Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 3NCT07524452
Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma
A Phase 3 study testing Neoadjuvant and Adjuvant Becotatug Vedotin, Neoadjuvant and Adjuvant Immunotherapy and Surgery in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Ming-Yuan Chen at 1 site in China.
Trial summary
This study is a randomized, open-label, multicenter phase III trial designed to systematically evaluate the efficacy and safety of perioperative neoadjuvant and adjuvant therapy with Becotatug vedotin in combination with PD-1 inhibitor versus PD-1 inhibitor alone in patients with EGFR-positive, CPS ≥ 1 resectable… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- What is being tested?
- Neoadjuvant and Adjuvant Becotatug Vedotin, Neoadjuvant and Adjuvant Immunotherapy and Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2026to 28 Feb 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form;
- Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx), EGFR-positive, CPS ≥ 1, with clinical stage (AJCC 8th edition): p16-positive oropharynx: Stage III (T4N0-2M0); p16-negative oropharynx: Stage III or IVA; larynx/hypopharynx/oral cavity: Stage III or IVA;
- Eligible for curative-intent surgery as determined by the surgeon;
- Age: 18 to 75 years;
- ECOG performance status 0-1;
- Life expectancy greater than 6 months;
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- At least one measurable lesion per RECIST 1.1;
- Adequate organ function, based on meeting all of the following criteria (no receipt of blood components or hematopoietic growth factors within 14 days prior to testing): hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10⁹/L; platelet count ≥ 100 × 10⁹/L; serum albumin ≥ 28 g/L; total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN, with creatinine clearance ≥ 50 mL/min; activated partial thromboplastin time and international normalized ratio (INR) ≤ 1.5 × ULN (patients receiving a stable dose of anticoagulant therapy, such as low molecular weight heparin or warfarin, may be enrolled if INR is within the expected therapeutic range for the anticoagulant). Thyroid-stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be assessed, and patients with normal T3 and T4 levels may be enrolled;
- Baseline left ventricular ejection fraction (LVEF) ≥ 50% as measured by multigated acquisition (MUGA) scan or echocardiography (ECHO);
- Women of childbearing potential must agree to use contraception (e.g., intrauterine device, contraceptive pill, or condom) during the treatment period and for 3 months after the last dose;
- Good compliance.
Who cannot join
- Pregnant or breastfeeding women.
- History of allergy to PD-1 inhibitors.
- History of other malignancies within the past 5 years or at enrollment, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and thyroid papillary tumors.
- Residual toxicity from prior anti-tumor therapy (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy, etc.) other than alopecia, fatigue, and grade 2 hypothyroidism, or clinically significant laboratory abnormalities greater than grade 1 (CTCAE v5.0).
- Uncontrolled cardiac conditions or diseases, such as: ① NYHA Class II or greater heart failure, ② unstable angina, ③ myocardial infarction within 1 year, and ④ patients with clinically significant ventricular arrhythmias requiring intervention.
- Grade ≥ 2 peripheral neuropathy (per CTCAE v5.0).
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- Pulmonary embolism or deep vein thrombosis within 3 months prior to enrollment (excluding catheter-related thrombosis from infusion ports or PICC lines).
- Active bleeding, history of coagulation disorders, or patients receiving coumarin anticoagulant therapy.
- Known hypersensitivity to any component or excipient of vibecotamab (citric acid monohydrate, sodium citrate dihydrate, trehalose dihydrate, sodium chloride, and polysorbate 80), or known grade ≥ 3 hypersensitivity reaction to other prior anti-EGFR agents (including investigational drugs) or other monoclonal antibodies.
- Receipt of any of the following treatments:
- ① Any investigational drug prior to the first dose of the current study drug.
- ② Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period.
- ③ Use of systemic corticosteroids (more than 10 mg of prednisone or equivalent per day) or other immunosuppressive agents within 2 weeks prior to the first dose of study drug, except for the use of corticosteroids for localized inflammation, prevention of allergies, or nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacement doses greater than 10 mg prednisone equivalent per day are permitted.
- ④ Administration of live vaccines within 4 weeks prior to the first dose of study drug.
- ⑤ Major surgery or severe trauma within 4 weeks prior to the first dose of study drug.
- Severe infection (greater than grade 2 per CTCAE), such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications, occurring within 4 weeks prior to the first dose of study drug; baseline chest imaging indicating active pulmonary inflammation or signs and symptoms of infection within 2 weeks prior to the first dose of study drug, or indicating the need for oral or intravenous antibiotic therapy (excluding prophylactic antibiotic use).
- History of or concurrent severe chronic obstructive pulmonary disease with respiratory failure, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
- History of active autoimmune diseases or syndromes (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism). Patients with vitiligo that did not require any intervention in adulthood, or childhood asthma/allergy that has resolved, are not excluded.
