Rectal Neoplasms MalignantNCT02966483
Transanal Versus Laparoscopic Total Mesorectal Excision For Rectal Cancer
A study testing TaTME and LpTME in people with Rectal Neoplasms Malignant and Surgery, run by Sun Yat-sen University at 16 sites in China.
Trial summary
Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior alternative regarding resection quality, and oncological outcomes of patients as compared to open surgery in mangy clinical trails. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Neoplasms Malignant, Surgery
- What is being tested?
- TaTME and LpTME
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,115 participants
- Where
- 16 sitesChina
- Study dates
- Apr 2016to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- histologically proven rectal adenocarcinoma;
- tumor located below the level of peritoneal reflection ;
- diagnosis of rectal cancer amenable to curative surgery;
- no evidence of distant metastases;
- preoperative tumor stage within III;
- no threaten mesorectal fascia (MRF)after neoadjuvant therapy;
Show all 9Show fewer
- no contraindication to laparoscopic surgery;
- without history of other malignancies;
- Written informed consent
Who cannot join
- could not perform sphincter preservation surgery (requiring a Mile's procedure);
- T4b tumor invading adjacent organs;
- T1 tumors that can be locally resected
- should take neoadjuvant therapy but refuse it;
- recurrent cancer;
- concurrent or previous diagnosis of invasive cancer within 5 years;
Show all 13Show fewer
- emergent surgery with intestinal obstruction or perforation;
- history of colorectal surgery;
- fecal incontinence;
- history of inflammatory bowel disease;
- with contraindications to general anaesthesia(ASA class 4 or 5);
- pregnant or breast-feeding;
- history of mental disorder
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100730
Department of Gastrointestinal Surgery, The First Hospital of Jilin University
Changchun, Jilin, 130021
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Department of General Surgery, Daping Hospital, Army Medical university
Chongqing, Chongqing Municipality, 400042
XinQiao Hospital of Army Medical University
Chongqing, 400037
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Nanfang Hospital
Guangzhou, Guangdong, 510559
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
Department of Gastrointestinal Surgery，The Affiliated Nanchong Central Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Department of Gastrointestinal Surgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University,
Shanghai, Shanghai Municipality, 200127
Department of Colorectal Surgery, Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Department of gastrointestinal surgery, the Second People's Hospital of Yibin
Yibin, Sichuan, 644000
The Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524001
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563003
About this study
Official title: Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer (TaLaR): A Multicentre Randomised Clinical Trial
Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior alternative regarding resection quality, and oncological outcomes of patients as compared to open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over open surgery with regard to operative invasiveness, patient's recovery, and wound related complications. Thus, laparoscopic surgery has gained great popularity over the past decades. However, specifically for mid and low rectal cancer, laparoscopic surgery is technically demanding, which sometimes leads to high morbidity and unsatisfactory resection quality, especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so called "down-to-up" alternative, has emerged as a promising solution to these problems in recent years and more and more small studies have proven the feasibility and advantages of this technique, making it become a hot topic among both literature and conferences. However, TaTME is still at early birth, higher-level evidences, either multicentric, or comparative study with conventional surgery is strikingly lacking. Thus the investigators conduct this multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better resection quality and result in non-inferior oncological outcome, as well as short term operative morbidity and mortality.
Read the detailed description
Background:In recent years, transanal mesorectal excision (TaTME) has emerged as a promising surgical alternative for rectal cancer, especially for mid and low rectal cancer. Theoretically, TaTME holds the potential advantage of providing better access to mobilize the distal rectum, and thus could achieve better pathologic outcomes, such as lower involved circumferential margin (CRM) and incomplete resected mesorectum, which could translate into better oncological outcome for the patients in the long term. However, until now, the feasibility and the non-inferiority (compared with laparoscopic total mesorectal excision, LpTME) of this technique has only been validated in studies with limitations of small sample size, retrospective nature.
