Actively Recruiting
ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC
Led by Beijing Hospital · Updated on 2024-03-20
60
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
Sponsors
B
Beijing Hospital
Lead Sponsor
B
Bethune Charitable Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a non-profit phase II, open, clinical study of the combination of irinotecan plus cetuximab and envafolimab as a rechallenge regimen, in pre-treated RAS/BRAF wild type metastatic colorectal cancer patients (according to liquid biopsy at baseline). Patients have been treated in front lines with irinotecan and cetuximab and had a clinical benefit (complete or partial response) from both of them, no matter whether they had treated by any PD-1 inhibitor before.
CONDITIONS
Official Title
ICE Study: Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent before any trial-related procedure not part of standard care
- Male or female aged 18 years or older
- Histologically confirmed colorectal adenocarcinoma
- Diagnosis of metastatic disease
- RAS (NRAS and KRAS exon 2,3 and 4) and BRAF wild-type confirmed by liquid biopsy at screening
- Prior front-line treatment with cetuximab or irinotecan resulting in complete or partial response
- At least 2 months since last cetuximab dose before randomization
- Measurable disease according to RECIST v1.1
- ECOG performance status of 0 to 1 at trial entry
- Estimated life expectancy of more than 12 weeks
- Adequate blood counts and hemoglobin level
- Adequate liver function with bilirubin and liver enzymes within defined limits
- Adequate kidney function with creatinine clearance above 30 mL/min
- Use of effective contraception during study and for 2 months after if risk of pregnancy exists
You will not qualify if you...
- Contraindication to cetuximab or envafolimab
- History of other malignancies except treated basal/squamous cell carcinoma or in situ cervical carcinoma
- Pregnancy or breastfeeding
- Participation in another clinical study or experimental drug treatment within 30 days
- Use of immunosuppressive agents unless tapered or at physiologic replacement doses
- Ongoing neurological symptoms from brain metastases treatment
- Prior organ transplantation including stem cell transplantation
- Significant acute or chronic infections including HIV/AIDS
- Active autoimmune diseases that could worsen with immunostimulatory agents
- Known severe hypersensitivity to study drugs or components including monoclonal antibodies
- History of severe allergic reactions or uncontrolled asthma
- History of keratitis or severe dry eye
- Persistent toxicity from prior therapy above Grade 1
- Known alcohol or drug abuse
- Clinically significant active cardiovascular disease
- Severe acute or chronic medical conditions or psychiatric conditions affecting study participation
- Legal incapacity or limited legal capacity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Y
Yingying Huang
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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