- History of immunodeficiency, including HIV-positive status or other acquired/congenital immunodeficiency diseases, or history of organ transplantation or bone marrow transplantation.
- Patients with active tuberculosis infection by history or CT findings, or history of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year prior without receiving formal treatment.
- Active hepatitis B (HBV DNA ≥ 2,000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody test with HCV RNA above the lower limit of detection).
- Uncontrolled pleural, peritoneal, pelvic, or pericardial effusion requiring drainage ≥ 1 time per month.
- Known history of substance abuse, alcoholism, or drug use.
- Inappropriate for inclusion based on the investigator's judgment.
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 Fifth Affiliated Hospital,Sun Yat-sen University
Zhuhai, Guangdong, 519099
Rui You, 13580439820, your5@mail.sysu.edu.cn
About this study
Official title: A Phase III Study of Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma： a Multicenter, Randomized Controlled Trial
This study is a randomized, open-label, multicenter phase III trial designed to systematically evaluate the efficacy and safety of perioperative neoadjuvant and adjuvant therapy with Becotatug vedotin in combination with PD-1 inhibitor versus PD-1 inhibitor alone in patients with EGFR-positive, CPS ≥ 1 resectable locally advanced head and neck squamous cell carcinoma .
- Being tested
- Neoadjuvant and Adjuvant Becotatug Vedotin, Neoadjuvant and Adjuvant Immunotherapy, Surgery, Adjuvant Radiotherapy, Adjuvant Cisplatin
- Keywords
- Resectabl locally advanced head and neck squamous cell carcinoma, Becotatug Vedotin, perioperative neoadjuvant and adjuvant therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant and Adjuvant Becotatug VedotinDrug
Neoadjuvant therapy with Becotatug Vedotin (Day 1, Q3W, 2 cycles); Adjuvant therapy after radiotherapy with Becotatug Vedotin ( Day 1, Q3W, for a total of 12 cycles).
Neoadjuvant and Adjuvant ImmunotherapyDrug
Neoadjuvant immunotherapy with pucotenlimab (200mg, Day 1, Q3W, 2 cycles); Adjuvant immunotherapy duiring and after radiotherapy with pucotenlimab (200mg, Day 1, Q3W, for a total of 15 cycles).
SurgeryProcedure or surgery
Radical surgery performed 3-4 weeks after neoadjuvant therapy, following a re-evaluation of surgical indications by the surgeon.
Adjuvant RadiotherapyRadiation
Radiotherapy is initiated 4-6 weeks after surgery. For the low-risk group, a total dose of 60 Gy in 30 fractions is delivered using intensity-modulated radiation therapy (IMRT). For the high-risk group, 66 Gy in 33 fractions is prescribed, or 70 Gy in 35 fractions for residual lesions, also using IMRT.
Adjuvant CisplatinDrug
High-risk group：Cisplatin 100 mg/m² is administered via intravenous infusion on Day 1 of every 21-day cycle during radiotherapy, for a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Becotatug vedotin plus pucotenlimab arm | Experimental | Patients receive Becotatug vedotin combined with pucotenlimab as neoadjuvant treatment prior to surgical resection and as adjuvant treatment after radiotherapy. Receives: Drug: Neoadjuvant and Adjuvant Becotatug Vedotin; Drug: Neoadjuvant and Adjuvant Immunotherapy; Procedure: Surgery; Radiation: Adjuvant Radiotherapy; Drug: Adjuvant Cisplatin |
| pucotenlimab arm | Active comparator | Patients receive pucotenlimab as neoadjuvant treatment prior to surgical resection and as adjuvant duiring and after radiotherapy. Receives: Drug: Neoadjuvant and Adjuvant Immunotherapy; Procedure: Surgery; Radiation: Adjuvant Radiotherapy; Drug: Adjuvant Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival Rate (EFS)
Defined as the time from randomization to the first occurrence of disease progression, relapse, or death from any cause.
Measured: 3 years
Secondary outcomes (13)
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Measured: 3 years
Distant Metastasis-Free Survival (DMFS)
Defined as the time interval from randomisation to the date of first distant metastases.
Measured: 3 years
Locoregional Relapse-Free Survival (LRRFS)
Defined as the time from randomisation to the date of first locoregional relapse.
Measured: 3 years
Objective Response Rate (ORR)
The proportion of patients achieving an objective response (complete response and partial response) by imaging assessment after the completion of neoadjuvant therapy, prior to surgery.
Measured: After the completion of neoadjuvant therapy, prior to surgery.