Study Objective:This study aims to evaluate the TaTME technique compared with conventional laparoscopic rectal surgery, focusing on resection quality, as well as long-term survival results.
Study design This study is a prospective, multi-center, randomized, open-label, parallel group trial. The randomisation ratio of TaTME over LpTME will be 1:1. A central electronic data capture (EDC) system will be utilized for randomization, electronic CRF and data collection. All comparative analyses will be conducted on an "intention to treat" basis.
Sample size: Sample-size calculation of this trial based on 3-year DFS and 5-year OS; but the sample size according to 5-year OS was larger than that based on 3-year DFS. The expected 5-year OS among clinical stage I-III rectal cancer patients treated with laTME was 77·4%. Allowing a difference of 10% as the non-inferiority margin, 910 patients would be required to sufficiently declare taTME noninferior to laTME in 5-year OS based on a log-rank test with an α error of 2·5% (in a two-sided test) and power of 80%. Assuming a dropout rate of 20%, a total of 1114 patients were planned to enroll for this trial.
Study Endpoints:The primary end point of this study is 3-year disease-free survival (DFS) rate and a 5-year overall survival (OS) rate. Secondary endpoints include: 1) resection quality, mainly including circumferential involvement rate, and completeness of mesorectum. Resected specimen was pathologically processed and assessed at each center by trained and qualified pathologists independently.2)short term operative results such as morbidity and mortality, etc.; 3) long term oncological outcome such as local recurrence, and overall survival. Besides, functional outcome and quality of life are also evaluated.
- Conditions
- Rectal Neoplasms Malignant, Surgery
- Being tested
- TaTME, LpTME
- Keywords
- Rectal cancer, Laparoscopic surgery, Total mesorectal excision, Transanal, Multicentre randomised clinical trial
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TaTMEProcedure or surgery
Also called Transanal TME
Transanal Total Mesorectal Excision
LpTMEProcedure or surgery
Also called Laparoscopic TME
Conventional Laparoscopic Total Mesorectal Excision
| Study group | Role | What they receive |
|---|---|---|
| Transanal Total Mesorectal Excision | Experimental | The rectum is mobilized and resected transanally (from bottom to up) according to TME principles, via transanal platform (either rigid or flexible platform).An ideal TaTME is defined as the extraperitoneal portion of the rectum being mobilized from below. Receives: Procedure: TaTME |
| Laparoscopic Total Mesorectal Excision | Active comparator | The traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments. Receives: Procedure: LpTME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease-free survival
Measured: 3 years
Overall survival
Overall survival
Measured: 5 years
Secondary outcomes (9)
Positive circumferential resection margin (CRM)
Involved CRM (tumor cells <1mm)
Measured: 3 years
Overall survival
Overall survival
Measured: 10 years
Mesorectal completeness
The quality of the mesorectum or TME specimen (complete;nearly complete; incomplete)
Measured: 3 years
Number of retrieved lymph nodes
Number of retrieved lymph nodes
Measured: 3 years
Morbidity rate
Morbidity rate
Measured: 1 years
Mortality rate
Mortality rate
Measured: 1 years
Anorectal function outcomes
To evaluate defecating function with Wexner score
Measured: 3 years
Sexual functional outcomes
To evaluate sexual function with IIEF(International Index of Erectile Function) questionnaire
Measured: 3 years
The patient's Quality of life: EORTC QLQ-30 questionnaire
To evaluate quality of life with EORTC QLQ-30 questionnaire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2026
- Study completionSep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Rectal Neoplasms MalignantStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Transanal or Laparoscopic Total Mesorectal Excision treat rectal cancer
- Masking
- None (open label)
- Enrolment
- 1,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, The First Hospital of Jilin University, RenJi Hospital, Shengjing Hospital, The Second People's Hospital of Yibin, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Nanchong Central Hospital, Zunyi Medical College, The First Affiliated Hospital of University of South China, Xinqiao Hospital, Nanfang Hospital, Southern Medical University, First Affiliated Hospital Xi'an Jiaotong University, Ruijin Hospital, Affiliated Hospital of Guangdong Medical University, The Third Xiangya Hospital of Central South University
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Jianping Wang, MD,PHD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966483
- Sponsor's protocol ID
- SYSU-RECTAl-2016
- Status last verified
- Oct 2026
- First submitted
- 8 Nov 2016
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen WH, Kang L, Luo SL, Zhang XW, Huang Y, Liu ZH, Wang JP. Transanal total mesorectal excision assisted by single-port laparoscopic surgery for low rectal cancer. Tech Coloproctol. 2015 Sep;19(9):527-34. doi: 10.1007/s10151-015-1342-1. Epub 2015 Jul 29.
