Esophageal Squamous Cell CarcinomaPhase 2NCT07699185
Neoadjuvant Cardonilizumab Combined With Neoadjuvant Chemoradiotherapy Can Resect Locally Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Cardonilizumab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Tongji Hospital at 1 site in China.
Trial summary
This is a multicenter, open-label, randomized, controlled clinical study to compare the efficacy and safety of cardonilizumab combined with neoadjuvant chemotherapy and surgery versus neoadjuvant chemoradiotherapy and surgery in locally advanced ESCC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Cardonilizumab, Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2024to 1 Jul 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent before implementing any procedures related to the trial;
- Male or female, 18 years old ≤75 years old;
- Patients with histologically proven ESCC with a pathological stage of cT1N2M0 or cT2-3N0-2M0 according to AJCC Version 8 TNM stage and eligible for R0 surgical resection prior to treatment;
- Have not received systematic treatment for the current disease, including surgical treatment, anti-tumor chemoradiotherapy/immunotherapy, etc.;
- Patients who agree to radical surgical treatment and are judged by the surgeon to have no surgical contraindications;
- ECOG score 0-1;
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- Expected survival time >6 months;
- For adequate organ function, subjects must meet the following laboratory criteria:
- For adequate organ function, subjects must meet the following laboratory criteria:
- The absolute value of neutrophil (ANC) ≥1.5x109/L in the past 14 days without the use of granulocyte colony-stimulating factor;
- Platelets ≥100×109/L without blood transfusion in the past 14 days;
- Hemoglobin >9g/dL in the last 14 days without blood transfusion or use of erythropoietin;
- Total bilirubin ≤1.5× upper limit of normal (ULN);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are ≤2.5×ULN
- Serum creatinine ≤1.5×ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min;
- Good coagulation function, defined as International standardized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;
- Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
- The myocardial enzyme profile was within the normal range (if the researcher comprehensively judged that the simple laboratory abnormality was not clinically significant, it was also allowed to be included);
- For female subjects of reproductive age, a urine or serum pregnancy test should be performed within 3 days prior to receiving the first study drug administration (day 1 of cycle 1) and the results are negative. If the urine pregnancy test results cannot be confirmed as negative, a blood pregnancy test is requested. Women of non-reproductive age were defined as at least one year after menopause or having undergone surgical sterilization or hysterectomy;
- If there is a risk of conception, all subjects (male or female) are required to use contraception with an annual failure rate of less than 1% for the entire duration of treatment up to 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Who cannot join
- Diagnosis of other malignant diseases (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection) within 1.5 years;
- Known endoscopic signs of active bleeding;
- Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing;
- Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that respond to another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.);
- Received systemic systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration;
- An active autoimmune disease requiring systemic treatment (e.g. with disease-modifying drugs, glucocorticoids, or immunosuppressants) has occurred within 2 years prior to first administration. Replacement therapies (such as thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic therapy;
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- Was receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhalation, or other route) or any other form of immunosuppressive therapy within 7 days prior to the study's initial administration; Note: The use of physiological doses of glucocorticoids (≤10 mg/ day of prednisone or equivalent) is permitted;
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Known allergy to the drugs used in this study;
- Has not fully recovered from toxicity and/or complications caused by any intervention before starting treatment (i.e., ≤ grade 1 or baseline, excluding weakness or hair loss);
- Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected greater than the upper limit of normal value in the laboratory of the study center); Note: Hepatitis B subjects who meet the following criteria can also be enrolled:
- HBV viral load <2500 copies /ml (500 IU/ml) prior to initial dosing, subjects should receive anti-HBV therapy throughout study chemotherapy therapy to avoid viral reactivation
- For subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring of viral reactivation is required
- Active HCV-infected subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);
- Received live vaccine within 30 days prior to the first dose (cycle 1, day 1);
- Note: It is permissible to receive injectable inactivated virus vaccine against seasonal influenza within 30 days prior to initial administration; However, live attenuated influenza vaccines administered intranasally are not permitted
- Pregnant or lactating women;
- The presence of any serious or uncontrolled systemic disease, such as:
- The resting electrocardiogram has major abnormal rhythm, conduction or morphology, such as complete left bundle branch block, heart block above Ⅱ degree, ventricular arrhythmia or atrial fibrillation;
- Unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;
- Any arterial thrombosis, embolism or ischemia occurred within 6 months before treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack;
- Poor blood pressure control (systolic > 140 mmHg, diastolic > 90 mmHg);
- There is a history of non-infectious pneumonia requiring glucocorticoid therapy within 1 year prior to first administration, or there is currently clinically active interstitial lung disease;
- Active pulmonary tuberculosis;
- There is an active or uncontrolled infection that requires systemic treatment;
- Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction;
- Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
- Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L);
- Urine routine indicated urine protein ≥++, and confirmed 24-hour urine protein quantity > 1.0 g;
- Patients with mental disorders who cannot cooperate with treatment; Evidence of medical history or disease that might interfere with the test results, prevent participants from fully participating in the study, abnormal treatment or laboratory test values, or other conditions that the investigator considers unsuitable for enrollment The Investigator considers other potential risks unsuitable for participation in the study.
