Lymph Node MetastasisNCT06048146
A Prospective, Multicenter Randomized Controlled Study of the Application of Preoperative FOLFOXIRI Chemotherapy Combined With Lateral Lymph Node Dissection in Low- and Medium-lying Rectal Cancer With Lateral Lymph Node Metastasis
A study testing Experimental: FOLFOXIRI and Lateral lymph node dissection and Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection in people with Lymph Node Metastasis and Cancer of Rectum and Anus, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The goal of this clinical trial is to compare in newly diagnosed patients with resectable rectal cancer with lateral lymph node metastasis. This study aims to further verify the safety and efficacy of FOLFOXIRI three-drug regimen Using multiple omics techniques to identify and confirm specific molecular markers… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lymph Node Metastasis, Cancer of Rectum and Anus, Oxaliplatin
- What is being tested?
- Experimental: FOLFOXIRI and Lateral lymph node dissection and Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Dec 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old, gender is not limited;
- The clinical stage based on magnetic resonance imaging (MRI) is cT1-4aN+M0 (according to AJCC Cancer Staging Manual, 8th Edition, 2018).
- Meet the criteria for lateral lymph node metastasis (lymph node short diameter ≥7mm, or lymph node short diameter ≥5cm with uneven internal signals and no chemical shift effect, or irregular boundaries);
- The primary tumor was located in the rectum (hard tube proctoscopy indicated that the lower margin of the lesion was less than 10cm from the anus);
- Kastler score ≥70, ECOG score 0 or 1;
- Meet the following laboratory diagnostic indicators: hemoglobin ≥100g/L, white blood cells ≥3.5×109
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- /L, neutrophil ≥1.5×109/L, platelet ≥100×109/L; Creatinine ≤1.5× upper limit of normal (UNL); Urea nitrogen (BUN) ≤1.5 upper limit of normal (UNL) alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤2.5×UNL, alkaline phosphatase (ALP) ≤2.5×UNL, total bilirubin (Tbil) ≤2.5×UNL; Urinary protein (-); Clotting time is normal.
- Patients with primary locally advanced rectal cancer required that they had not received surgery, radiotherapy, chemotherapy or other antitumor therapy from diagnosis to enrollment; No previous pelvic radiation;
- Subjects voluntarily join the study and sign the informed consent.
Who cannot join
- A history of malignancy at other sites, excluding curable non-melanic skin cancer and carcinoma in situ of the cervix;
- Unable to complete MRI;
- Preoperative examination indicated the need for combined organ resection;
- Allergic to 5-Fu and platinum drugs; Inability to swallow oral medications;
- The patient is under thrombolytic or anticoagulant therapy, has bleeding diathesis or coagulation dysfunction, or has occurred in the past year Aneurysm, stroke, transient ischemic attack, arteriovenous malformation;
- After renal history, urine test found proteinuria or clinical renal function was obviously abnormal;
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- History of digestive tract fistula, perforation or severe ulcer;
- Active infection is present; Clinically significant cardiac disease (e.g., uncontrolled hypertension (160/110) mm Hg blood pressure, any history of myocardial infarction, unstable angina), NYHA class Ⅱ congestive heart failure, unstable symptomatic arrhythmias, or class II peripheral vascular disease. Myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment;
- Participating in other clinical trials currently or within 4 weeks prior to enrollment;
- long-term adverse drug history, drug addiction history of mental disorders;
- Other cases where the examiner considers from the registration study that there are good reasons for non-conformity: if there are potential inconsistencies with the clinical protocol.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
Beijing, Beijing Municipality, 100021
About this study
The goal of this clinical trial is to compare in newly diagnosed patients with resectable rectal cancer with lateral lymph node metastasis. This study aims to
- further verify the safety and efficacy of FOLFOXIRI three-drug regimen
- Using multiple omics techniques to identify and confirm specific molecular markers Participants will be treated with FOLFOXIRI three-drug combination regimen. Researchers will compare another group treated with conventional preoperative chemoradiotherapy to see if the experimental group is superior to the control group in terms of 3-year disease free survival, local recurrence rate, lateral lymph node positivity rate, and 5-year overall survival rate.
Read the detailed description
The goal of this clinical trial is to compare in newly diagnosed patients with resectable rectal cancer with lateral lymph node metastasis. The main questions it aims to answer are:
- Evaluate the effectiveness and safety of Forfoxiri combined with lateral lymph node dissection, and optimize the treatment plan for rectal cancer patients with resectable lateral lymph node metastasis.