PubMed 26220109Kang L, Chen WH, Luo SL, Luo YX, Liu ZH, Huang MJ, Wang JP. Transanal total mesorectal excision for rectal cancer: a preliminary report. Surg Endosc. 2016 Jun;30(6):2552-62. doi: 10.1007/s00464-015-4521-2. Epub 2015 Aug 27.
PubMed 26310534Zeng Z, Luo S, Zhang H, Wu M, Ma D, Wang Q, Xie M, Xu Q, Ouyang J, Xiao Y, Song Y, Feng B, Xu Q, Wang Y, Zhang Y, Shi L, Ling L, Zhang X, Huang L, Yang Z, Peng J, Wu X, Ren D, Huang M, Lan P, Wang J, Tong W, Ren M, Liu H, Kang L; Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group. Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer: The TaLaR Randomized Clinical Trial. JAMA. 2025 Mar 4;333(9):774-783. doi: 10.1001/jama.2024.24276.
PubMed 39847361Chen M, Ye F, Huang P, Liang Z, Liu H, Zheng X, Li W, Luo S, Kang L, Huang L. Inflammatory stress response after transanal vs laparoscopic total mesorectal excision: a cohort study based on the TaLaR trial. Int J Surg. 2024 Jan 1;110(1):151-158. doi: 10.1097/JS9.0000000000000838.
PubMed 37916926Zeng Z, Luo S, Chen J, Cai Y, Zhang X, Kang L. Comparison of pathological outcomes after transanal versus laparoscopic total mesorectal excision: a prospective study using data from randomized control trial. Surg Endosc. 2020 Sep;34(9):3956-3962. doi: 10.1007/s00464-019-07167-1. Epub 2019 Oct 4.
PubMed 31586244
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transanal Versus Laparoscopic Total Mesorectal Excision For Mid And Low Rectal Cancer (TaLaR): A Multicentre Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02966483
- Acronym / sponsor ID
- SYSU-RECTAl-2016
- Conditions
- Rectal Neoplasms Malignant, Surgery
- Keywords
- Rectal cancer, Laparoscopic surgery, Total mesorectal excision, Transanal, Multicentre randomised clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,115 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, The First Hospital of Jilin University, RenJi Hospital, Shengjing Hospital, The Second People's Hospital of Yibin, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Nanchong Central Hospital, Zunyi Medical College, The First Affiliated Hospital of University of South China, Xinqiao Hospital, Nanfang Hospital, Southern Medical University, First Affiliated Hospital Xi'an Jiaotong University, Ruijin Hospital, Affiliated Hospital of Guangdong Medical University, The Third Xiangya Hospital of Central South University
- Study start
- Apr 2016 (actual)
- Primary completion
- Sep 2026 (actual)
- Study completion
- Sep 2026 (actual)
- First posted
- 17 Nov 2016 (estimated)
- 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.
