Head and Neck Squamous Cell CarcinomaPhase 2NCT07677475
MRG003 Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 2 study testing MRG003 (Becotatug vedotin) and Toripalimab and Toripalimab in people with Head and Neck Squamous Cell Carcinoma, run by Dongguan People's Hospital at 1 site in China.
Trial summary
This is a multicenter, prospective, randomized, controlled Phase II trial evaluating the safety and efficacy of MRG003 (Becotatug vedotin) combined with Toripalimab versus Toripalimab alone as neoadjuvant therapy for PD-L1-positive, resectable locally advanced head and neck squamous cell carcinoma. 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
- What is being tested?
- MRG003 (Becotatug vedotin) and Toripalimab and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2026to 30 Jun 2029
- 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
- Histologically or cytologically confirmed head and neck squamous cell carcinoma (HNSCC), PD-L1 positive (CPS ≥ 1)
- Treatment-naïve, pathologically confirmed stage III-IVA resectable non-oropharyngeal HNSCC (oral cavity, larynx, hypopharynx) OR HPV-negative oropharyngeal SCC, OR HPV-positive stage III T4N0-2 resectable oropharyngeal cancer (AJCC 8th edition)
- No prior antitumor treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy)
- Age 18 to 70 years
- ECOG performance status 0 or 1
- Adequate organ function within 14 days before first dose (no blood products or growth factors within 14 days):
- ANC ≥ 1.0 × 10⁹/L, Hb ≥ 90 g/L, PLT ≥ 75 × 10⁹/L
- ALT/AST ≤ 1.5 × ULN, total bilirubin ≤ 1.5 × ULN, ALP < 2.5 × ULN
- CrCl ≥ 50 mL/min (Cockcroft-Gault)
- APTT and INR ≤ 1.5 × ULN
- At least one measurable lesion per RECIST 1.1
- Life expectancy ≥ 12 weeks
- Female subjects of childbearing potential and male subjects with reproductive potential must use medically accepted contraception during treatment and for 3 months after last dose
- Voluntary signed informed consent, good compliance, willing to undergo follow-up
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 Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital)
Dongguan, Guangdong, 523059
Liji Jiang, Master, 0769-28637916, keynotejiang@163.com
About this study
Official title: MRG003 (Becotatug Vedotin) Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Prospective, Randomized, Controlled Phase II Trial
This is a multicenter, prospective, randomized, controlled Phase II trial evaluating the safety and efficacy of MRG003 (Becotatug vedotin) combined with Toripalimab versus Toripalimab alone as neoadjuvant therapy for PD-L1-positive, resectable locally advanced head and neck squamous cell carcinoma. A total of 65 subjects are planned (43 experimental, 22 control). The experimental arm receives two cycles of MRG003 (Becotatug vedotin) 2.0 mg/kg intravenously on Day 1 followed by Toripalimab 240 mg intravenously on Day 1 every 3 weeks, while the control arm receives two cycles of Toripalimab 240 mg alone. After neoadjuvant therapy, both arms undergo radical surgery 3-4 weeks later, followed by risk-adapted adjuvant radiotherapy or chemoradiotherapy with concurrent Toripalimab (3 cycles) and then 12 cycles of adjuvant Toripalimab maintenance. The primary endpoint is the major pathological response rate.
