Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy of Locally Advanced Colorectal Cancer
NCT ID: NCT06405139
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2024-05-01
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine
Patients will receive a modified FOLFOXIRI regimen (nanoliposomal irinotecan 60mg/m2, oxaliplatin 85 mg/m2, and capecitabine 800 mg/m2 twice daily, day 1 to 7), repeated every two weeks. The efficacy and resectability were evaluated every four cycles. Patients who had lesions that were radically resectable after evaluation will receive surgery. This medication will be administrated until disease progression or unacceptable toxicity or resectability or up to a maximum of 12 cycles.
Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine
Nanoliposomal irinotecan 60mg/m2; Oxaliplatin 85 mg/m2; Capecitabine 800 mg/m2 twice daily, day 1 to 7; repeated every two weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine
Nanoliposomal irinotecan 60mg/m2; Oxaliplatin 85 mg/m2; Capecitabine 800 mg/m2 twice daily, day 1 to 7; repeated every two weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥18 and ≤70.
3. ECOG physical status score is 0 or 1.
4. Expected survival period ≥ 12 weeks.
5. Patients with histopathological confirmed MSS/pMMR-type adenocarcinoma of the colon and upper rectum which is not amenable to radiotherapy.
6. R0 resection was expected to be achieved by necessarily combined organ resection, or R0 resection cannot be achieved, assessed by CT and/or MRI and multidisciplinary team (MDT) discussion.
7. The clinical stage was cT4N1-2M0 or cT4bN0M0 according to AJCC 8th edition.
9. Patients with intestinal obstruction was relieved by colonic stenting or ostomy.
10. Patients had not received systematic therapy, such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
11. At least one evaluable lesion (according to RECIST v1.1 standard);
12. Adequate organ function according to the following laboratory test values:
1. Hemoglobin value ≥90g/L.
2. White blood cell count ≥3.5\*109/L.
3. Absolute neutrophil count ≥1.5\*109/L.
4. Platelet count ≥100\*109/L.
5. Serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance ≥60ml/min.
6. Total serum bilirubin ≤1.5 upper normal limit (ULN).
7. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 upper limit of normal value (ULN).
13. Women with reproductive potential (\< 2 years after the last menstrual period) and men use effective contraceptive methods until half a year after the last treatment.
Exclusion Criteria
2. Patients who have participated in other clinical trials in the past 4 weeks.
3. Previous or concurrent cancer diagnosed within 5 years (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix; the treatment of other malignant tumors has been completed for more than 5 years, and there is no clinical and imaging evidence of recurrence or progression except).
4. dMMR/MSI-H-type colorectal cancer.
5. Symptomatic peripheral neuropathy ≥ grade 2 (CTCAE 5.0).
6. Patients unable to swallow or lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
7. Patients had severe bleeding (CTCAE 5.0 grade ≥3) in the previous 4 weeks.
8. History of abdominal fistula, gastrointestinal perforation, intestinal obstruction, chronic diarrhea, or inflammatory bowel disease including Crohn's disease and ulcerative colitis within 6 months prior to the first study treatment.
9. Patients with interstitial lung disease, except only imaging demonstrated interstitial lung disease without symptoms.
10. Uncontrolled central nervous system metastasis (symptomatic or metastatic sites are midbrain, pons, medulla, or spinal cord) or other central nervous system diseases.
11. Received strong inhibitors or inducers of CYP3A4 and CYP2C8, or strong inhibitors of UGT1A1 in the previous 2 weeks.
12. Uncontrolled hypertension by a single-antihypertensive medication (systolic blood pressure \>140 mmHg or diastolic pressure \>90 mmHg). Patients with severe cardiac dysfunction, such as LVEF\< 50%, CHF≥ grade 2, severe/unstable angina, history of stroke or transient ischemic attack or myocardial infarction in the previous 6 months. Patients with a history of ventricular tachycardia, torsades de pointes, prolonged QTc, complete left bundle branch block, or third-degree atrioventricular conduction block.
13. Abnormal blood coagulation function, bleeding tendency or receiving thrombolysis or anticoagulant therapy.
14. Patients of childbearing potential are unwilling to practice contraception.
15. Patients with active hepatitis B, hepatitis C, syphilis, or human immunodeficiency virus infection.
16. Patients with current active infections require anti-infection treatment within 2 weeks of starting study treatment.
17. History of a definite neurological or mental disorder, including epilepsy and dementia.
18. Patients with any clinically significant disease, metabolic disorders, or laboratory abnormality. The investigator could reasonably consider those patients not suitable for the study, affecting the analysis of the results or putting those patients at high risk.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
LIN YANG
chief physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lin Yang
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCC4610
Identifier Type: -
Identifier Source: org_study_id