluation).
- Adequate organ function to tolerate surgery:
- Hematologic: WBC ≥4,000/μL, ANC ≥2,000/μL, hemoglobin ≥9 g/dL, platelets ≥100,000/μL.
- Hepatic: bilirubin ≤1.5×ULN (or ≤3×ULN if known Gilbert's syndrome), AST and ALT ≤3×ULN, alkaline phosphatase ≤3×ULN, albumin ≥3 g/dL.
- Renal: serum creatinine ≤1.5×ULN or calculated creatinine clearance ≥60 mL/min (Cockcroft-Gault).
- Willing to provide archived tumor tissue or undergo biopsy to submit at least 3 unstained FFPE sections (additional if needed) for central PD-L1 IHC testing; lesion used for biopsy cannot be a target lesion unless no other suitable lesion exists.
- Signed informed consent and willingness to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- History of severe hypersensitivity to any component of other monoclonal antibodies, CTLA-4, or PD-1/PD-L1 inhibitors.
- Known or suspected autoimmune disease, including dementia and seizure disorder.
- Recurrent or metastatic disease, concurrent other malignancy, or judged inoperable by head and neck surgeon.
- Coagulation abnormalities (PT >16 s, APTT >53 s, TT >21 s, Fib <1.5 g/L), bleeding tendency, or current thrombolytic/anticoagulant therapy.
- Severe cardiac or pulmonary dysfunction less than grade 3 (including grade 3).
- Laboratory values not meeting eligibility criteria within 7 days prior to enrollment.
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- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other agents targeting T-cell co-stimulation or checkpoint pathways).
- Comorbid conditions requiring chronic immunosuppressive therapy or systemic/local corticosteroids at immunosuppressive doses.
- Positive HIV; HBsAg-positive with detectable HBV DNA (≥1000 copies/mL); positive HCV antibody with detectable HCV RNA (if tested).
- Use of traditional herbal medicines with antitumor indications within 4 weeks prior to randomization.
- Active or history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea).
- Positive pregnancy test (for women of childbearing potential) or breastfeeding.
- Known active tuberculosis (TB); suspected cases require clinical evaluation to rule out.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Severe infection within 4 weeks prior to first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia.
- Planned major surgery within 30 days after first dose (or not fully recovered from prior surgery), except for minor procedures (e.g., port placement, biopsy) if performed at least 24 hours before first dose.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhongyu Wang, MD, +86 15968705158, liql@sysucc.org.cn
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
xuekui liu, doctor, (86-20) 8734 3768, liuxk@sysucc.org.cn
About this study
Official title: Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma: A Phase II Prospective Single-Arm Multicenter Trial
This prospective, single-arm, multicenter phase II trial aims to evaluate the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). A total of 40 treatment-naive patients aged 18-70 years with stage III-IV (AJCC 8th edition) EGFR-positive HNSCC will be enrolled. Participants will receive three 3-week cycles of the triple-drug regimen. Tumor response will be reassessed after cycle 3 using RECIST v1.1. Patients achieving a complete or partial response (CR/PR) may proceed to de-escalation surgery followed by definitive chemoradiotherapy, or to definitive chemoradiotherapy alone; non-responders will undergo radical surgery with or without radiotherapy/chemoradiotherapy, or definitive chemoradiotherapy, as determined by multidisciplinary team (MDT) discussion. The primary endpoint is objective response rate (ORR). Secondary endpoints include major pathological response (MPR), pathological complete response (pCR), disease control rate (DCR), 2-year progression-free survival (PFS), 2-year overall survival (OS), quality of life, and safety.
This study aims to provide preliminary evidence on the feasibility and activity of this novel triple combination in the neoadjuvant setting, potentially offering a new treatment paradigm to improve long-term outcomes and reduce recurrence.
Read the detailed description
This is a prospective, single-arm, multicenter phase II trial evaluating the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). A total of 40 treatment-naïve patients aged 18-70 years with stage III-IV (AJCC 8th edition) EGFR-positive (IHC) HNSCC will be enrolled. Participants receive 3 cycles (every 3 weeks) of beccotatug vedotin, pucotenlimab, and cisplatin. After 3 cycles, tumor response is reassessed by RECIST v1.1. Responders (CR/PR) may proceed to de-escalation surgery plus definitive chemoradiotherapy or definitive chemoradiotherapy alone, while non-responders undergo radical surgery ± radiotherapy/chemoradiotherapy or definitive chemoradiotherapy as per multidisciplinary team (MDT) discussion. The primary endpoint is objective response rate (ORR). Secondary endpoints include major pathological response (MPR), pathological complete response (pCR), disease control rate (DCR), 2-year progression-free survival (PFS), 2-year overall survival (OS), quality of life (EORTC QLQ-C30 and QLQ-H\&N35), and safety (NCI-CTCAE v5.0).
