Locally Advanced Rectal CarcinomaRESETNCT07038122
Reducing the Resection Range After Neoadjuvant Therapy for Locally Advanced Upper Rectal and Rectosigmoid Junction Cancers
A study testing Laparoscopic resection and Neoadjuvant Therapy in people with Locally Advanced Rectal Carcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn evaluate the safety and efficacy of reduced surgical resection margins in patients with local advanced upper rectal or rectosigmoid junction tumors who met the ycT≤3N0M0 regression following neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Locally Advanced Rectal Carcinoma
- What is being tested?
- Laparoscopic resection and Neoadjuvant Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 874 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 20 Jun 2028
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Histopathologically confirmed adenocarcinoma of the rectum or rectosigmoid junction.
- Clinical stage cT3-4N+M0, with or without positive mesorectal fascia (MRF), with or without extramural vascular invasion (EMVI); Tumor location confirmed by imaging to be above the peritoneal reflection and by endoscopy to be in the upper rectum or rectosigmoid junction.
- For patients with pMMR (proficient Mismatch Repair; immunohistochemistry shows expression of all four proteins: MSH1, MSH2, MSH6, PMS2) or MSS (Microsatellite Stable) status: Tumor downstaged to T≤3N0M0 after neoadjuvant chemotherapy or total neoadjuvant therapy (TNT). Chemotherapy regimens include, but are not limited to, FOLFOX6, CAPOX, or FOLFOXIRI.
- For patients with dMMR (deficient Mismatch Repair; immunohistochemistry shows loss of expression in two or more of MSH1, MSH2, MSH6, PMS2) or MSI-H (Microsatellite Instability-High) status: Tumor downstaged to T≤3N0M0 after immunotherapy.
- Pre-neoadjuvant therapy / Preoperative staging methods: All patients underwent contrast-enhanced CT for staging. Peri-rectal metastatic lymph nodes: defined as nodes with short-axis diameter ≥10 mm or exhibiting CT characteristics typical of metastasis. Preoperative chest, abdominal CT, and pelvic MRI ruling out distant metastasis.
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- No signs of bowel obstruction; OR bowel obstruction that has resolved following proximal diverting colostomy.
- No prior colorectal surgery.
- No prior chemotherapy or radiotherapy.
- No prior treatment with biologic agents (e.g., monoclonal antibodies), immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies), or other investigational drugs.
- Prior endocrine therapy: Allowed.
- Signed informed consent form.
Who cannot join
- History of malignant colorectal tumor(s).
- Requiring emergent surgery (e.g., due to bowel obstruction or intestinal hemorrhage).
- Primary tumor invading adjacent organs/tissues precluding R0 resection.
- Multifocal primary tumors.
- Concurrent diagnosis of other active malignancy.
- Participation in other clinical trials within 4 weeks prior to enrollment or current participation.
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- ASA physical status classification ≥ IV and/or ECOG performance status ≥ 2 (see Appendix for details).
- Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction, or significant comorbidities contraindicating surgery.
- History of severe psychiatric disorders.
- Pregnancy or lactation.
- Uncontrolled preoperative infection.
- Other clinical or laboratory conditions deemed by the investigator to render the patient unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
About this study
Official title: Reducing the Resection Range After Neoadjuvant Therapy for Locally Advanced Upper Rectal and Rectosigmoid Junction Cancers: A Prospective, Multicenter, Randomized Controlled Phase 3 Study
The goal of this clinical trial is to learn evaluate the safety and efficacy of reduced surgical resection margins in patients with local advanced upper rectal or rectosigmoid junction tumors who met the ycT≤3N0M0 regression following neoadjuvant therapy. The main questions it aims to answer are:
Does reduced surgical resection margins (3 cm of distal margin and 5 cm of proximal margin) meet the radical resection criteria, including the rate of negative resection margin, the number of lymph node harvested? How is the surgical safety of reduced surgical resection, including the surgical duration , bleeding, recovery time and postoperative complications? Is reduced surgical margins resection (3 cm of distal margin and 5 cm of proximal margin) inferior to conventional surgical margins resection (5 cm of distal margin and 10 cm of proximal margin) in terms of oncology safety?