- Using multiple omics techniques to identify and confirm specific molecular markers for chemotherapy response, lateral lymph node metastasis, and distant metastasis in rectal cancer, in order to achieve the goal of precise treatment of lateral lymph node metastasis Participants will
- receive three cycles of chemotherapy with FOLFOXIRI regimen, and the specific dose was: irinotecan 150mg/m2, d1, Oxaliplatin 85mg/m2, d1, 5-Fu, 2400mg/m2, continuously pumped for 46 hours, repeated for 14 days.
- After 3 cycles of chemotherapy, rectal MRI reexamination was performed, and the efficacy was evaluated using the RECIST method.
- For cCR or cPR, another 2 cycles of chemotherapy will be performed, and CT and rectal MRI evaluations will be performed again after treatment. Radical rectal cancer surgery and LLND were performed 4-6 weeks after the last administration (unilateral or bilateral LLND was determined based on the metastasis of LLN before treatment).
- RECIST evaluates patients with SD, and if MRI evaluates rectal cancer patients without rectal fascia involvement (MRF -), they will undergo two cycles of triple drug combination chemotherapy. After treatment, CT and rectal MRI evaluations will be performed again. Rectal cancer radical surgery+LLND will be performed 4-6 weeks after the last administration.
- If MRF+is unable to complete R0 resection or RECIST evaluation of PD patients, in order to ensure the treatment effect of the patients, preoperative long-term synchronous radiotherapy and chemotherapy should be performed. Preoperative concurrent chemoradiotherapy regimen: Capecitabine (1650mg/m2/day, twice orally); Radiotherapy (pelvic cavity 2 Gy/dose, GT50 Gy); Intensity modulated radiation therapy is used for radiotherapy. CT and rectal MRI evaluations are performed again 8-12 weeks after radiotherapy, followed by rectal cancer radical surgery and LLND. If distant metastasis occurs during treatment, a second-line chemotherapy regimen can be chosen.
Researchers will compare another group (Capecitabine (1650mg/m2/day, oral administration twice) was used for long-term concurrent chemoradiotherapy before operation in all patients; Radiotherapy (pelvic cavity 2 Gy/dose, GT50 Gy). Intensity modulated radiation therapy is used for radiotherapy. CT and rectal MRI evaluation are performed again 8-12 weeks after radiotherapy, followed by rectal cancer radical surgery+LLND (unilateral or bilateral LLND is determined based on the LLN metastasis before treatment)) to see if the experimental group is superior to the control group in terms of 3-year disease free survival, local recurrence rate, lateral lymph node positivity rate, and 5-year overall survival rate.
- Conditions
- Lymph Node Metastasis, Cancer of Rectum and Anus, Oxaliplatin, Intestinal Neoplasms, Gastrointestinal Neoplasms, Rectal Diseases
- Being tested
- Experimental: FOLFOXIRI and Lateral lymph node dissection, Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection
- Medical subject headings
- Lymphatic Metastasis, Rectal Neoplasms, Intestinal Neoplasms, Gastrointestinal Neoplasms, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: FOLFOXIRI and Lateral lymph node dissectionDrug
Irinotecan 150mg /m2, d1, oxaliplatin 85mg/m2, d1, 5-Fu, 2400mg/m2, pumped continuously for 46 hours and repeated for 14 days
Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissectionDrug
Radiotherapy was administered five days a week (pelvic 2 Gy/ time, GT50 Gy) for five weeks with capecitabine (1650mg/m2/ day, orally divided into two doses). Intensity modulated radiotherapy (IMRT) was used
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI and Lateral lymph node dissection | Experimental | Participants will
* receive three cycles of chemotherapy with FOLFOXIRI regimen, and the specific dose was: irinotecan 150mg/m2, d1, Oxaliplatin 85mg/m2, d1, 5-Fu, 2400mg/m2, continuously pumped for 46 hours, repeated for 14 days.
* After 3 cycles of chemotherapy, rectal MRI reexamination was performed, and the efficacy was evaluated using the RECIST method.