Read the detailed description
This study builds upon the limitations of neoadjuvant immunotherapy monotherapy (e.g., KEYNOTE-689), which showed a low MPR rate (9.8% overall, 13.7% in CPS>10) and a 25.6% progression rate, by exploring the synergistic combination of the EGFR-targeting antibody-drug conjugate MRG (Becotatug vedotin) with the PD-1 inhibitor Toripalimab. Eligible patients are treatment-naïve, PD-L1 positive (CPS ≥1), stage III-IVA resectable non-oropharyngeal, HPV-negative oropharyngeal, or specific HPV-positive oropharyngeal HNSCC, ECOG PS 0-1, aged 18-70. In the neoadjuvant phase, the experimental group receives MRG (Becotatug vedotin) 2.0 mg/kg (based on actual body weight) intravenously without prophylactic premedication, followed by Toripalimab 240 mg intravenously over 30-60 minutes on Day 1 of each 3-week cycle for 2 cycles; infusion reactions are monitored for at least 120 minutes after the first dose and 60 minutes thereafter. Dose reduction of MRG (Becotatug vedotin) to 1.5 mg/kg is permitted for toxicity, with permanent discontinuation if intolerance persists; Toripalimab dose modification is not allowed. The control group receives Toripalimab 240 mg alone on the same schedule. Three to four weeks after Cycle 2 Day 1, both arms undergo radical tumor resection; surgery is performed even if radiological progression occurs during neoadjuvant therapy, provided surgical criteria are met. Postoperatively, patients are stratified by pathology: those with extranodal extension or positive/inadequate margins receive adjuvant chemoradiotherapy (cisplatin 100 mg/m² every 3 weeks for 3 cycles plus radiotherapy at 60-70 Gy depending on risk), while those without receive adjuvant radiotherapy alone (same doses). During adjuvant radiotherapy, both arms concurrently receive 3 cycles of Toripalimab 240 mg every 3 weeks. After completing radiotherapy, all patients receive 12 cycles of adjuvant Toripalimab 240 mg every 3 weeks as maintenance. Secondary endpoints include event-free survival, pathologic complete response rate, objective response rate, R0 resection rate, surgical down-staging rate, safety (CTCAE v6.0), and quality of life; exploratory endpoints include overall survival and biomarker analysis. The MPR rate is compared using the exact test, assuming 45% in the experimental arm versus approximately 9.8% in the historical control, with a one-sided alpha of 0.025, 80% power, and 10% dropout, yielding the required sample size of 65. The full analysis set is the primary analysis population.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- MRG003 (Becotatug vedotin) and Toripalimab, Toripalimab
- Keywords
- MRG003, Vebecototagene Autoleucovorin, Toripalimab, Neoadjuvant 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.
MRG003 (Becotatug vedotin) and ToripalimabDrug
Toripalimab 240 mg administered intravenously over 30-60 minutes on Day 1 of each 3-week cycle, followed immediately by MRG003 (Becotatug vedotin) 2.0 mg/kg (based on actual body weight) administered intravenously without prophylactic premedication. Neoadjuvant phase: 2 cycles of both drugs. Adjuvant toripalimab: 3 cycles concurrent with radiotherapy, then 12 cycles maintenance. For MRG003 (Becotatug vedotin), monitor infusion reactions for at least 120 minutes after first dose and at least 60 minutes after subsequent doses if tolerated. Dose reduction of MRG003 (Becotatug vedotin) to 1.5 mg/kg is permitted once for toxicity; permanent discontinuation if intolerance persists at reduced dose. Toripalimab dose remains fixed throughout; no dose modification is permitted.
ToripalimabDrug
Toripalimab 240 mg administered intravenously over 30-60 minutes on Day 1 of each 3-week cycle. Neoadjuvant phase: 2 cycles. Adjuvant phase (concurrent with radiotherapy): 3 cycles. Adjuvant maintenance (after radiotherapy): 12 cycles. No prophylactic premedication required. No dose modification of toripalimab is permitted.
| Study group | Role | What they receive |
|---|---|---|
| MRG003 + Toripalimab | Experimental | Participants receive 2 cycles of neoadjuvant combination therapy with toripalimab plus MRG003 (Becotatug vedotin). After the neoadjuvant phase, radical surgery is performed. Postoperative management follows the same risk-adapted criteria as the control arm: participants with ENE or positive/inadequate margins receive adjuvant chemoradiotherapy, while those without receive adjuvant radiotherapy alone. During adjuvant radiotherapy, participants receive 3 cycles of concurrent toripalimab. After radiotherapy, all participants receive 12 cycles of adjuvant toripalimab maintenance therapy. Receives: Drug: MRG003 (Becotatug vedotin) and Toripalimab; Drug: Toripalimab |
| Toripalimab Monotherapy | Active comparator | Participants receive 2 cycles of neoadjuvant toripalimab monotherapy. After the neoadjuvant phase, radical surgery is performed. Postoperative management is determined by pathology: participants with extranodal extension (ENE) or positive/inadequate margins receive adjuvant chemoradiotherapy (cisplatin 100 mg/m² every 3 weeks for 3 cycles plus radiotherapy at 60-70 Gy depending on risk), while those without receive adjuvant radiotherapy alone. During adjuvant radiotherapy, participants receive 3 cycles of concurrent toripalimab. After radiotherapy, all participants receive 12 cycles of adjuvant toripalimab maintenance therapy. Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response (MPR) rate
Proportion of patients with major pathological response, defined as ≤ 10% residual viable tumor in the primary tumor and all sampled lymph nodes after completion of neoadjuvant therapy.