This study aims to provide preliminary evidence on the feasibility and activity of this novel triple combination in the neoadjuvant setting, potentially offering a new treatment paradigm to improve long-term outcomes and reduce recurrence.
- Being tested
- Becotatug Vedotin, Pucotenlimab, and Cisplatin
- Keywords
- antibody-drug conjugate, Head and neck squamous cell carcinoma, HNSCC, Neoadjuvant combination therapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Becotatug Vedotin, Pucotenlimab, and CisplatinDrug
Becotatug vedotin is an EGFR-directed antibody-drug conjugate (ADC) comprising a humanized anti-EGFR monoclonal antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable valine-citrulline linker. It binds to EGFR-overexpressing tumor cells, undergoes receptor-mediated internalization, and releases MMAE to inhibit microtubule polymerization, inducing cell cycle arrest and apoptosis. Pucotenlimab is a humanized anti-PD-1 monoclonal antibody that blocks the PD-1/PD-L1 interaction, restoring T-cell-mediated antitumor immune responses. Cisplatin is a platinum-based alkylating agent that forms DNA crosslinks, leading to cell death. These three agents are administered as sequential intravenous infusions on Day 1 of each 21-day cycle: pucotenlimab 200 mg, followed by beccotatug vedotin 2.0 mg/kg, and cisplatin 60 mg/m². The regimen is given for up to 3 neoadjuvant cycles prior to definitive local therapy.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Beccotatug Vedotin + Pucotenlimab + Cisplatin for Locally Advanced EGFR-positive HNSCC | Experimental | Participants receive 3 cycles of neoadjuvant combination therapy on a 21-day (Q3W) cycle. On Day 1 of each cycle, pucotenlimab 200 mg is administered intravenously over 60 ± 15 minutes, followed at least 30 minutes later by beccotatug vedotin 2.0 mg/kg intravenously over 60 ± 10 minutes, and cisplatin 60 mg/m² intravenously on the same day. All drugs are given at full doses (permissible ±10% variance) with protocol-defined dose modifications for toxicity per NCI-CTCAE v5.0. After completing 3 cycles, tumor response is reassessed per RECIST v1.1. Responders (CR/PR) may proceed to de-escalation surgery plus definitive chemoradiotherapy or definitive chemoradiotherapy alone, while non-responders undergo radical surgery with or without radiotherapy/chemoradiotherapy or definitive chemoradiotherapy alone based on multidisciplinary team evaluation. Beccotatug vedotin and pucotenlimab are not administered during the subsequent concurrent chemoradiotherapy phase. Receives: Drug: Becotatug Vedotin, Pucotenlimab, and Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Objective response rate defined as the proportion of patients achieving a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 after neoadjuvant therapy.
Measured: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
Secondary outcomes (8)
Major Pathological Response (MPR)
MPR is defined as the presence of ≤10% viable residual tumour cells in the surgical specimen after neoadjuvant therapy.
Measured: At the completion of definitive surgery
Pathological Complete Response (pCR)
pCR means the complete absence of invasive tumour cells in the resected primary tumour and all sampled regional lymph nodes (ypT0ypN0).
Measured: At the completion of definitive surgery
Disease Control Rate (DCR)
DCR is the proportion of patients who achieve a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST v1.1, maintained for a specified duration.
Measured: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
2-Year Progression-Free Survival (PFS)
PFS is the time from treatment initiation (or randomisation) until the first occurrence of disease progression (per RECIST v1.1) or death from any cause.
Measured: Up to 2 years
2-Year Overall Survival (OS)
Definition: OS is the time from treatment initiation to death from any cause.
Measured: Up to 2 years
Health-Related Quality of Life assessed by the EORTC QLQ-C30
Quality of life and functional status are assessed using the validated EORTC QLQ-C30 (version 3.0). All scores are linearly transformed to a 0-100 scale; higher scores indicate better global health status and functioning, but worse symptom burden. Administered per the standard EORTC scoring manual.