* For cCR or cPR, another 2 cycles of chemotherapy will be performed, and CT and rectal MRI evaluations will be performed again after treatment. Radical rectal cancer surgery and LLND were performed 4-6 weeks after the last administration (unilateral or bilateral LLND was determined based on the metastasis of LLN before treatment). Receives: Drug: Experimental: FOLFOXIRI and Lateral lymph node dissection; Drug: Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection |
| Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection | Active comparator | All patients received preoperative long-term concurrent chemoradiotherapy: radiotherapy for five weeks, five days a week (pelvic 2 Gy/ time, GT50 Gy), during which capecitabine (1650mg/m2/ day, orally divided twice). Intensity modulated radiotherapy was used. CT and rectal MRI were evaluated again 8-12 weeks after radiotherapy, followed by radical resection of rectal cancer plus LLND (unilateral or bilateral LLND was performed according to LLN metastasis before treatment). Receives: Drug: Experimental: FOLFOXIRI and Lateral lymph node dissection; Drug: Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 year disease free survival
The time between the initiation of a treatment and the recurrence of the disease or death (from any cause)
Measured: From after surgery to three years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Oct 2022
- Primary completion1 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node MetastasisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- jianwei liang, M.D., Principal investigator, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048146
- Sponsor's protocol ID
- LC2022L01
- Status last verified
- Jul 2025
- First submitted
- 15 Sep 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Randomized Controlled Study of the Application of Preoperative FOLFOXIRI Chemotherapy Combined With Lateral Lymph Node Dissection in Low- and Medium-lying Rectal Cancer With Lateral Lymph Node Metastasis
- ClinicalTrials.gov ID
- NCT06048146
- Acronym / sponsor ID
- LC2022L01
- Conditions
- Lymph Node Metastasis, Cancer of Rectum and Anus, Oxaliplatin, Intestinal Neoplasms, Gastrointestinal Neoplasms, Rectal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 21 Sep 2023 (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 compare in newly diagnosed patients with resectable rectal cancer with lateral lymph node metastasis. This study aims to
- further verify the safety and efficacy of FOLFOXIRI three-drug regimen
- Using multiple omics techniques to identify and confirm specific molecular markers Participants will be treated with FOLFOXIRI three-drug combination regimen. Researchers will compare another group treated with conventional preoperative chemoradiotherapy to see if the experimental group is superior to the control group in terms of 3-year disease free survival, local recurrence rate, lateral lymph node positivity rate, and 5-year overall survival rate.
Detailed description
The goal of this clinical trial is to compare in newly diagnosed patients with resectable rectal cancer with lateral lymph node metastasis. The main questions it aims to answer are:
- Evaluate the effectiveness and safety of Forfoxiri combined with lateral lymph node dissection, and optimize the treatment plan for rectal cancer patients with resectable lateral lymph node metastasis.
- Using multiple omics techniques to identify and confirm specific molecular markers for chemotherapy response, lateral lymph node metastasis, and distant metastasis in rectal cancer, in order to achieve the goal of precise treatment of lateral lymph node metastasis Participants will
- receive three cycles of chemotherapy with FOLFOXIRI regimen, and the specific dose was: irinotecan 150mg/m2, d1, Oxaliplatin 85mg/m2, d1, 5-Fu, 2400mg/m2, continuously pumped for 46 hours, repeated for 14 days.
- After 3 cycles of chemotherapy, rectal MRI reexamination was performed, and the efficacy was evaluated using the RECIST method.
- For cCR or cPR, another 2 cycles of chemotherapy will be performed, and CT and rectal MRI evaluations will be performed again after treatment. Radical rectal cancer surgery and LLND were performed 4-6 weeks after the last administration (unilateral or bilateral LLND was determined based on the metastasis of LLN before treatment).
- RECIST evaluates patients with SD, and if MRI evaluates rectal cancer patients without rectal fascia involvement (MRF -), they will undergo two cycles of triple drug combination chemotherapy. After treatment, CT and rectal MRI evaluations will be performed again. Rectal cancer radical surgery+LLND will be performed 4-6 weeks after the last administration.
- If MRF+is unable to complete R0 resection or RECIST evaluation of PD patients, in order to ensure the treatment effect of the patients, preoperative long-term synchronous radiotherapy and chemotherapy should be performed. Preoperative concurrent chemoradiotherapy regimen: Capecitabine (1650mg/m2/day, twice orally); Radiotherapy (pelvic cavity 2 Gy/dose, GT50 Gy); Intensity modulated radiation therapy is used for radiotherapy. CT and rectal MRI evaluations are performed again 8-12 weeks after radiotherapy, followed by rectal cancer radical surgery and LLND. If distant metastasis occurs during treatment, a second-line chemotherapy regimen can be chosen.