Read the detailed description
This study will be a prospective, multicenter, randomized phase III controlled trial conducted in collaboration with Sun Yat-sen University Sixth Affiliated Hospital and multiple domestic colorectal cancer centers. It will involve patients with upper rectal or rectosigmoid junction tumors at a clinical stage of cT3-4N+M0. The trial will compare conventional resection margins (distal 5 cm + proximal 10 cm) with reduced margins (distal 3 cm + proximal 5 cm) in patients who have met the ycT ≤3N0M0 regression criteria following neoadjuvant therapy or total neoadjuvant therapy (TNT). The aim is to evaluate the safety and efficacy of reduced surgical resection margins. The primary research objective is 3-year disease-free survival (DFS). The secondary research objectives includes radical surgery outcomes (R0 resection rate and number of lymph nodes dissected), surgical safety metrics (Operation time, intraoperative blood loss, incidence of anastomotic complications, etc.) and other survival outcomes (1-year disease-free survival and overall survival).
- Conditions
- Locally Advanced Rectal Carcinoma
- Being tested
- Laparoscopic resection, Neoadjuvant Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic resectionProcedure or surgery
Laparoscopic resection of bowel and corresponding mesentery.
Neoadjuvant TherapyOther
Neoadjuvant Therapy aims to downstage the tumor including different chemotherapy, targeted therapy and immunotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Conventional resection margins group | Other | Conventional resection margins: Refers to the surgical resection region including 10 cm bowel proximal to the tumor, 5 cm bowel distal to the tumor, and lymph node dissection in the corresponding mesentery. Receives: Procedure: Laparoscopic resection; Other: Neoadjuvant Therapy |
| Reduced resection margins group | Experimental | Reduced resection margins: Refers to the surgical resection region including 5 cm bowel proximal to the tumor, 3 cm bowel distal to the tumor, and lymph node dissection in the corresponding mesentery. Receives: Procedure: Laparoscopic resection; Other: Neoadjuvant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 years DFS
3 years Disease Free Survival Rate
Measured: 3 year
Secondary outcomes (7)
R0 resection rate
R0 resection rate in participants
Measured: 1 year
Number of lymph node harvested
Number of lymph node harvested in participants
Measured: 1 year
Surgical duration
Operative time in participants
Measured: 1 year
Intraoperative blood loss
Blood loss during the operation
Measured: 1 year
Anastomotic leakage
Post-operative leakage in anastomotic site
Measured: 1 year
1 year DFS
1 year Disease Free Survival Rate
Measured: 1 year
3 years OS
3 years Overall Survival Rate
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Jul 2025
- Primary completion20 Jun 2027 (estimated)
- Study completion20 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal 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
- 874 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Huang, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Jun Huang, PhD., Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038122
- Sponsor's protocol ID
- E2025156
- Acronym
- RESET
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing the Resection Range After Neoadjuvant Therapy for Locally Advanced Upper Rectal and Rectosigmoid Junction Cancers: A Prospective, Multicenter, Randomized Controlled Phase 3 Study
- ClinicalTrials.gov ID
- NCT07038122
- Acronym / sponsor ID
- RESET / E2025156
- Conditions
- Locally Advanced Rectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 874 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 20 Jun 2027 (estimated)
- Study completion
- 20 Jun 2028 (estimated)
- First posted
- 26 Jun 2025 (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 goal of this clinical trial is to learn evaluate the safety and efficacy of reduced surgical resection margins in patients with local advanced upper rectal or rectosigmoid junction tumors who met the ycT≤3N0M0 regression following neoadjuvant therapy. The main questions it aims to answer are:
Does reduced surgical resection margins (3 cm of distal margin and 5 cm of proximal margin) meet the radical resection criteria, including the rate of negative resection margin, the number of lymph node harvested? How is the surgical safety of reduced surgical resection, including the surgical duration , bleeding, recovery time and postoperative complications? Is reduced surgical margins resection (3 cm of distal margin and 5 cm of proximal margin) inferior to conventional surgical margins resection (5 cm of distal margin and 10 cm of proximal margin) in terms of oncology safety?
