Esophageal CancerPhase 2NCT05182944
A Study of Perioperative Camrelizumab Combined With Chemotherapy in Patients With Resectable ESCC
A Phase 2 study testing A：non-pCR patients, B：non-pCR patients and A：pCR patients in people with Esophageal Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- A：non-pCR patients, B：non-pCR patients and A：pCR patients
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2022to 15 Jan 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years, males or females；
- Histologically or cytologically confirmed as ESCC；
- Esophageal squamous cell carcinoma without anti-tumor treatment, and the clinical stage is T1b-2N+M0 or T3-4aN+/-M0 (AJCC/UICC TNM staging system 8th edition);
- It can provide tumor tissue for the detection of PD-L1 expression level;
- Follow-up surgery plan: radical esophageal squamous cell carcinoma surgery with esophagogastric reconstruction combined with at least complete 2 field lymph node dissection;
- ECOG: 0~1;
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- Expected survival time ≥ 12 weeks;
- Body mass index (BMI) ≥ 18.5kg/m2 or pg-sga score A / B;
- 1）White blood cell count (WBC) ≥3.0 × 109/L, absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet (PLT) count ≥100×109/L, hemoglobin (HGB) ≥90 g/L, No blood transfusion or other hematopoietic factor treatment for the previous 14 days； 2）Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN ; Albumin (ALB) ≥30g/L; 3）Serum creatinine (CRE)≤1.0×ULN, creatinine clearance (Ccr)≥60 mL/min (Cockcroft-Gault formula); 4）International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) ≤ 1.5 × ULN;
- Important organ functions: a) Heart function: normal or grade I; b) Lung function: FEV1>1.2L, FEV1% >40%; c) Liver function: Child-Pugh grade 5-6 points;
- For premenopausal women (postmenopausal women must have been postmenopausal for at least 12 months to be considered infertile), the serum pregnancy test result is negative. Male subjects (including male subjects' female spouses of childbearing age) and female subjects of childbearing age must contraception from the first study drug administration to 6 months after the last study drug administration；
- Obtain the informed consent signed by the subject or his legal representative;
- Can cooperate to complete research procedures and follow-up inspections。
Who cannot join
- Cervical esophageal squamous cell carcinoma;
- Combined with cervical, supraclavicular, abdominal, retroperitoneal and pelvic lymph node metastasis (except pericardial lymph node metastasis and left gastric lymph node metastasis);
- Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ；
- Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ；
- Previously active, potentially relapsed or undiagnosed autoimmune diseases, skin diseases (vitiligo, psoriasis, alopecia) without systemic treatment, well controlled type I diabetes, hypothyroidism (only thyroid hormone replacement therapy), and other diseases that were not expected to relapse under external stimulation were included.
- History of allogeneic stem cell transplantation or organ transplantation;
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- Complicated with interstitial pneumonia or interstitial lung disease, non infectious pneumonia;
- History of gastrointestinal perforation and/or fistula, abdominal abscess, visceral fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive within 6 months before the first study drug administration bowel resection (including partial colectomy or extensive small bowel resection with chronic diarrhea), Crohn's disease, ulcerative colitis or chronic diarrhea;
- Major operations (except puncture and biopsy) or major trauma were performed ≤ 28 days before the administration of the first study drug;
- Have vaccinated or plan to vaccinate live vaccine within 28 days before the first study drug administration;
- Use corticosteroids (>10 mg/day prednisone or equivalent dose) or other immunosuppressive agents within 14 days before the first study drug administration. Inhalation, ophthalmic, intra-articular, intranasal or topical corticosteroids can be used prophylactically for short-term (≤7 days) use of corticosteroids (for example, to prevent allergy to contrast agents) or for the treatment of non-autoimmune conditions (for example, delayed hypersensitivity caused by contact with allergens)
- Infectious diseases that affect activities of daily living or require systemic treatment (such as the use of hormones, antibiotics, antifungal drugs, antiviral drugs, and oxygen inhalation) within 14 days before the first study drug administration, including but not limited to the need Hospitalized infections, bacteremia, severe pneumonia, etc.;
- Combined with the following diseases that have not been well controlled, such as: a) New York Heart Association (NYHA) ≥ Grade 2 heart failure, b) Severe/Unstable Angina, c) Myocardial infarction ≤ 6 months before study administration, d) Severe arrhythmia requiring medication or intervention, e) Uncontrollable hypertension, f) Occurrence/combined arterial and/or venous thromboembolism ≤2 months before the first study administration, g) ≤6 before the first study administration A cerebrovascular accident occurred within a month, h) diabetes that has not been effectively controlled, i) thyroid disease that has not been effectively controlled, j) urine protein ≥ 2+ and 24-hour urine protein quantification ≥ 1.0g;
- Tuberculosis (TB) who has received anti-tuberculosis treatment within 1 year before receiving/receiving/first study administration;
- Human immunodeficiency virus infection (HIV1/2 antibody positive);