Laparoscopic surgery for rectal cancer has been successfully proven to be a non-inferior alternative regarding resection quality, and oncological outcomes of patients as compared to open surgery in mangy clinical trails. Moreover, laparoscopic surgery is advantageous over open surgery with regard to operative invasiveness, patient's recovery, and wound related complications. Thus, laparoscopic surgery has gained great popularity over the past decades. However, specifically for mid and low rectal cancer, laparoscopic surgery is technically demanding, which sometimes leads to high morbidity and unsatisfactory resection quality, especially in challenging cases such as bulky mesorectum, enlarged prostate, irradiated pelvis, etc. Under this circumstance, transanal total mesorectal excision (TaTME) , the so called "down-to-up" alternative, has emerged as a promising solution to these problems in recent years and more and more small studies have proven the feasibility and advantages of this technique, making it become a hot topic among both literature and conferences. However, TaTME is still at early birth, higher-level evidences, either multicentric, or comparative study with conventional surgery is strikingly lacking. Thus the investigators conduct this multicentre randomised clinical trial, comparing transanal TME versus laparoscopic TME for mid and low rectal cancer, aiming to prove the hypothesis that TaTME may achieve better resection quality and result in non-inferior oncological outcome, as well as short term operative morbidity and mortality.
Detailed description
Background:In recent years, transanal mesorectal excision (TaTME) has emerged as a promising surgical alternative for rectal cancer, especially for mid and low rectal cancer. Theoretically, TaTME holds the potential advantage of providing better access to mobilize the distal rectum, and thus could achieve better pathologic outcomes, such as lower involved circumferential margin (CRM) and incomplete resected mesorectum, which could translate into better oncological outcome for the patients in the long term. However, until now, the feasibility and the non-inferiority (compared with laparoscopic total mesorectal excision, LpTME) of this technique has only been validated in studies with limitations of small sample size, retrospective nature.
Study Objective:This study aims to evaluate the TaTME technique compared with conventional laparoscopic rectal surgery, focusing on resection quality, as well as long-term survival results.
Study design This study is a prospective, multi-center, randomized, open-label, parallel group trial. The randomisation ratio of TaTME over LpTME will be 1:1. A central electronic data capture (EDC) system will be utilized for randomization, electronic CRF and data collection. All comparative analyses will be conducted on an "intention to treat" basis.
Sample size: Sample-size calculation of this trial based on 3-year DFS and 5-year OS; but the sample size according to 5-year OS was larger than that based on 3-year DFS. The expected 5-year OS among clinical stage I-III rectal cancer patients treated with laTME was 77·4%. Allowing a difference of 10% as the non-inferiority margin, 910 patients would be required to sufficiently declare taTME noninferior to laTME in 5-year OS based on a log-rank test with an α error of 2·5% (in a two-sided test) and power of 80%. Assuming a dropout rate of 20%, a total of 1114 patients were planned to enroll for this trial.
Study Endpoints:The primary end point of this study is 3-year disease-free survival (DFS) rate and a 5-year overall survival (OS) rate. Secondary endpoints include: 1) resection quality, mainly including circumferential involvement rate, and completeness of mesorectum. Resected specimen was pathologically processed and assessed at each center by trained and qualified pathologists independently.2)short term operative results such as morbidity and mortality, etc.; 3) long term oncological outcome such as local recurrence, and overall survival. Besides, functional outcome and quality of life are also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Transanal or Laparoscopic Total Mesorectal Excision treat rectal cancer
| Arm | Type | Receives |
|---|---|---|