Measured: 2 years
EORTC QLQ-H&N35 Module
Head and neck cancer-specific quality of life is assessed using the validated EORTC QLQ-H\&N35 module. All item scores are linearly transformed to a 0-100 scale. For this module, higher scores indicate worse symptom burden and poorer quality of life. The questionnaire is administered per the standard EORTC manual.
Measured: 2 years
Safety Endpoints (Safety Profiles)
This includes the incidence, severity, and attribution of adverse events (AEs), serious adverse events (SAEs), treatment-related AEs, dose modifications, delays, and discontinuations.
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 posted10 Sep 2026
- Study start15 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma, HNSCCStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuekui Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuekui Liu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814287
- Sponsor's protocol ID
- SL-B2026-102-02
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Becotatug Vedotin Plus Pucotenlimab and Platinum Chemotherapy in Locally Advanced Epidermal Growth Factor Receptor (EGFR)-Positive Head and Neck Squamous Cell Carcinoma: A Phase II Prospective Single-Arm Multicenter Trial
- ClinicalTrials.gov ID
- NCT07814287
- Acronym / sponsor ID
- SL-B2026-102-02
- Keywords
- antibody-drug conjugate, Head and neck squamous cell carcinoma, HNSCC, Neoadjuvant combination therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuekui LiuUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Sep 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, single-arm, multicenter phase II trial aims to evaluate the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). A total of 40 treatment-naive patients aged 18-70 years with stage III-IV (AJCC 8th edition) EGFR-positive HNSCC will be enrolled. Participants will receive three 3-week cycles of the triple-drug regimen. Tumor response will be reassessed after cycle 3 using RECIST v1.1. Patients achieving a complete or partial response (CR/PR) may proceed to de-escalation surgery followed by definitive chemoradiotherapy, or to definitive chemoradiotherapy alone; non-responders will undergo radical surgery with or without radiotherapy/chemoradiotherapy, or definitive chemoradiotherapy, as determined by multidisciplinary team (MDT) discussion. The primary endpoint is objective response rate (ORR). Secondary endpoints include major pathological response (MPR), pathological complete response (pCR), disease control rate (DCR), 2-year progression-free survival (PFS), 2-year overall survival (OS), quality of life, and safety.
This study aims to provide preliminary evidence on the feasibility and activity of this novel triple combination in the neoadjuvant setting, potentially offering a new treatment paradigm to improve long-term outcomes and reduce recurrence.
Detailed description
This is a prospective, single-arm, multicenter phase II trial evaluating the efficacy and safety of neoadjuvant beccotatug vedotin combined with pucotenlimab and cisplatin in patients with locally advanced epidermal growth factor receptor (EGFR)-positive head and neck squamous cell carcinoma (HNSCC). A total of 40 treatment-naïve patients aged 18-70 years with stage III-IV (AJCC 8th edition) EGFR-positive (IHC) HNSCC will be enrolled. Participants receive 3 cycles (every 3 weeks) of beccotatug vedotin, pucotenlimab, and cisplatin. After 3 cycles, tumor response is reassessed by RECIST v1.1. Responders (CR/PR) may proceed to de-escalation surgery plus definitive chemoradiotherapy or definitive chemoradiotherapy alone, while non-responders undergo radical surgery ± radiotherapy/chemoradiotherapy or definitive chemoradiotherapy as per multidisciplinary team (MDT) discussion. The primary endpoint is objective response rate (ORR). Secondary endpoints include major pathological response (MPR), pathological complete response (pCR), disease control rate (DCR), 2-year progression-free survival (PFS), 2-year overall survival (OS), quality of life (EORTC QLQ-C30 and QLQ-H\&N35), and safety (NCI-CTCAE v5.0).