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
Tongji hospital
Wuhan, Hubei, 430030
Wei Ping, Doctor, +8613437101581, 247046170@qq.com
About this study
Official title: Neoadjuvant Cardonilizumab Combined With Chemotherapy Versus Neoadjuvant Concurrent Chemoradiotherapy in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Multicenter, Open-label, Randomized, Controlled Study
This is a multicenter, open-label, randomized, controlled clinical study to compare the efficacy and safety of cardonilizumab combined with neoadjuvant chemotherapy and surgery versus neoadjuvant chemoradiotherapy and surgery in locally advanced ESCC. Subjects were randomly divided into experimental group and control group, the experimental group received neoadjuvant immunotherapy concurrent chemotherapy regimen, the control group received neoadjuvant concurrent chemoradiotherapy regimen, and then received McKeown surgery. The primary outcome measures were complete pathological response (pCR), and the secondary outcome measures were major pathological response (MPR), EFS (event-free survival), OS (overall survival), overall response rate (ORR), decreased pathological stage, R0 resection rate, adverse events (AE), and perioperative complications
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Cardonilizumab, Paclitaxel, Cisplatin, neoadjuvant chemoradiotherapy
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardonilizumabBiological
Cardonilizumab 10 mg/kg, once every 3 weeks, will be administered intravenously as an infusion of 120 minutes (±10 minutes). The investigator continuously monitors potential infusion responses and pretreats hypersensitivity reactions and/or adjusts the infusion rate as recommended by the protocol. For subjects who cannot tolerate a 120-minute infusion, the infusion time can be extended to a maximum of 240 minutes. Within 72 hours prior to each dosing, subjects were required to complete a series of tests including vital signs, physical examination, laboratory tests, and fitness status scores to assess the safety and tolerability of continued treatment
PaclitaxelDrug
paclitaxel 135mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery
CisplatinDrug
Cisplatin 80mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery
neoadjuvant chemoradiotherapyRadiation
Radiotherapy: 40 Gy (2Gy×20 times), 5 times/week for 5 consecutive weeks; Chemotherapy: paclitaxel 50mg/m2+ cisplatin 25mg/m2 once a week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cardonilizumab+Paclitaxel+Cisplatin+ Surgery（168） | Experimental | Cardonilizumab 10 mg/kg, once every 3 weeks, will be administered intravenously as an infusion of 120 minutes (±10 minutes). The investigator continuously monitors potential infusion responses and pretreats hypersensitivity reactions and/or adjusts the infusion rate as recommended by the protocol. For subjects who cannot tolerate a 120-minute infusion, the infusion time can be extended to a maximum of 240 minutes. Within 72 hours prior to each dosing, subjects were required to complete a series of tests including vital signs, physical examination, laboratory tests, and fitness status scores to assess the safety and tolerability of continued treatment
Paclitaxel 135mg/m2, intravenous infusion on the second day, once /3 weeks, 3 consecutive cycles before surgery; Cisplatin 80mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery
Surgery: McKeown esophagectomy
Interventions:
Biological: Cardonilizumab Drug: Paclitaxel Drug: Paclitaxel Receives: Biological: Cardonilizumab; Drug: Paclitaxel; Drug: Cisplatin |
| neoadjuvant chemoradiotherapy+ Surgery（168） | Experimental | Radiotherapy: 40 Gy (2Gy×20 times), 5 times/week for 5 consecutive weeks; Chemotherapy: paclitaxel 50mg/m2+ cisplatin 25mg/m2 once a week for 4 weeks. The control group was followed up after R0 resection or adjusted according to the guidelines
Surgery: McKeown esophagectomy
Interventions:
Radiation: neoadjuvant chemoradiotherapy Receives: Radiation: neoadjuvant chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response Rate
Percentage of participants with pathologic complete response, defined as no viable tumor cells in all resected tumor specimens and sampled regional lymph nodes after neoadjuvant treatment.