Detailed description
This study will be a prospective, multicenter, randomized phase III controlled trial conducted in collaboration with Sun Yat-sen University Sixth Affiliated Hospital and multiple domestic colorectal cancer centers. It will involve patients with upper rectal or rectosigmoid junction tumors at a clinical stage of cT3-4N+M0. The trial will compare conventional resection margins (distal 5 cm + proximal 10 cm) with reduced margins (distal 3 cm + proximal 5 cm) in patients who have met the ycT ≤3N0M0 regression criteria following neoadjuvant therapy or total neoadjuvant therapy (TNT). The aim is to evaluate the safety and efficacy of reduced surgical resection margins. The primary research objective is 3-year disease-free survival (DFS). The secondary research objectives includes radical surgery outcomes (R0 resection rate and number of lymph nodes dissected), surgical safety metrics (Operation time, intraoperative blood loss, incidence of anastomotic complications, etc.) and other survival outcomes (1-year disease-free survival and overall survival).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional resection margins group | Other | Procedure: Laparoscopic resection, Other: Neoadjuvant TherapyConventional resection margins: Refers to the surgical resection region including 10 cm bowel proximal to the tumor, 5 cm bowel distal to the tumor, and lymph node dissection in the corresponding mesentery. |
| Reduced resection margins group | Experimental | Procedure: Laparoscopic resection, Other: Neoadjuvant TherapyReduced resection margins: Refers to the surgical resection region including 5 cm bowel proximal to the tumor, 3 cm bowel distal to the tumor, and lymph node dissection in the corresponding mesentery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-80 years.
- Histopathologically confirmed adenocarcinoma of the rectum or rectosigmoid junction.
- Clinical stage cT3-4N+M0, with or without positive mesorectal fascia (MRF), with or without extramural vascular invasion (EMVI); Tumor location confirmed by imaging to be above the peritoneal reflection and by endoscopy to be in the upper rectum or rectosigmoid junction.
- For patients with pMMR (proficient Mismatch Repair; immunohistochemistry shows expression of all four proteins: MSH1, MSH2, MSH6, PMS2) or MSS (Microsatellite Stable) status: Tumor downstaged to T≤3N0M0 after neoadjuvant chemotherapy or total neoadjuvant therapy (TNT). Chemotherapy regimens include, but are not limited to, FOLFOX6, CAPOX, or FOLFOXIRI.
- For patients with dMMR (deficient Mismatch Repair; immunohistochemistry shows loss of expression in two or more of MSH1, MSH2, MSH6, PMS2) or MSI-H (Microsatellite Instability-High) status: Tumor downstaged to T≤3N0M0 after immunotherapy.
Key exclusion criteria (12 listed)
- History of malignant colorectal tumor(s).
- Requiring emergent surgery (e.g., due to bowel obstruction or intestinal hemorrhage).
- Primary tumor invading adjacent organs/tissues precluding R0 resection.
- Multifocal primary tumors.
- Concurrent diagnosis of other active malignancy.
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 |
|---|---|---|
| Laparoscopic resectionLaparoscopic resection of bowel and corresponding mesentery. | Procedure or surgery | Conventional resection margins group, Reduced resection margins group |
| Neoadjuvant TherapyNeoadjuvant Therapy aims to downstage the tumor including different chemotherapy, targeted therapy and immunotherapy. | Other | Conventional resection margins group, Reduced resection margins group |
Primary outcome
3 years DFS
Time frame: 3 year
3 years Disease Free Survival Rate
7 secondary outcomes
R0 resection rate
Time frame: 1 year
Number of lymph node harvested
Time frame: 1 year
Surgical duration
Time frame: 1 year
Intraoperative blood loss
Time frame: 1 year
Anastomotic leakage
Time frame: 1 year
1 year DFS
Time frame: 1 year
3 years OS
Time frame: 3 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 18 Dec 2025.
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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.
Jun Huang, PhD. principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic resection and Neoadjuvant Therapy in people with Locally Advanced Rectal Carcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen 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 12 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. 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?
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?
3 years DFS (time frame: 3 year). 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 18 Dec 2025.