Locally Advanced Rectal CancerNCT06894797
Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX in Rectal Cancer.
A study testing Concurrent Chemoradiotherapy（Radiation + Capecitabine）, irinotecan hydrochloride liposome injection and Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
The Efficacy and Safety of Long-Course Preoperative Chemoradiotherapy Combined with Consolidation or Induction NALIRIFOX Chemotherapy in the Treatment of Locally Advanced Rectal Cancer: A Prospective, Multicenter, Phase II Study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Rectal Cancer
- What is being tested?
- Concurrent Chemoradiotherapy（Radiation + Capecitabine）, irinotecan hydrochloride liposome injection and Oxaliplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Oct 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
- Subjects participate in the study need to sign the informed consent, and demonstrate good compliance.
- Age: 18~75 years old.
- Histopathologically confirmed rectal adenocarcinoma.
- Locally advanced rectal cancer, determined at baseline.
- No prior systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0~1.
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- Expected survival ≥ 12 months.
- Adequate bone marrow function (In the absence of blood transfusion within 14 days, correction with granulocyte colony-stimulating factor or other hematopoietic stimulating factor was not used within 7 days prior to laboratory examination) :
- ①Absolute neutrophil count (ANC) ≥1.5×10^9/L, Platelet count ≥100×10^9/L, Hemoglobin (Hb) ≥9g/dL.
- ② Liver function: Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN, liver metastasis, AST and ALT≤5×ULN.
- ③ Renal function: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min.
- ④International Normalized Ratio (INR) ≤ 1.5 ULN, Prothrombin time and activated partial thromboplastin time (APTT) ≤ 1.5 ULN
- Microsatellite Stability (MSS) or proficient MisMatch Repair (pMMR).
Who cannot join
- Within 4 weeks prior to treatment, subjects must not have received radiotherapy, surgery, chemotherapy, immunotherapy for tumors, molecular targeted therapies, or other investigational drugs.
- microsatellite instability (MSI) or mismatch repair gene deletion (dMMR)
- Distant metastasis
- Significant clinical bleeding symptoms or significant bleeding tendency within 3 months prior to treatment (bleeding > 30ml within 3 months), hematemesis, black stool, blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks), etc. Treatment of venous/venous thrombotic events within the first 6 months, such as cerebrovascular accidents (including transient brain lesions) Ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; Or need to use warfarin or Long-term anticoagulant therapy with heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or chlorine) is required Picogrel ≥75 mg/day).
- During screening, tumors were found to invade large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava that there was a risk of major bleeding by the investigator judged.
- Active heart disease, including myocardial infarction, severe/unstable angina, occurred 6 months before treatment. ultrasonic Left ventricular ejection fraction <50% was detected by cardiogram, indicating poor arrhythmia control.
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- High blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg).
- Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc.
- Known or suspected allergy to the investigational drug or a similar drug.
- Active or uncontrolled severe infection.
- Known human immunodeficiency virus (HIV) infection.
- Any other disease with clinically significant metabolic abnormalities, physical abnormalities, or laboratory abnormalities Often, in the investigator's judgment, there is reason to suspect that the patient has a disease or condition that is not suitable for use of the investigational drug state (such as having a seizure and requiring treatment) that will either affect the interpretation of the study results or make the patient In a high-risk situation.
- Patients who have been co-administered a potent CYP3A4 inducer within 3 weeks prior to first dosing, or a potent CYP3A4 inhibitor or a potent UGT1A1 inhibitor within 3 weeks prior to first dosing
- Inability to comply with study protocols or study procedures.
- Patients who are not suitable to participate in this trial judged by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xicheng Wang, MD contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Yongheng Li, MD, 13810277398, yonghenglee@163.com
Xicheng Wang, MD, 13439563949
About this study
Official title: The Efficacy and Safety of Long-Course Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX Chemotherapy in the Treatment of Locally Advanced Rectal Cancer: A Prospective, Multicenter, Phase II Study.
The Efficacy and Safety of Long-Course Preoperative Chemoradiotherapy Combined with Consolidation or Induction NALIRIFOX Chemotherapy in the Treatment of Locally Advanced Rectal Cancer: A Prospective, Multicenter, Phase II Study.
- Conditions
- Locally Advanced Rectal Cancer
- Being tested
- Concurrent Chemoradiotherapy（Radiation + Capecitabine）, irinotecan hydrochloride liposome injection, Oxaliplatin, 5-FU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent Chemoradiotherapy（Radiation + Capecitabine）Radiation
Capecitabine 825 mg/m^2 Po BlD, Monday-Friday, on days of radiation treatment only, throughout the duration of RT Radiation：45-50Gy/25fractions/5 weeks，5fractions/week
irinotecan hydrochloride liposome injectionDrug
Also called Nal-IRI
Irinotecan hydrochloride liposome injection (50mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
OxaliplatinDrug
Also called OXA
Oxaliplatin (60mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle.