Researchers will compare another group (Capecitabine (1650mg/m2/day, oral administration twice) was used for long-term concurrent chemoradiotherapy before operation in all patients; Radiotherapy (pelvic cavity 2 Gy/dose, GT50 Gy). Intensity modulated radiation therapy is used for radiotherapy. CT and rectal MRI evaluation are performed again 8-12 weeks after radiotherapy, followed by rectal cancer radical surgery+LLND (unilateral or bilateral LLND is determined based on the LLN metastasis before treatment)) to see if the experimental group is superior to the control group in terms of 3-year disease free survival, local recurrence rate, lateral lymph node positivity rate, and 5-year overall survival rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI and Lateral lymph node dissection | Experimental | Drug: Experimental: FOLFOXIRI and Lateral lymph node dissection, Drug: Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissectionParticipants will * receive three cycles of chemotherapy with FOLFOXIRI regimen, and the specific dose was: irinotecan 150mg/m2, d1, Oxaliplatin 85mg/m2, d1, 5-Fu, 2400mg/m2, continuously pumped for 46 hours, repeated for 14 days. * After 3 cycles of chemotherapy, rectal MRI reexamination was performed, and the efficacy was evaluated using the RECIST method. * For cCR or cPR, another 2 cycles of chemotherapy will be performed, and CT and rectal MRI evaluations will be performed again after treatment. Radical rectal cancer surgery and LLND were performed 4-6 weeks after the last administration (unilateral or bilateral LLND was determined based on the metastasis of LLN before treatment). |
| Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection | Active comparator | Drug: Experimental: FOLFOXIRI and Lateral lymph node dissection, Drug: Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissectionAll patients received preoperative long-term concurrent chemoradiotherapy: radiotherapy for five weeks, five days a week (pelvic 2 Gy/ time, GT50 Gy), during which capecitabine (1650mg/m2/ day, orally divided twice). Intensity modulated radiotherapy was used. CT and rectal MRI were evaluated again 8-12 weeks after radiotherapy, followed by radical resection of rectal cancer plus LLND (unilateral or bilateral LLND was performed according to LLN metastasis before treatment). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18-70 years old, gender is not limited;
- The clinical stage based on magnetic resonance imaging (MRI) is cT1-4aN+M0 (according to AJCC Cancer Staging Manual, 8th Edition, 2018).
- Meet the criteria for lateral lymph node metastasis (lymph node short diameter ≥7mm, or lymph node short diameter ≥5cm with uneven internal signals and no chemical shift effect, or irregular boundaries);
- The primary tumor was located in the rectum (hard tube proctoscopy indicated that the lower margin of the lesion was less than 10cm from the anus);
- Kastler score ≥70, ECOG score 0 or 1;
Key exclusion criteria (11 listed)
- A history of malignancy at other sites, excluding curable non-melanic skin cancer and carcinoma in situ of the cervix;
- Unable to complete MRI;
- Preoperative examination indicated the need for combined organ resection;
- Allergic to 5-Fu and platinum drugs; Inability to swallow oral medications;
- The patient is under thrombolytic or anticoagulant therapy, has bleeding diathesis or coagulation dysfunction, or has occurred in the past year Aneurysm, stroke, transient ischemic attack, arteriovenous malformation;
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 |
|---|---|---|
| Experimental: FOLFOXIRI and Lateral lymph node dissectionIrinotecan 150mg /m2, d1, oxaliplatin 85mg/m2, d1, 5-Fu, 2400mg/m2, pumped continuously for 46 hours and repeated for 14 days | Drug | FOLFOXIRI and Lateral lymph node dissection, Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection |
| Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissectionRadiotherapy was administered five days a week (pelvic 2 Gy/ time, GT50 Gy) for five weeks with capecitabine (1650mg/m2/ day, orally divided into two doses). Intensity modulated radiotherapy (IMRT) was used | Drug | FOLFOXIRI and Lateral lymph node dissection, Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection |
Primary outcome
3 year disease free survival
Time frame: From after surgery to three years after surgery
The time between the initiation of a treatment and the recurrence of the disease or death (from any cause)
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 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jianwei liang, M.D. principal investigator
Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: FOLFOXIRI and Lateral lymph node dissection and Preoperative long-term concurrent chemoradiotherapy and Lateral lymph node dissection in people with Lymph Node Metastasis and Cancer of Rectum and Anus, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 9 inclusion and 11 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
3 year disease free survival (time frame: From after surgery to three years after surgery). 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 6 Apr 2026.