Disease Control Rate (DCR)
The proportion of patients achieving predefined efficacy evaluation criteria (complete response, partial response, and stable disease) by imaging assessment after the completion of neoadjuvant therapy, prior to surgery.
Measured: After the completion of neoadjuvant therapy, prior to surgery.
Major Pathologic Response Rate (mPR):
The proportion of patients with less than 10% residual viable tumor cells in the tumor bed, assessed at 1 week post-surgery.
Measured: 1 week post-surgery
Pathologic Complete Response Rate (pCR)
The proportion of patients with no microscopic residual viable tumor cells, assessed at 1 week post-surgery.
Measured: 1 week post-surgery
Incidence of treatment related acute complications
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Measured: up to 1 year
Incidence of treatment related late complications
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Measured: up to 3 years
Non-Surgery Delay Rate
The proportion of patients whose surgery is delayed by more than 4 weeks from the planned date, assessed at 8 weeks after two cycles of neoadjuvant therapy.
Measured: 8 weeks after two cycles of neoadjuvant therapy
R0 Resection Rate
The proportion of patients undergoing surgical resection who achieve R0 resection (complete tumor resection with negative histopathological margins), assessed at 1 week post-surgery.
Measured: 1 week post-surgery.
General Quality of Life
Changes from baseline in general patient-reported quality of life were assessed using the EORTC QLQ-C30 . The scores range from 0 to 100, with higher scores indicating a better quality of life outcome and lower scores indicating worse symptoms or functions.
Measured: Baseline, week 4 (post-neoadjuvant), week 6 (preoperative), week 8 (postoperative), week 10 (pre-radiotherapy), week 17 (post-radiotherapy), every 2 cycles of adjuvant therapy (each cycle is 21 days), and at each follow-up, up to 3 years
Head and Neck Cancer-Specific Quality of Life
Changes from baseline in head and neck cancer-specific quality of life assessed by EORTC QLQ-H\&N35. The scores range from 0 to 100, with higher scores indicating a better quality of life outcome and lower scores indicating worse symptoms or functions.
Measured: Baseline, week 4 (post-neoadjuvant), week 6 (preoperative), week 8 (postoperative), week 10 (pre-radiotherapy), week 17 (post-radiotherapy), every 2 cycles of adjuvant therapy (each cycle is 21 days), and at each follow-up, up to 3 years.
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 start6 Feb 2026
- Primary completion28 Feb 2031 (estimated)
- Study completion28 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ming-Yuan Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ming-Yuan Chen, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524452
- Sponsor's protocol ID
- ZDWY.FSZLK.006
- Status last verified
- Feb 2026
- First submitted
- 28 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of Becotatug Vedotin (MRG003) in Combination With PD-1 Inhibitor Versus PD-1 Inhibitor for the Treatment of EGFR-positive, CPS≥1 Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma： a Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07524452
- Acronym / sponsor ID
- ZDWY.FSZLK.006
- Keywords
- Resectabl locally advanced head and neck squamous cell carcinoma, Becotatug Vedotin, perioperative neoadjuvant and adjuvant therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Ming-Yuan ChenUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 28 Feb 2031 (estimated)
- Study completion
- 28 Feb 2032 (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 study is a randomized, open-label, multicenter phase III trial designed to systematically evaluate the efficacy and safety of perioperative neoadjuvant and adjuvant therapy with Becotatug vedotin in combination with PD-1 inhibitor versus PD-1 inhibitor alone in patients with EGFR-positive, CPS ≥ 1 resectable locally advanced head and neck squamous cell carcinoma .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Becotatug vedotin plus pucotenlimab arm | Experimental | Drug: Neoadjuvant and Adjuvant Becotatug Vedotin, Drug: Neoadjuvant and Adjuvant Immunotherapy, Procedure: Surgery, Radiation: Adjuvant Radiotherapy, Drug: Adjuvant CisplatinPatients receive Becotatug vedotin combined with pucotenlimab as neoadjuvant treatment prior to surgical resection and as adjuvant treatment after radiotherapy. |
| pucotenlimab arm | Active comparator | Drug: Neoadjuvant and Adjuvant Immunotherapy, Procedure: Surgery, Radiation: Adjuvant Radiotherapy, Drug: Adjuvant CisplatinPatients receive pucotenlimab as neoadjuvant treatment prior to surgical resection and as adjuvant duiring and after radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily sign the informed consent form;
- Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx, or larynx), EGFR-positive, CPS ≥ 1, with clinical stage (AJCC 8th edition): p16-positive oropharynx: Stage III (T4N0-2M0); p16-negative oropharynx: Stage III or IVA; larynx/hypopharynx/oral cavity: Stage III or IVA;
- Eligible for curative-intent surgery as determined by the surgeon;
- Age: 18 to 75 years;
- ECOG performance status 0-1;
Key exclusion criteria (24 listed)
- Pregnant or breastfeeding women.
