Esophageal Squamous Cell CarcinomaNCT05420480
Two-field Versus Three-field Lymph Node Dissection in ESCC After Neoadjuvant Therapy
A study testing Two-Field lymph node dissection and Three-Field lymph node dissection in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Comparison of esophagectomy with Two-field Versus Three-field lymphadenectomy in locally advanced ESCC patients after neoadjuvant therapy 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?
- Two-Field lymph node dissection and Three-Field lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jun 2027
- Phase
- Interventional
- 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
- Squamous cell carcinoma was diagnosed by the pathological type of gastroscopic biopsy;
- The primary tumor is located in the thoracic, and the primary site of esophageal cancer is determined by the location of the esophagus where the upper edge of the mass is located (upper thoracic esophagus: from the entrance of the thoracic cavity, down to the level of the lower edge of the azygos vein arch, 20 cm from the incisors to the endoscopy <25 cm; middle thoracic esophagus: from the lower border of the azygos vein arch, down to the level of the inferior pulmonary vein, 25 cm to 30 cm from the incisors on endoscopy; lower thoracic esophagus: from the level of the inferior pulmonary veins, down to the stomach, internal Endoscopy 30 cm to 40 cm from the incisors);
- According to the above examinations, patients with cII-III stage esophageal squamous cell carcinoma after received neoadjuvant therapy (including neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy, neoadjuvant immunotherapy or neoadjuvant immunotherapy combined with chemotherapy, etc.), preoperative clinical evaluation was performed. Patients with esophageal cancer of clinical stage ycT1b-3N0-1M0 who can undergo surgical resection (enhanced chest and abdomen CT, cervical lymph node ultrasound and other methods to evaluate whether the tumor has obvious external invasion, whether the mediastinal lymph nodes have obvious enlargement, whether there are distant organs metastases or not); if the primary tumor is suspected to be T4b, multiple mediastinal lymph node metastases, or remote metastases, etc., whole-body PET-CT, endoscopic ultrasonography (EUS) (optional) and other tests are performed to further clarify the clinical stage), and there is no large cervical lymph nodes (<0.8 cm in short-axis diameter of lymph nodes by CT or ultrasonography, or <0.65 in short- and long-axis diameters of lymph nodes)
- Age ≥18 years old, ≤75 years old, physical condition score ECOG 0～1, expected survival period ≥12 months;
- No major organ dysfunction, blood routine, lung, liver, kidney and heart functions were basically normal.
- Laboratory test indicators must meet the following requirements:
Show all 11Show fewer
- Blood: white blood cells>4.0×109/L, absolute count of neutrophils (ANC)≥2.0×109/L, platelet count>100×109/L, hemoglobin>90g/L Pulmonary function: FEV1≥1.2L, FEV1%≥50%, and DLCO≥50%; usually in elderly patients (over 60 years old), lung function is assessed by the stair climbing test; Liver function: serum bilirubin less than 1.5 times the maximum normal value; ALT and AST less than 1.5 times the maximum normal value.
- Renal function: Serum creatinine (SCr)≤120µmol/L, creatinine clearance rate (CCr)≥60ml/min;
- Be able to understand the situation of this research and sign the informed consent.
- No gender selection
- No healthy subjects are accepted
Who cannot join
- Enhanced CT of chest and abdomen, ultrasound of cervical lymph nodes, whole body PET-CT (optional) or EBUS (optional), etc.
- The clinical staging was determined by imaging examination as (AJCC/UICC8th Edition) T4b unresectable (can be treated by two judged by a senior thoracic surgeon) [52], multiple lymphadenopathy (estimated lymph node metastasis ≥ 3), multiple sites Patients with enlarged lymph nodes (estimated number of lymph node metastases ≥ 2) or distant metastasis (M1); patients with enlarged lymph nodes Cervical lymph nodes (the short-axis diameter of lymph nodes determined by CT or ultrasonography is > 0.8 cm, or the short and long diameters of lymph nodes are > 0.8 cm.
- 0.65);
- Those who have received or are receiving other chemotherapy, radiotherapy or targeted therapy;
- The pathology of gastroscopy is non-squamous cell carcinoma;
- Have other tumors in the past (except for those who have suffered from cervical carcinoma in situ or local skin basal cell carcinoma and have been cured); Other exclusion criteria.