Measured: At surgery, after completion of neoadjuvant treatment
Secondary outcomes (8)
Major Pathologic Response Rate
Percentage of participants with major pathologic response, defined as 10% or less residual viable tumor cells in the resected tumor specimens after neoadjuvant treatment.
Measured: At the time of pathological assessment after surgery
Event-Free Survival
Time from randomization to disease progression precluding surgery, local recurrence, distant metastasis, or death from any cause, whichever occurs first.
Measured: From randomization up to 5 years
Overall Survival
Time from randomization to death from any cause.
Measured: From randomization up to 5 years
Objective Response Rate Assessed by RECIST v1.1
Percentage of participants with complete response or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1.
Measured: From baseline to preoperative tumor assessment after neoadjuvant treatment
Pathologic Downstaging Rate Based on TNM Staging
Percentage of participants with a decrease in pathological TNM stage after neoadjuvant treatment compared with baseline clinical TNM stage.
Measured: At the time of pathological assessment after surgery
R0 Resection Rate
Percentage of participants who undergo microscopically margin-negative resection.
Measured: At surgery
Number of Participants With Adverse Events Assessed by CTCAE v5.0
Number of participants with adverse events graded according to the Common Terminology Criteria for Adverse Events version 5.0.
Measured: From informed consent to the end of safety follow-up
Number of Participants With Perioperative Complications Assessed by Clavien-Dindo Classification
Number of participants with perioperative complications graded according to the Clavien-Dindo classification.
Measured: From surgery to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start29 Jan 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Ni, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699185
- Sponsor's protocol ID
- 2024TJCR007
- Status last verified
- Jul 2026
- First submitted
- 22 Dec 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Cardonilizumab Combined With Chemotherapy Versus Neoadjuvant Concurrent Chemoradiotherapy in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Multicenter, Open-label, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07699185
- Acronym / sponsor ID
- 2024TJCR007
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 13 Jul 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, open-label, randomized, controlled clinical study to compare the efficacy and safety of cardonilizumab combined with neoadjuvant chemotherapy and surgery versus neoadjuvant chemoradiotherapy and surgery in locally advanced ESCC. Subjects were randomly divided into experimental group and control group, the experimental group received neoadjuvant immunotherapy concurrent chemotherapy regimen, the control group received neoadjuvant concurrent chemoradiotherapy regimen, and then received McKeown surgery. The primary outcome measures were complete pathological response (pCR), and the secondary outcome measures were major pathological response (MPR), EFS (event-free survival), OS (overall survival), overall response rate (ORR), decreased pathological stage, R0 resection rate, adverse events (AE), and perioperative complications
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardonilizumab+Paclitaxel+Cisplatin+ Surgery（168） | Experimental | Biological: Cardonilizumab, Drug: Paclitaxel, Drug: CisplatinCardonilizumab 10 mg/kg, once every 3 weeks, will be administered intravenously as an infusion of 120 minutes (±10 minutes). The investigator continuously monitors potential infusion responses and pretreats hypersensitivity reactions and/or adjusts the infusion rate as recommended by the protocol. For subjects who cannot tolerate a 120-minute infusion, the infusion time can be extended to a maximum of 240 minutes. Within 72 hours prior to each dosing, subjects were required to complete a series of tests including vital signs, physical examination, laboratory tests, and fitness status scores to assess the safety and tolerability of continued treatment Paclitaxel 135mg/m2, intravenous infusion on the second day, once /3 weeks, 3 consecutive cycles before surgery; Cisplatin 80mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery Surgery: McKeown esophagectomy Interventions: Biological: Cardonilizumab Drug: Paclitaxel Drug: Paclitaxel |