Measured: At the time of surgical specimen evaluation (approximately 6-8 weeks after initiation of neoadjuvant therapy)
Secondary outcomes (6)
Event-Free Survival (EFS)
Time from randomization to first documented radiographic progression, progression leading to inoperability, or death from any cause.
Measured: From randomization up to approximately 36 months
Pathologic Complete Response (pCR) Rate
Proportion of subjects with no residual viable tumor cells in the primary tumor bed or resected lymph nodes after neoadjuvant therapy.
Measured: At definitive surgery (approximately Week 6-8 after randomization)
Objective Response Rate (ORR) per RECIST 1.1
Proportion of subjects achieving complete response (CR) or partial response (PR) according to RECIST 1.1 after 2 cycles of neoadjuvant therapy.
Measured: After completion of 2 cycles of neoadjuvant therapy (approximately Week 6)
Safety: Incidence of Adverse Events and Serious Adverse Events
Incidence, severity, and relationship of adverse events (AEs) and serious adverse events (SAEs) graded by CTCAE v5.0.
Measured: From first dose of study drug through 90 days after last dose or 30 days after surgery, whichever occurs later
On-Time Surgery Rate
Proportion of subjects who undergo radical surgery within 49 days after Cycle 2 Day 1 of neoadjuvant therapy.
Measured: Within 49 days after Cycle 2 Day 1（ (each cycle is 21 days)）
R0 Resection Rate
Proportion of subjects who achieve complete (microscopically margin-negative) resection at definitive surgery.
Measured: At definitive surgery (approximately Week 6-8 after randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start10 Aug 2026 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Jun 2029 (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 CarcinomaStudies 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
- Model description
- This is a randomized, parallel-arm, open-label, Phase 2 clinical trial. Eligible patients are randomized in a 2:1 ratio to receive either neoadjuvant MRG003 (Becotatug vedotin) plus toripalimab (Experimental Arm) or neoadjuvant toripalimab monotherapy (Control Arm).
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongguan People's Hospital
- Sponsor type
- Other government
- Collaborators
- Sun Yat-Sen University Cancer Center, Shenzhen People's Hospital, Peking University Shenzhen Hospital, The University of Hong Kong-Shenzhen Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Huizhou Municipal Central Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Zhigang Liu, MD, Study chair, The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677475
- Sponsor's protocol ID
- IIT-2026-008
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not currently have a plan to share individual participant data. The research team will not provide access to the raw data set.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRG003 (Becotatug Vedotin) Plus Toripalimab Versus Toripalimab as Neoadjuvant Therapy for PD-L1-Positive, Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma: A Multicenter, Prospective, Randomized, Controlled Phase II Trial
- ClinicalTrials.gov ID
- NCT07677475
- Acronym / sponsor ID
- IIT-2026-008
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- MRG003, Vebecototagene Autoleucovorin, Toripalimab, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Dongguan People's HospitalOther government
- Collaborators
- Sun Yat-Sen University Cancer Center, Shenzhen People's Hospital, Peking University Shenzhen Hospital, The University of Hong Kong-Shenzhen Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Huizhou Municipal Central Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 30 Jun 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 is a multicenter, prospective, randomized, controlled Phase II trial evaluating the safety and efficacy of MRG003 (Becotatug vedotin) combined with Toripalimab versus Toripalimab alone as neoadjuvant therapy for PD-L1-positive, resectable locally advanced head and neck squamous cell carcinoma. A total of 65 subjects are planned (43 experimental, 22 control). The experimental arm receives two cycles of MRG003 (Becotatug vedotin) 2.0 mg/kg intravenously on Day 1 followed by Toripalimab 240 mg intravenously on Day 1 every 3 weeks, while the control arm receives two cycles of Toripalimab 240 mg alone. After neoadjuvant therapy, both arms undergo radical surgery 3-4 weeks later, followed by risk-adapted adjuvant radiotherapy or chemoradiotherapy with concurrent Toripalimab (3 cycles) and then 12 cycles of adjuvant Toripalimab maintenance. The primary endpoint is the major pathological response rate.