Show all 20Show fewer
- History of autoimmune diseases;
- recent or current use of hormones or immunosuppressants;
- Received immunotherapy in the past;
- Have a history of severe hypersensitivity to antibody drugs in the past;
- Past or ongoing chronic or recurrent autoimmune disease;
- Interstitial lung disease, pulmonary fibrosis, diverticulitis or systemic ulcerative gastrointestinal inflammation;
- Confirmed history of congestive heart failure; angina pectoris poorly controlled by drug therapy; electrocardiogram (ECG) confirmed of transmural myocardial infarction; uncontrolled hypertension; clinically significant valvular heart disease; or high-risk uncontrolled arrhythmia;
- Severe uncontrolled systemic interstitial diseases, such as active infection or poorly controlled diabetes; abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy;
- Women with positive serum pregnancy test or breastfeeding, and men and women of childbearing age who are unwilling to use adequate contraception during study drug treatment;
- Known immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) activity Sexual infection or known HIV seropositivity; including HBV or HCV surface antigen positivity (RNA);
- Known allergy to any study drug;
- Have a history of organ transplantation (including bone marrow autologous transplantation and peripheral stem cell transplantation);
- Those who have peripheral nervous system disorders or a history of obvious mental disorders and central nervous system disorders;
- Concomitant use of anti-tumor drugs outside the research protocol;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lijie Tan contact
China1 site
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Jun Yin, yin.jun2@zs-hospital.sh.cn
Lijie Tan, tan.lijie@zs-hospital.sh.cn
About this study
Official title: Two-field Versus Three-field Lymph Node Dissection for Esophageal Squamous Cell Carcinoma Patients Without Cervical Lymph Node Metastasis After Neoadjuvant Therapy: A Multi-center, Prospective Randomized Controlled Study
Comparison of esophagectomy with Two-field Versus Three-field lymphadenectomy in locally advanced ESCC patients after neoadjuvant therapy
Read the detailed description
In locally advanced esophageal squamous cell carcinoma patients, neoadjuvant therapy has become a standard therapeutic strategy and been widely administered. Neoadjuvant therapy drastically reduces the metastatic lymph nodes rate as verified in numerous studies including CROSS (Netherlands), JCOG9907/1109 (Japan), NEOCRTEC5010 and CMISG1701 (China) trials, which entails a study to characterize the distribution of lymph node metastasis, and to identify the optimal extent of lymphadenectomy in ESCC patients who received neoadjuvant therapy.
This study aims to clarify whether three-field (cervical-thoracic-abdominal) lymphadenectomy will improve survival over two-field (thoracic-abdominal) lymphadenectomy for ESCC patients after neoadjuvant therapy.
An estimated 323 patients will be enrolled. Eligible patients will undergo right recurrent laryngeal nerve lymph node dissection (106recR), which will be subjected to intra-operative frozen resection pathological evaluation. If 106recR lymph node reports POSITIVE, patients will undergo esophagectomy with Three-Field lymphadenectomy (n=75). If 106recR lymph node reports NEGATIVE, patients will be randomized at 1:1 ratio into two groups: A) Esophagectomy with Two-Field lymphadenectomy (n=124) or B) Esophagectomy with Three-Field lymphadenectomy (n=124). Analyses will be done according to the intention-to-treat principle.
The primary end point is overall survival (OS), calculated from the date of randomization to the date of death from any cause. Secondary end point is Disease-free survival. Other exploratory end points include tumor recurrence pattern, quality of life, peri-operative complications, and the correlation between metastases of 106recR and cervical lymph nodes.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Two-Field lymph node dissection, Three-Field lymph node dissection
- Keywords
- Esophageal Squamous Cell Carcinoma, Esophagectomy, Neoadjuvant therapy
- 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.
Two-Field lymph node dissectionProcedure or surgery
The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, patients will be randomized to two groups at 1:1 ratio and receive esophagectomy with "Two-Field" or "Three-Field" lymph node dissection.
Three-Field lymph node dissectionProcedure or surgery
The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, patients will be randomized to two groups at 1:1 ratio and receive esophagectomy with "Two-Field" or "Three-Field" lymph node dissection.