- History of allergy to PD-1 inhibitors.
- History of other malignancies within the past 5 years or at enrollment, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and thyroid papillary tumors.
- Residual toxicity from prior anti-tumor therapy (including immunotherapy, targeted therapy, chemotherapy, or radiotherapy, etc.) other than alopecia, fatigue, and grade 2 hypothyroidism, or clinically significant laboratory abnormalities greater than grade 1 (CTCAE v5.0).
- Uncontrolled cardiac conditions or diseases, such as: ① NYHA Class II or greater heart failure, ② unstable angina, ③ myocardial infarction within 1 year, and ④ patients with clinically significant ventricular arrhythmias requiring intervention.
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 |
|---|---|---|
| Neoadjuvant and Adjuvant Becotatug VedotinNeoadjuvant therapy with Becotatug Vedotin (Day 1, Q3W, 2 cycles); Adjuvant therapy after radiotherapy with Becotatug Vedotin ( Day 1, Q3W, for a total of 12 cycles). | Drug | Becotatug vedotin plus pucotenlimab arm |
| Neoadjuvant and Adjuvant ImmunotherapyNeoadjuvant immunotherapy with pucotenlimab (200mg, Day 1, Q3W, 2 cycles); Adjuvant immunotherapy duiring and after radiotherapy with pucotenlimab (200mg, Day 1, Q3W, for a total of 15 cycles). | Drug | Becotatug vedotin plus pucotenlimab arm, pucotenlimab arm |
| SurgeryRadical surgery performed 3-4 weeks after neoadjuvant therapy, following a re-evaluation of surgical indications by the surgeon. | Procedure or surgery | Becotatug vedotin plus pucotenlimab arm, pucotenlimab arm |
| Adjuvant RadiotherapyRadiotherapy is initiated 4-6 weeks after surgery. For the low-risk group, a total dose of 60 Gy in 30 fractions is delivered using intensity-modulated radiation therapy (IMRT). For the high-risk group, 66 Gy in 33 fractions is prescribed, or 70 Gy in 35 fractions for residual lesions, also using IMRT. | Radiation | Becotatug vedotin plus pucotenlimab arm, pucotenlimab arm |
| Adjuvant CisplatinHigh-risk group：Cisplatin 100 mg/m² is administered via intravenous infusion on Day 1 of every 21-day cycle during radiotherapy, for a total of 3 cycles. | Drug | Becotatug vedotin plus pucotenlimab arm, pucotenlimab arm |
Primary outcome
Event-Free Survival Rate (EFS)
Time frame: 3 years
Defined as the time from randomization to the first occurrence of disease progression, relapse, or death from any cause.
13 secondary outcomes
Overall Survival (OS)
Time frame: 3 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 3 years
Locoregional Relapse-Free Survival (LRRFS)
Time frame: 3 years
Objective Response Rate (ORR)
Time frame: After the completion of neoadjuvant therapy, prior to surgery.
Disease Control Rate (DCR)
Time frame: After the completion of neoadjuvant therapy, prior to surgery.
Major Pathologic Response Rate (mPR):
Time frame: 1 week post-surgery
Pathologic Complete Response Rate (pCR)
Time frame: 1 week post-surgery
Incidence of treatment related acute complications
Time frame: up to 1 year
Incidence of treatment related late complications
Time frame: up to 3 years
Non-Surgery Delay Rate
Time frame: 8 weeks after two cycles of neoadjuvant therapy
R0 Resection Rate
Time frame: 1 week post-surgery.
General Quality of Life
Time frame: Baseline, week 4 (post-neoadjuvant), week 6 (preoperative), week 8 (postoperative), week 10 (pre-radiotherapy), week 17 (post-radiotherapy), every 2 cycles of adjuvant therapy (each cycle is 21 days), and at each follow-up, up to 3 years
Head and Neck Cancer-Specific Quality of Life
Time frame: Baseline, week 4 (post-neoadjuvant), week 6 (preoperative), week 8 (postoperative), week 10 (pre-radiotherapy), week 17 (post-radiotherapy), every 2 cycles of adjuvant therapy (each cycle is 21 days), and at each follow-up, up to 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 13 Apr 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.
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 Neoadjuvant and Adjuvant Becotatug Vedotin, Neoadjuvant and Adjuvant Immunotherapy and Surgery in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Ming-Yuan Chen 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 11 inclusion and 24 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 13 Apr 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 Mingyuan Chen (+86 18124188280, chmingy@mail.sysu.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 Rate (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 13 Apr 2026.