- Acute or chronic active hepatitis B and / or hepatitis C: positive for hepatitis B virus surface antigen (HBsAg) / positive for hepatitis B virus core antibody (HBcAb) and positive for hepatitis B virus DNA (HBV DNA >2000 IU/ml or 103 copies /ml), if HBsAg/HB cAb positive, HBV DNA less than 2000 IU/ml or 103 copies of /ml can be entered, but entecavir or other anti HBV drugs should be taken simultaneously; hepatitis C virus (positive) antibody is positive and HBV copies;
- Pregnant or lactating women;
- Complicated with other malignant tumors ≤5 years before the first study drug administration, various cancers in situ, skin basal cell carcinoma or squamous cell carcinoma that have been cured in the past, local prostate cancer after radical resection, and catheters after radical resection except for carcinoma in situ;
- Combined with other severe, acute, chronic or mental illness that may increase the risk of study medication or may interfere with the interpretation of the study results, the presence of alcoholism, drug abuse, or drug abuse, and other conditions that are not conducive to study drug administration, drug toxicity or adverse events (AE) Circumstances that lead to a decrease in the compliance of research behavior;
- Other circumstances that the researcher considers inappropriate to participate 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
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Song Zhao, 13673665008, zhaosong@zzu.cn
About this study
Official title: A Randomized, Controlled, Phase II Study of Perioperative Camrelizumab Combined With Albumin Paclitaxel and Cisplatin in Patients With Resectable Esophageal Squamous Cell Carcinoma
The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
Read the detailed description
The incidence of esophageal cancer is ranked seventh in the world, and the mortality rate ranks sixth in the world. Surgical treatment of early esophageal cancer has a good prognosis, and advanced esophageal cancer often requires a combination of surgery, chemotherapy, radiotherapy and immunotherapy, but the prognosis is still poor. The investigators designed a randomized, controlled, phase II study of perioperative camrelizumab combined with albumin paclitaxel and cisplatin in patients with resectable esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
- Conditions
- Esophageal Cancer
- Being tested
- A：non-pCR patients, B：non-pCR patients, A：pCR patients, B：pCR patients
- Keywords
- ESCC, perioperative, immune checkpoint inhibitor
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A：non-pCR patientsDrug
After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（2-4 cycles Camrelizumab+Albumin Paclitaxel+Cisplatin and Camrelizumab maintenance treatment）
Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication
B：non-pCR patientsDrug
After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（Camrelizumab maintenance treatment）
Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication
A：pCR patientsDrug
After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Camrelizumab maintenance treatment）
Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication
B：pCR patientsDrug
After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Best Supportive Care）
Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication
| Study group | Role | What they receive |
|---|---|---|
| After 2 cycles of neoadjuvant therapy,non-pCR patients adjuvant treatment | Experimental | After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（2-4 cycles Camrelizumab+Albumin Paclitaxel +Cisplatin and Camrelizumab maintenance treatment） Receives: Drug: A：non-pCR patients |
| non-pCR patients adjuvant treatment | Active comparator | After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（Camrelizumab maintenance treatment） Receives: Drug: B：non-pCR patients |
| pCR patients adjuvant treatment | Experimental | After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Camrelizumab maintenance treatment） Receives: Drug: A：pCR patients |
| pCR patients adjuvant treatment(BSC) | Active comparator | After 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Best Supportive Care） Receives: Drug: B：pCR patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response，pCR
defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory
Measured: At time of surgery
3 years disease free survival, DFS
Time after R0 resection to disease recurrence or death
Measured: up to 3 year
Secondary outcomes (5)
Major pathological response（MPR）
defined as ≤ 10% residual viable tumor at the time of surgical resection, as assessed by central pathology laboratory.
Measured: At time of surgery
Objective Response Rate (ORR)
CR（ complete response）+PR（partial response）
Measured: up to 2 year
Disease-Free Survival (DFS)
Time after R0 resection to disease recurrence or death
Measured: up to 5 year
Overall Survival (OS)
defined as the time from randomization to death from any cause during the course of the study.
Measured: up to 5 year
European Organisation for Research and Treatment of Cancer （EORTC） Multi-trait scaling analyses and face validity refined the module to four scales and six single items (QLQ-OES18).
EORTC QLQ-OES18
Measured: up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start15 Jan 2022
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Zhao, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Song Zhao, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182944
- Sponsor's protocol ID
- L2021-Y346-002
- Status last verified
- Nov 2021
- First submitted
- 21 Dec 2021
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Phase II Study of Perioperative Camrelizumab Combined With Albumin Paclitaxel and Cisplatin in Patients With Resectable Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05182944
- Acronym / sponsor ID
- L2021-Y346-002
- Conditions
- Esophageal Cancer
- Keywords
- ESCC, perioperative, immune checkpoint inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 10 Jan 2022 (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.