| neoadjuvant chemoradiotherapy+ Surgery（168） | Experimental | Radiation: neoadjuvant chemoradiotherapyRadiotherapy: 40 Gy (2Gy×20 times), 5 times/week for 5 consecutive weeks; Chemotherapy: paclitaxel 50mg/m2+ cisplatin 25mg/m2 once a week for 4 weeks. The control group was followed up after R0 resection or adjusted according to the guidelines Surgery: McKeown esophagectomy Interventions: Radiation: neoadjuvant chemoradiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Sign a written informed consent before implementing any procedures related to the trial;
- Male or female, 18 years old ≤75 years old;
- Patients with histologically proven ESCC with a pathological stage of cT1N2M0 or cT2-3N0-2M0 according to AJCC Version 8 TNM stage and eligible for R0 surgical resection prior to treatment;
- Have not received systematic treatment for the current disease, including surgical treatment, anti-tumor chemoradiotherapy/immunotherapy, etc.;
- Patients who agree to radical surgical treatment and are judged by the surgeon to have no surgical contraindications;
Key exclusion criteria (31 listed)
- Diagnosis of other malignant diseases (excluding radical basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection) within 1.5 years;
- Known endoscopic signs of active bleeding;
- Is currently participating in an interventional clinical study, or has received other investigational drugs or used investigational devices within 4 weeks prior to initial dosing;
- Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that respond to another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.);
- Received systemic systemic treatment with Chinese patent drugs with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to control pleural fluid) within 2 weeks before the first administration;
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 |
|---|---|---|
| CardonilizumabCardonilizumab 10 mg/kg, once every 3 weeks, will be administered intravenously as an infusion of 120 minutes (±10 minutes). The investigator continuously monitors potential infusion responses and pretreats hypersensitivity reactions and/or adjusts the infusion rate as recommended by the protocol. For subjects who cannot tolerate a 120-minute infusion, the infusion time can be extended to a maximum of 240 minutes. Within 72 hours prior to each dosing, subjects were required to complete a series of tests including vital signs, physical examination, laboratory tests, and fitness status scores to assess the safety and tolerability of continued treatment | Biological | Cardonilizumab+Paclitaxel+Cisplatin+ Surgery（168） |
| Paclitaxelpaclitaxel 135mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery | Drug | Cardonilizumab+Paclitaxel+Cisplatin+ Surgery（168） |
| CisplatinCisplatin 80mg/m2, intravenous infusion on day 2, once /3 weeks, 3 consecutive cycles before surgery | Drug | Cardonilizumab+Paclitaxel+Cisplatin+ Surgery（168） |
| neoadjuvant chemoradiotherapyRadiotherapy: 40 Gy (2Gy×20 times), 5 times/week for 5 consecutive weeks; Chemotherapy: paclitaxel 50mg/m2+ cisplatin 25mg/m2 once a week for 4 weeks | Radiation | neoadjuvant chemoradiotherapy+ Surgery（168） |
Primary outcome
Pathologic Complete Response Rate
Time frame: At surgery, after completion of neoadjuvant treatment
Percentage of participants with pathologic complete response, defined as no viable tumor cells in all resected tumor specimens and sampled regional lymph nodes after neoadjuvant treatment.
8 secondary outcomes
Major Pathologic Response Rate
Time frame: At the time of pathological assessment after surgery
Event-Free Survival
Time frame: From randomization up to 5 years
Overall Survival
Time frame: From randomization up to 5 years
Objective Response Rate Assessed by RECIST v1.1
Time frame: From baseline to preoperative tumor assessment after neoadjuvant treatment
Pathologic Downstaging Rate Based on TNM Staging
Time frame: At the time of pathological assessment after surgery
R0 Resection Rate
Time frame: At surgery
Number of Participants With Adverse Events Assessed by CTCAE v5.0
Time frame: From informed consent to the end of safety follow-up
Number of Participants With Perioperative Complications Assessed by Clavien-Dindo Classification
Time frame: From surgery to 30 days after surgery
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 Jul 2026.
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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 Cardonilizumab, Paclitaxel and Cisplatin in people with Esophageal Squamous Cell Carcinoma, run by Tongji 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?
The sponsor lists 20 inclusion and 31 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 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 Ni Zhang (13871288490, zhangnidoc@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response Rate (time frame: At surgery, after completion of neoadjuvant treatment). 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 Jul 2026.