Actively Recruiting
Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy of Locally Advanced Colorectal Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-11-29
36
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neoadjuvant chemotherapy has gained acceptance in treating locally advanced breast cancer, esophageal cancer, gastric cancer, and rectal cancer. However, the role of neoadjuvant chemotherapy for locally advanced colon cancer is still in the exploratory stage. The objective of this study is to explore the efficacy and safety of nanoliposomal irinotecan and oxaliplatin combined with capecitabine as a novel conversion therapy for locally advanced colorectal cancer patients.
CONDITIONS
Official Title
Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy of Locally Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 70 years
- Signed informed consent with good compliance and follow-up
- ECOG physical status score of 0 or 1
- Expected survival of at least 12 weeks
- Histopathologically confirmed MSS/pMMR-type adenocarcinoma of the colon or upper rectum not suitable for radiotherapy
- Clinical stage cT4N1-2M0 or cT4bN0M0 according to AJCC 8th edition
- R0 resection expected by combined organ resection or deemed unachievable, assessed by CT/MRI and MDT discussion
- Multiple primary colorectal cancers allowed if one tumor meets inclusion
- Intestinal obstruction relieved by colonic stenting or ostomy
- No prior systemic therapy such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy
- At least one measurable lesion per RECIST v1.1
- Adequate organ function based on specified laboratory values
- Women of reproductive potential and men must use effective contraception until six months after last treatment
You will not qualify if you...
- Known allergy or hypersensitivity to the study drugs or liposomal products
- Participation in another clinical trial within the last 4 weeks
- Other cancers diagnosed within 5 years except certain skin and cervical cancers
- dMMR/MSI-H-type colorectal cancer
- Symptomatic peripheral neuropathy grade 2 or higher
- Inability to swallow or take oral medication due to gastrointestinal issues
- Severe bleeding within the past 4 weeks
- History of abdominal fistula, gastrointestinal perforation, intestinal obstruction, chronic diarrhea, or inflammatory bowel disease within 6 months
- Symptomatic interstitial lung disease
- Uncontrolled central nervous system metastasis or diseases
- Use of certain strong enzyme inhibitors or inducers within 2 weeks
- Uncontrolled hypertension or serious cardiac conditions
- Abnormal blood clotting or use of anticoagulant therapy
- Unwillingness to practice contraception if of childbearing potential
- Active infections like hepatitis B, hepatitis C, syphilis, or HIV
- Active infections requiring treatment within 2 weeks before study
- History of neurological or mental disorders including epilepsy and dementia
- Other significant diseases or laboratory abnormalities that may increase risk or affect study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
L
Lin Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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