The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
Detailed description
The incidence of esophageal cancer is ranked seventh in the world, and the mortality rate ranks sixth in the world. Surgical treatment of early esophageal cancer has a good prognosis, and advanced esophageal cancer often requires a combination of surgery, chemotherapy, radiotherapy and immunotherapy, but the prognosis is still poor. The investigators designed a randomized, controlled, phase II study of perioperative camrelizumab combined with albumin paclitaxel and cisplatin in patients with resectable esophageal squamous cell carcinoma. The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| After 2 cycles of neoadjuvant therapy,non-pCR patients adjuvant treatment | Experimental | Drug: A：non-pCR patientsAfter 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（2-4 cycles Camrelizumab+Albumin Paclitaxel +Cisplatin and Camrelizumab maintenance treatment） |
| non-pCR patients adjuvant treatment | Active comparator | Drug: B：non-pCR patientsAfter 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（Camrelizumab maintenance treatment） |
| pCR patients adjuvant treatment | Experimental | Drug: A：pCR patientsAfter 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Camrelizumab maintenance treatment） |
| pCR patients adjuvant treatment(BSC) | Active comparator | Drug: B：pCR patientsAfter 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Best Supportive Care） |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18-80 years, males or females；
- Histologically or cytologically confirmed as ESCC；
- Esophageal squamous cell carcinoma without anti-tumor treatment, and the clinical stage is T1b-2N+M0 or T3-4aN+/-M0 (AJCC/UICC TNM staging system 8th edition);
- It can provide tumor tissue for the detection of PD-L1 expression level;
- Follow-up surgery plan: radical esophageal squamous cell carcinoma surgery with esophagogastric reconstruction combined with at least complete 2 field lymph node dissection;
Key exclusion criteria (20 listed)
- Cervical esophageal squamous cell carcinoma;
- Combined with cervical, supraclavicular, abdominal, retroperitoneal and pelvic lymph node metastasis (except pericardial lymph node metastasis and left gastric lymph node metastasis);
- Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ；
- Previously received anti-tumor therapy for the primary disease (including surgery, chemotherapy, targeted therapy, immunotherapy, anti-angiogenesis therapy, radiotherapy, radiofrequency ablation, etc.) and other research treatments, except for Chinese patent medicines or Chinese herbal medicines stopped for more than 7 days ；
- Previously active, potentially relapsed or undiagnosed autoimmune diseases, skin diseases (vitiligo, psoriasis, alopecia) without systemic treatment, well controlled type I diabetes, hypothyroidism (only thyroid hormone replacement therapy), and other diseases that were not expected to relapse under external stimulation were included.
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 |
|---|---|---|
| A：non-pCR patientsAfter 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（2-4 cycles Camrelizumab+Albumin Paclitaxel+Cisplatin and Camrelizumab maintenance treatment） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication | Drug | After 2 cycles of neoadjuvant therapy,non-pCR patients adjuvant treatment |
| B：non-pCR patientsAfter 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, non-pCR patients adjuvant treatment（Camrelizumab maintenance treatment） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication | Drug | non-pCR patients adjuvant treatment |
| A：pCR patientsAfter 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Camrelizumab maintenance treatment） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication | Drug | pCR patients adjuvant treatment |
| B：pCR patientsAfter 2 cycles of neoadjuvant therapy（Camrelizumab+Albumin Paclitaxel+Cisplatin）, pCR patients adjuvant treatment（Best Supportive Care） Camrelizumab, 200 mg，Intravenous injection，q3W continuous medication Albumin Paclitaxel, 125 mg/m2, Intravenous injection d1,8 q3W continuous medication Cisplatin: 75mg/m2, Intravenous injection,d1, q3W continuous medication | Drug | pCR patients adjuvant treatment(BSC) |
Primary outcome
Pathologic complete response，pCR
Time frame: At time of surgery
defined as the absence of any viable tumor at the time of surgical resection, as assessed by central and local pathology laboratory
3 years disease free survival, DFS
Time frame: up to 3 year
Time after R0 resection to disease recurrence or death
5 secondary outcomes
Major pathological response（MPR）
Time frame: At time of surgery
Objective Response Rate (ORR)
Time frame: up to 2 year
Disease-Free Survival (DFS)
Time frame: up to 5 year
Overall Survival (OS)
Time frame: up to 5 year
European Organisation for Research and Treatment of Cancer （EORTC） Multi-trait scaling analyses and face validity refined the module to four scales and six single items (QLQ-OES18).
Time frame: up to 5 year
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 11 May 2022.
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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.
Song Zhao principal investigator
The First Affiliated Hospital of Zhengzhou University
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 A：non-pCR patients, B：non-pCR patients and A：pCR patients in people with Esophageal Cancer, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 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 11 May 2022. 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 Song Zhao (13673665008, zhaosong@zzu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response，pCR (time frame: At time of surgery). The study lists 2 primary outcomes in all. 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 11 May 2022.