| Transanal Total Mesorectal Excision | Experimental | Procedure: TaTMEThe rectum is mobilized and resected transanally (from bottom to up) according to TME principles, via transanal platform (either rigid or flexible platform).An ideal TaTME is defined as the extraperitoneal portion of the rectum being mobilized from below. |
| Laparoscopic Total Mesorectal Excision | Active comparator | Procedure: LpTMEThe traditional laparoscopic TME (LpTME) was performed via standard laparoscopic techniques, including multiple trocars and conventional laparoscopic instruments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically proven rectal adenocarcinoma;
- tumor located below the level of peritoneal reflection ;
- diagnosis of rectal cancer amenable to curative surgery;
- no evidence of distant metastases;
- preoperative tumor stage within III;
Key exclusion criteria (13 listed)
- could not perform sphincter preservation surgery (requiring a Mile's procedure);
- T4b tumor invading adjacent organs;
- T1 tumors that can be locally resected
- should take neoadjuvant therapy but refuse it;
- recurrent cancer;
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 |
|---|---|---|
| TaTMEAlso: Transanal TMETransanal Total Mesorectal Excision | Procedure or surgery | Transanal Total Mesorectal Excision |
| LpTMEAlso: Laparoscopic TMEConventional Laparoscopic Total Mesorectal Excision | Procedure or surgery | Laparoscopic Total Mesorectal Excision |
Primary outcome
Disease-free survival
Time frame: 3 years
Disease-free survival
Overall survival
Time frame: 5 years
Overall survival
9 secondary outcomes
Positive circumferential resection margin (CRM)
Time frame: 3 years
Overall survival
Time frame: 10 years
Mesorectal completeness
Time frame: 3 years
Number of retrieved lymph nodes
Time frame: 3 years
Morbidity rate
Time frame: 1 years
Mortality rate
Time frame: 1 years
Anorectal function outcomes
Time frame: 3 years
Sexual functional outcomes
Time frame: 3 years
The patient's Quality of life: EORTC QLQ-30 questionnaire
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 26220109Chen WH, Kang L, Luo SL, Zhang XW, Huang Y, Liu ZH, Wang JP. Transanal total mesorectal excision assisted by single-port laparoscopic surgery for low rectal cancer. Tech Coloproctol. 2015 Sep;19(9):527-34. doi: 10.1007/s10151-015-1342-1. Epub 2015 Jul 29.
- Background: PubMed 26310534Kang L, Chen WH, Luo SL, Luo YX, Liu ZH, Huang MJ, Wang JP. Transanal total mesorectal excision for rectal cancer: a preliminary report. Surg Endosc. 2016 Jun;30(6):2552-62. doi: 10.1007/s00464-015-4521-2. Epub 2015 Aug 27.
- Derived from this study: PubMed 39847361Zeng Z, Luo S, Zhang H, Wu M, Ma D, Wang Q, Xie M, Xu Q, Ouyang J, Xiao Y, Song Y, Feng B, Xu Q, Wang Y, Zhang Y, Shi L, Ling L, Zhang X, Huang L, Yang Z, Peng J, Wu X, Ren D, Huang M, Lan P, Wang J, Tong W, Ren M, Liu H, Kang L; Chinese Transanal Endoscopic Surgery Collaborative (CTESC) Group. Transanal vs Laparoscopic Total Mesorectal Excision and 3-Year Disease-Free Survival in Rectal Cancer: The TaLaR Randomized Clinical Trial. JAMA. 2025 Mar 4;333(9):774-783. doi: 10.1001/jama.2024.24276.
- Derived from this study: PubMed 37916926Chen M, Ye F, Huang P, Liang Z, Liu H, Zheng X, Li W, Luo S, Kang L, Huang L. Inflammatory stress response after transanal vs laparoscopic total mesorectal excision: a cohort study based on the TaLaR trial. Int J Surg. 2024 Jan 1;110(1):151-158. doi: 10.1097/JS9.0000000000000838.
- Derived from this study: PubMed 31586244Zeng Z, Luo S, Chen J, Cai Y, Zhang X, Kang L. Comparison of pathological outcomes after transanal versus laparoscopic total mesorectal excision: a prospective study using data from randomized control trial. Surg Endosc. 2020 Sep;34(9):3956-3962. doi: 10.1007/s00464-019-07167-1. Epub 2019 Oct 4.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Jianping Wang, MD,PHD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TaTME and LpTME in people with Rectal Neoplasms Malignant and Surgery, run by Sun Yat-sen University at 16 sites 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 9 inclusion and 13 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: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 3 years). 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?
On the ClinicalTrials.gov record for NCT02966483, which also lists 5 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 16 Oct 2026.