This study aims to provide preliminary evidence on the feasibility and activity of this novel triple combination in the neoadjuvant setting, potentially offering a new treatment paradigm to improve long-term outcomes and reduce recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Beccotatug Vedotin + Pucotenlimab + Cisplatin for Locally Advanced EGFR-positive HNSCC | Experimental | Drug: Becotatug Vedotin, Pucotenlimab, and CisplatinParticipants receive 3 cycles of neoadjuvant combination therapy on a 21-day (Q3W) cycle. On Day 1 of each cycle, pucotenlimab 200 mg is administered intravenously over 60 ± 15 minutes, followed at least 30 minutes later by beccotatug vedotin 2.0 mg/kg intravenously over 60 ± 10 minutes, and cisplatin 60 mg/m² intravenously on the same day. All drugs are given at full doses (permissible ±10% variance) with protocol-defined dose modifications for toxicity per NCI-CTCAE v5.0. After completing 3 cycles, tumor response is reassessed per RECIST v1.1. Responders (CR/PR) may proceed to de-escalation surgery plus definitive chemoradiotherapy or definitive chemoradiotherapy alone, while non-responders undergo radical surgery with or without radiotherapy/chemoradiotherapy or definitive chemoradiotherapy alone based on multidisciplinary team evaluation. Beccotatug vedotin and pucotenlimab are not administered during the subsequent concurrent chemoradiotherapy phase. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically and/or cytologically confirmed, previously untreated (excluding diagnostic procedures) head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx) with EGFR protein expression confirmed by immunohistochemistry (IHC), and has not received targeted therapy against the EGFR signaling pathway within 6 months prior to enrollment.
- Clinical stage T2N2-3M0 or T3-4N0-3M0 (stage III-IV) per AJCC 8th edition.
- Age 18 to 70 years.
- ECOG performance status 0 or 1.
- Assessed by head and neck oncologist as locally advanced without distant metastasis.
Key exclusion criteria (16 listed)
- History of severe hypersensitivity to any component of other monoclonal antibodies, CTLA-4, or PD-1/PD-L1 inhibitors.
- Known or suspected autoimmune disease, including dementia and seizure disorder.
- Recurrent or metastatic disease, concurrent other malignancy, or judged inoperable by head and neck surgeon.
- Coagulation abnormalities (PT >16 s, APTT >53 s, TT >21 s, Fib <1.5 g/L), bleeding tendency, or current thrombolytic/anticoagulant therapy.
- Severe cardiac or pulmonary dysfunction less than grade 3 (including grade 3).
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 Vedotin, Pucotenlimab, and CisplatinBecotatug vedotin is an EGFR-directed antibody-drug conjugate (ADC) comprising a humanized anti-EGFR monoclonal antibody conjugated to monomethyl auristatin E (MMAE) via a cleavable valine-citrulline linker. It binds to EGFR-overexpressing tumor cells, undergoes receptor-mediated internalization, and releases MMAE to inhibit microtubule polymerization, inducing cell cycle arrest and apoptosis. Pucotenlimab is a humanized anti-PD-1 monoclonal antibody that blocks the PD-1/PD-L1 interaction, restoring T-cell-mediated antitumor immune responses. Cisplatin is a platinum-based alkylating agent that forms DNA crosslinks, leading to cell death. These three agents are administered as sequential intravenous infusions on Day 1 of each 21-day cycle: pucotenlimab 200 mg, followed by beccotatug vedotin 2.0 mg/kg, and cisplatin 60 mg/m². The regimen is given for up to 3 neoadjuvant cycles prior to definitive local therapy. | Drug | Neoadjuvant Beccotatug Vedotin + Pucotenlimab + Cisplatin for Locally Advanced EGFR-positive HNSCC |
Primary outcome
Objective response rate
Time frame: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
Objective response rate defined as the proportion of patients achieving a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 after neoadjuvant therapy.
8 secondary outcomes
Major Pathological Response (MPR)
Time frame: At the completion of definitive surgery
Pathological Complete Response (pCR)
Time frame: At the completion of definitive surgery
Disease Control Rate (DCR)
Time frame: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)
2-Year Progression-Free Survival (PFS)
Time frame: Up to 2 years
2-Year Overall Survival (OS)
Time frame: Up to 2 years
Health-Related Quality of Life assessed by the EORTC QLQ-C30
Time frame: 2 years
EORTC QLQ-H&N35 Module
Time frame: 2 years
Safety Endpoints (Safety Profiles)
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 10 Sep 2026.
- 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.
2 sites 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, Pucotenlimab, and Cisplatin in people with Head and Neck Squamous Cell Carcinoma, HNSCC, run by Xuekui Liu at 2 sites 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 13 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Zhongyu Wang, MD (+86 15968705158, wangzy2@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: After 3 cycles of neoadjuvant therapy (approximately 9 weeks)). 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 10 Sep 2026.