Three-Field lymph node dissectionProcedure or surgery
The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has metastasis, esophagectomy and "Three-Field" lymph node dissection will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Two-Field lymph node dissection (106recR negative by intra-operative frozen section pathology) | Active comparator | The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, esophagectomy and "Two-Field" lymph node dissection will be performed. Receives: Procedure: Two-Field lymph node dissection |
| Three-Field lymph node dissection (106recR negative by intra-operative frozen section pathology) | Experimental | The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, esophagectomy and "Three-Field" lymph node dissection will be performed. Receives: Procedure: Three-Field lymph node dissection |
| Three-Field lymph node dissection (106recR positive by intra-operative frozen section pathology) | Other | The right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has metastasis, esophagectomy and "Three-Field" lymph node dissection will be performed. Receives: Procedure: Three-Field lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival(OS)
Measured: Up to the date of death of any causes since the date of surgery, up to 36 months
Secondary outcomes (1)
Disease free survival (DFS)
Disease recurrence is defined as locoregional (esophageal bed or anastomotic or regional lymph nodes) or metastatic (supraclavicular lymph nodes or distant organs)
Measured: Up to the date of death of any causes since the date of surgery, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 323 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baoji Central Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Suining Central Hospital, Jieyang People's Hospital, Second Affiliated Hospital of Nantong University, Taixing People's Hospital, Hebei Medical University Fourth Hospital, Suzhou Municipal Hospital, Fujian Provincial Hospital, Jining First People's Hospital, The General Hospital of Western Theater Command, Zhejiang Cancer Hospital, Shanghai Chest Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420480
- Sponsor's protocol ID
- B2022-154
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PubMed 25651787Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-field Versus Three-field Lymph Node Dissection for Esophageal Squamous Cell Carcinoma Patients Without Cervical Lymph Node Metastasis After Neoadjuvant Therapy: A Multi-center, Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05420480
- Acronym / sponsor ID
- B2022-154
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal Squamous Cell Carcinoma, Esophagectomy, Neoadjuvant therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 323 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Baoji Central Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Suining Central Hospital, Jieyang People's Hospital, Second Affiliated Hospital of Nantong University, Taixing People's Hospital, Hebei Medical University Fourth Hospital, Suzhou Municipal Hospital, Fujian Provincial Hospital, Jining First People's Hospital, The General Hospital of Western Theater Command, Zhejiang Cancer Hospital, Shanghai Chest Hospital
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Jun 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.
Comparison of esophagectomy with Two-field Versus Three-field lymphadenectomy in locally advanced ESCC patients after neoadjuvant therapy
Detailed description
In locally advanced esophageal squamous cell carcinoma patients, neoadjuvant therapy has become a standard therapeutic strategy and been widely administered. Neoadjuvant therapy drastically reduces the metastatic lymph nodes rate as verified in numerous studies including CROSS (Netherlands), JCOG9907/1109 (Japan), NEOCRTEC5010 and CMISG1701 (China) trials, which entails a study to characterize the distribution of lymph node metastasis, and to identify the optimal extent of lymphadenectomy in ESCC patients who received neoadjuvant therapy.
This study aims to clarify whether three-field (cervical-thoracic-abdominal) lymphadenectomy will improve survival over two-field (thoracic-abdominal) lymphadenectomy for ESCC patients after neoadjuvant therapy.
An estimated 323 patients will be enrolled. Eligible patients will undergo right recurrent laryngeal nerve lymph node dissection (106recR), which will be subjected to intra-operative frozen resection pathological evaluation. If 106recR lymph node reports POSITIVE, patients will undergo esophagectomy with Three-Field lymphadenectomy (n=75). If 106recR lymph node reports NEGATIVE, patients will be randomized at 1:1 ratio into two groups: A) Esophagectomy with Two-Field lymphadenectomy (n=124) or B) Esophagectomy with Three-Field lymphadenectomy (n=124). Analyses will be done according to the intention-to-treat principle.