Detailed description
This study builds upon the limitations of neoadjuvant immunotherapy monotherapy (e.g., KEYNOTE-689), which showed a low MPR rate (9.8% overall, 13.7% in CPS>10) and a 25.6% progression rate, by exploring the synergistic combination of the EGFR-targeting antibody-drug conjugate MRG (Becotatug vedotin) with the PD-1 inhibitor Toripalimab. Eligible patients are treatment-naïve, PD-L1 positive (CPS ≥1), stage III-IVA resectable non-oropharyngeal, HPV-negative oropharyngeal, or specific HPV-positive oropharyngeal HNSCC, ECOG PS 0-1, aged 18-70. In the neoadjuvant phase, the experimental group receives MRG (Becotatug vedotin) 2.0 mg/kg (based on actual body weight) intravenously without prophylactic premedication, followed by Toripalimab 240 mg intravenously over 30-60 minutes on Day 1 of each 3-week cycle for 2 cycles; infusion reactions are monitored for at least 120 minutes after the first dose and 60 minutes thereafter. Dose reduction of MRG (Becotatug vedotin) to 1.5 mg/kg is permitted for toxicity, with permanent discontinuation if intolerance persists; Toripalimab dose modification is not allowed. The control group receives Toripalimab 240 mg alone on the same schedule. Three to four weeks after Cycle 2 Day 1, both arms undergo radical tumor resection; surgery is performed even if radiological progression occurs during neoadjuvant therapy, provided surgical criteria are met. Postoperatively, patients are stratified by pathology: those with extranodal extension or positive/inadequate margins receive adjuvant chemoradiotherapy (cisplatin 100 mg/m² every 3 weeks for 3 cycles plus radiotherapy at 60-70 Gy depending on risk), while those without receive adjuvant radiotherapy alone (same doses). During adjuvant radiotherapy, both arms concurrently receive 3 cycles of Toripalimab 240 mg every 3 weeks. After completing radiotherapy, all patients receive 12 cycles of adjuvant Toripalimab 240 mg every 3 weeks as maintenance. Secondary endpoints include event-free survival, pathologic complete response rate, objective response rate, R0 resection rate, surgical down-staging rate, safety (CTCAE v6.0), and quality of life; exploratory endpoints include overall survival and biomarker analysis. The MPR rate is compared using the exact test, assuming 45% in the experimental arm versus approximately 9.8% in the historical control, with a one-sided alpha of 0.025, 80% power, and 10% dropout, yielding the required sample size of 65. The full analysis set is the primary analysis population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-arm, open-label, Phase 2 clinical trial. Eligible patients are randomized in a 2:1 ratio to receive either neoadjuvant MRG003 (Becotatug vedotin) plus toripalimab (Experimental Arm) or neoadjuvant toripalimab monotherapy (Control Arm).