5-FUDrug
Also called fluorouracil
5-FU (2400mg/m^2) will be administered by intravenous infusion on 46h in a 2-week treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy | Experimental | Patients will receive Concurrent Chemoradiotherapy（Radiation + Capecitabine） followed by NALIRIFOX
Concurrent Chemoradiotherapy：5 Weeks in total
NALIRIFOX：8 Weeks in total Receives: Radiation: Concurrent Chemoradiotherapy（Radiation + Capecitabine）; Drug: irinotecan hydrochloride liposome injection; Drug: Oxaliplatin; Drug: 5-FU |
| Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy | Experimental | Patients will receive NALIRIFOX followed by Concurrent Chemoradiotherapy（Radiation + Capecitabine）
Concurrent Chemoradiotherapy：5 Weeks in total
NALIRIFOX：8 Weeks in total Receives: Radiation: Concurrent Chemoradiotherapy（Radiation + Capecitabine）; Drug: irinotecan hydrochloride liposome injection; Drug: Oxaliplatin; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate
To evaluate the efficacy of anti-tumor
Measured: From baseline up to approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (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 CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yongheng Li, Peking University Cancer Hospital & Institute
- Investigators
- Yongheng Li, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894797
- Sponsor's protocol ID
- CSPC-DNY- LARC-BJ01
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 25 Mar 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 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Long-Course Preoperative Chemoradiotherapy Combined With Consolidation or Induction NALIRIFOX Chemotherapy in the Treatment of Locally Advanced Rectal Cancer: A Prospective, Multicenter, Phase II Study.
- ClinicalTrials.gov ID
- NCT06894797
- Acronym / sponsor ID
- CSPC-DNY- LARC-BJ01
- Conditions
- Locally Advanced Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 25 Mar 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 Efficacy and Safety of Long-Course Preoperative Chemoradiotherapy Combined with Consolidation or Induction NALIRIFOX Chemotherapy in the Treatment of Locally Advanced Rectal Cancer: A Prospective, Multicenter, Phase II Study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy | Experimental | Radiation: Concurrent Chemoradiotherapy（Radiation + Capecitabine）, Drug: irinotecan hydrochloride liposome injection, Drug: Oxaliplatin, Drug: 5-FUPatients will receive Concurrent Chemoradiotherapy（Radiation + Capecitabine） followed by NALIRIFOX Concurrent Chemoradiotherapy：5 Weeks in total NALIRIFOX：8 Weeks in total |
| Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy | Experimental | Radiation: Concurrent Chemoradiotherapy（Radiation + Capecitabine）, Drug: irinotecan hydrochloride liposome injection, Drug: Oxaliplatin, Drug: 5-FUPatients will receive NALIRIFOX followed by Concurrent Chemoradiotherapy（Radiation + Capecitabine） Concurrent Chemoradiotherapy：5 Weeks in total NALIRIFOX：8 Weeks in total |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects participate in the study need to sign the informed consent, and demonstrate good compliance.
- Age: 18~75 years old.
- Histopathologically confirmed rectal adenocarcinoma.
- Locally advanced rectal cancer, determined at baseline.
- No prior systemic therapy.
Key exclusion criteria (15 listed)
- Within 4 weeks prior to treatment, subjects must not have received radiotherapy, surgery, chemotherapy, immunotherapy for tumors, molecular targeted therapies, or other investigational drugs.
- microsatellite instability (MSI) or mismatch repair gene deletion (dMMR)
- Distant metastasis
- Significant clinical bleeding symptoms or significant bleeding tendency within 3 months prior to treatment (bleeding > 30ml within 3 months), hematemesis, black stool, blood in the stool), hemoptysis (> 5 mL of fresh blood within 4 weeks), etc. Treatment of venous/venous thrombotic events within the first 6 months, such as cerebrovascular accidents (including transient brain lesions) Ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; Or need to use warfarin or Long-term anticoagulant therapy with heparin, or long-term antiplatelet therapy (aspirin ≥300 mg/day or chlorine) is required Picogrel ≥75 mg/day).
- During screening, tumors were found to invade large vascular structures, such as pulmonary artery, superior vena cava or inferior vena cava that there was a risk of major bleeding by the investigator judged.
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 |
|---|---|---|
| Concurrent Chemoradiotherapy（Radiation + Capecitabine）Capecitabine 825 mg/m^2 Po BlD, Monday-Friday, on days of radiation treatment only, throughout the duration of RT Radiation：45-50Gy/25fractions/5 weeks，5fractions/week | Radiation | Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy, Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy |
| irinotecan hydrochloride liposome injectionAlso: Nal-IRIIrinotecan hydrochloride liposome injection (50mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle. | Drug | Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy, Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy |
| OxaliplatinAlso: OXAOxaliplatin (60mg/m^2) will be administered by intravenous infusion on day 1 in a 2-week treatment cycle. | Drug | Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy, Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy |
| 5-FUAlso: fluorouracil5-FU (2400mg/m^2) will be administered by intravenous infusion on 46h in a 2-week treatment cycle. | Drug | Long-Course Preoperative Chemoradiotherapy Combined with Consolidation NALIRIFOX Chemotherapy, Long-Course Preoperative Chemoradiotherapy Combined with Induction NALIRIFOX Chemotherapy |
Primary outcome
Pathological complete response rate
Time frame: From baseline up to approximately 3 months
To evaluate the efficacy of anti-tumor
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 25 Mar 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.
Xicheng Wang, MD contact
Yongheng Li, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent Chemoradiotherapy（Radiation + Capecitabine）, irinotecan hydrochloride liposome injection and Oxaliplatin in people with Locally Advanced Rectal Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 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?
Contact Yongheng Li, MD (13810277398, yonghenglee@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate (time frame: From baseline up to approximately 3 months). 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 25 Mar 2025.