The primary end point is overall survival (OS), calculated from the date of randomization to the date of death from any cause. Secondary end point is Disease-free survival. Other exploratory end points include tumor recurrence pattern, quality of life, peri-operative complications, and the correlation between metastases of 106recR and cervical lymph nodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Two-Field lymph node dissection (106recR negative by intra-operative frozen section pathology) | Active comparator | Procedure: Two-Field lymph node dissectionThe right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, esophagectomy and "Two-Field" lymph node dissection will be performed. |
| Three-Field lymph node dissection (106recR negative by intra-operative frozen section pathology) | Experimental | Procedure: Three-Field lymph node dissectionThe right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, esophagectomy and "Three-Field" lymph node dissection will be performed. |
| Three-Field lymph node dissection (106recR positive by intra-operative frozen section pathology) | Other | Procedure: Three-Field lymph node dissectionThe right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has metastasis, esophagectomy and "Three-Field" lymph node dissection will be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Squamous cell carcinoma was diagnosed by the pathological type of gastroscopic biopsy;
- The primary tumor is located in the thoracic, and the primary site of esophageal cancer is determined by the location of the esophagus where the upper edge of the mass is located (upper thoracic esophagus: from the entrance of the thoracic cavity, down to the level of the lower edge of the azygos vein arch, 20 cm from the incisors to the endoscopy <25 cm; middle thoracic esophagus: from the lower border of the azygos vein arch, down to the level of the inferior pulmonary vein, 25 cm to 30 cm from the incisors on endoscopy; lower thoracic esophagus: from the level of the inferior pulmonary veins, down to the stomach, internal Endoscopy 30 cm to 40 cm from the incisors);
- According to the above examinations, patients with cII-III stage esophageal squamous cell carcinoma after received neoadjuvant therapy (including neoadjuvant chemoradiotherapy, neoadjuvant chemotherapy, neoadjuvant immunotherapy or neoadjuvant immunotherapy combined with chemotherapy, etc.), preoperative clinical evaluation was performed. Patients with esophageal cancer of clinical stage ycT1b-3N0-1M0 who can undergo surgical resection (enhanced chest and abdomen CT, cervical lymph node ultrasound and other methods to evaluate whether the tumor has obvious external invasion, whether the mediastinal lymph nodes have obvious enlargement, whether there are distant organs metastases or not); if the primary tumor is suspected to be T4b, multiple mediastinal lymph node metastases, or remote metastases, etc., whole-body PET-CT, endoscopic ultrasonography (EUS) (optional) and other tests are performed to further clarify the clinical stage), and there is no large cervical lymph nodes (<0.8 cm in short-axis diameter of lymph nodes by CT or ultrasonography, or <0.65 in short- and long-axis diameters of lymph nodes)
- Age ≥18 years old, ≤75 years old, physical condition score ECOG 0～1, expected survival period ≥12 months;
- No major organ dysfunction, blood routine, lung, liver, kidney and heart functions were basically normal.
Key exclusion criteria (20 listed)
- Enhanced CT of chest and abdomen, ultrasound of cervical lymph nodes, whole body PET-CT (optional) or EBUS (optional), etc.
- The clinical staging was determined by imaging examination as (AJCC/UICC8th Edition) T4b unresectable (can be treated by two judged by a senior thoracic surgeon) [52], multiple lymphadenopathy (estimated lymph node metastasis ≥ 3), multiple sites Patients with enlarged lymph nodes (estimated number of lymph node metastases ≥ 2) or distant metastasis (M1); patients with enlarged lymph nodes Cervical lymph nodes (the short-axis diameter of lymph nodes determined by CT or ultrasonography is > 0.8 cm, or the short and long diameters of lymph nodes are > 0.8 cm.
- 0.65);
- Those who have received or are receiving other chemotherapy, radiotherapy or targeted therapy;
- The pathology of gastroscopy is non-squamous cell carcinoma;
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 |
|---|---|---|
| Two-Field lymph node dissectionThe right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, patients will be randomized to two groups at 1:1 ratio and receive esophagectomy with "Two-Field" or "Three-Field" lymph node dissection. | Procedure or surgery | Two-Field lymph node dissection (106recR negative by intra-operative frozen section pathology) |
| Three-Field lymph node dissectionThe right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has no metastasis, patients will be randomized to two groups at 1:1 ratio and receive esophagectomy with "Two-Field" or "Three-Field" lymph node dissection. | Procedure or surgery | Three-Field lymph node dissection (106recR negative by intra-operative frozen section pathology) |
| Three-Field lymph node dissectionThe right recurrent laryngeal nerve lymph node (106recR) will be dissected and subjected to the intra-operative frozen section pathology. If the 106recR lymph node has metastasis, esophagectomy and "Three-Field" lymph node dissection will be performed. | Procedure or surgery | Three-Field lymph node dissection (106recR positive by intra-operative frozen section pathology) |
Primary outcome
Overall survival(OS)
Time frame: Up to the date of death of any causes since the date of surgery, up to 36 months
1 secondary outcome
Disease free survival (DFS)
Time frame: Up to the date of death of any causes since the date of surgery, up to 36 months
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 21 Jun 2022.
- Background: PubMed 25651787Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
- Background: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
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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.
Lijie Tan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two-Field lymph node dissection and Three-Field lymph node dissection in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Zhongshan 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 11 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: opening soon, as of the sponsor's last update on 21 Jun 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.
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 Jun Yin (+8613917483128, yin.jun2@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival(OS) (time frame: Up to the date of death of any causes since the date of surgery, up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420480, which also lists 2 linked publications.
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 21 Jun 2022.