| Arm | Type | Receives |
|---|---|---|
| MRG003 + Toripalimab | Experimental | Drug: MRG003 (Becotatug vedotin) and Toripalimab, Drug: ToripalimabParticipants receive 2 cycles of neoadjuvant combination therapy with toripalimab plus MRG003 (Becotatug vedotin). After the neoadjuvant phase, radical surgery is performed. Postoperative management follows the same risk-adapted criteria as the control arm: participants with ENE or positive/inadequate margins receive adjuvant chemoradiotherapy, while those without receive adjuvant radiotherapy alone. During adjuvant radiotherapy, participants receive 3 cycles of concurrent toripalimab. After radiotherapy, all participants receive 12 cycles of adjuvant toripalimab maintenance therapy. |
| Toripalimab Monotherapy | Active comparator | Drug: ToripalimabParticipants receive 2 cycles of neoadjuvant toripalimab monotherapy. After the neoadjuvant phase, radical surgery is performed. Postoperative management is determined by pathology: participants with extranodal extension (ENE) or positive/inadequate margins receive adjuvant chemoradiotherapy (cisplatin 100 mg/m² every 3 weeks for 3 cycles plus radiotherapy at 60-70 Gy depending on risk), while those without receive adjuvant radiotherapy alone. During adjuvant radiotherapy, participants receive 3 cycles of concurrent toripalimab. After radiotherapy, all participants receive 12 cycles of adjuvant toripalimab maintenance therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MRG003 (Becotatug vedotin) and ToripalimabToripalimab 240 mg administered intravenously over 30-60 minutes on Day 1 of each 3-week cycle, followed immediately by MRG003 (Becotatug vedotin) 2.0 mg/kg (based on actual body weight) administered intravenously without prophylactic premedication. Neoadjuvant phase: 2 cycles of both drugs. Adjuvant toripalimab: 3 cycles concurrent with radiotherapy, then 12 cycles maintenance. For MRG003 (Becotatug vedotin), monitor infusion reactions for at least 120 minutes after first dose and at least 60 minutes after subsequent doses if tolerated. Dose reduction of MRG003 (Becotatug vedotin) to 1.5 mg/kg is permitted once for toxicity; permanent discontinuation if intolerance persists at reduced dose. Toripalimab dose remains fixed throughout; no dose modification is permitted. | Drug | MRG003 + Toripalimab |
| ToripalimabToripalimab 240 mg administered intravenously over 30-60 minutes on Day 1 of each 3-week cycle. Neoadjuvant phase: 2 cycles. Adjuvant phase (concurrent with radiotherapy): 3 cycles. Adjuvant maintenance (after radiotherapy): 12 cycles. No prophylactic premedication required. No dose modification of toripalimab is permitted. | Drug | MRG003 + Toripalimab, Toripalimab Monotherapy |
Primary outcome
Major Pathological Response (MPR) rate
Time frame: At the time of surgical specimen evaluation (approximately 6-8 weeks after initiation of neoadjuvant therapy)
Proportion of patients with major pathological response, defined as ≤ 10% residual viable tumor in the primary tumor and all sampled lymph nodes after completion of neoadjuvant therapy.
6 secondary outcomes
Event-Free Survival (EFS)
Time frame: From randomization up to approximately 36 months
Pathologic Complete Response (pCR) Rate
Time frame: At definitive surgery (approximately Week 6-8 after randomization)
Objective Response Rate (ORR) per RECIST 1.1
Time frame: After completion of 2 cycles of neoadjuvant therapy (approximately Week 6)
Safety: Incidence of Adverse Events and Serious Adverse Events
Time frame: From first dose of study drug through 90 days after last dose or 30 days after surgery, whichever occurs later
On-Time Surgery Rate
Time frame: Within 49 days after Cycle 2 Day 1（ (each cycle is 21 days)）
R0 Resection Rate
Time frame: At definitive surgery (approximately Week 6-8 after randomization)
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 5 Aug 2026.
- Individual participant dataSharing planned: No. This study does not currently have a plan to share individual participant data. The research team will not provide access to the raw data set.
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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.
Zhigang Liu, MD study chair
The Tenth Affiliated Hospital of Southern Medical University (Dongguan People's Hospital)
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 MRG003 (Becotatug vedotin) and Toripalimab and Toripalimab in people with Head and Neck Squamous Cell Carcinoma, run by Dongguan People's Hospital 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?
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 5 Aug 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 Liji Jiang, Master (0769-28637916, keynotejiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response (MPR) rate (time frame: At the time of surgical specimen evaluation (approximately 6-8 weeks after initiation of neoadjuvant therapy)). 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 5 Aug 2026.