Actively Recruiting
ICE Study: a Clinical Study of the Combination of Irinotecan Plus Cetuximab and Envafolimab as a Rechallenge Regimen in Metastatic Colorectal Cancer
Led by Beijing Hospital · Updated on 2024-03-20
60
Participants Needed
1
Research Sites
25 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
Researchers are evaluating a combination treatment of irinotecan, cetuximab, and envafolimab as a rechallenge regimen in patients with metastatic colorectal cancer who have a specific genetic profile (RAS/BRAF wild type) confirmed by liquid biopsy. This phase II, non-profit, open-label clinical study focuses on patients previously treated with irinotecan and cetuximab who had a clinical benefit from these drugs, regardless of prior treatment with PD-1 inhibitors. Participants will receive irinotecan (150 mg/m2 every two weeks), cetuximab (500 mg/m2 every two weeks), and envafolimab (200 mg every two weeks). Before starting treatment, a blood sample will be taken to confirm the genetic profile, and this testing will be repeated if the disease progresses. Treatment will continue until disease progression, significant clinical decline, or other withdrawal criteria are met, with some patients possibly continuing treatment beyond initial disease progression if certain conditions are met. During the study, patients will undergo evaluations including blood tests to analyze tumor DNA, assessments of disease progression, and monitoring of overall health using standard criteria like RECIST 1.1 and ECOG performance status. The primary outcome measured is progression-free survival up to 36 months, with overall survival also tracked for the same period. Safety and patient condition will be regularly monitored throughout the study duration.
CONDITIONS
Brief 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
- 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 therapy including cetuximab or irinotecan with major response (complete or partial) per RECIST v1.1
- More than 2 months since last cetuximab dose before enrollment
- Measurable disease per RECIST v1.1
- ECOG performance status of 0 or 1 at trial entry
- Estimated life expectancy over 12 weeks
- Adequate blood counts: WBC 65 2.5 x10^9/L, ANC 65 1.5 x10^9/L, lymphocytes 65 0.5 x10^9/L, platelets 65 100 x10^9/L, hemoglobin 65 9 g/dL
- Adequate liver function: bilirubin 64 1.5 x ULN, AST and ALT 64 2.5 x ULN (or 64 5 x ULN if liver metastases)
- Adequate kidney function: creatinine clearance > 30 mL/min
- Use of effective contraception during study and for 2 months after if at risk of pregnancy
You will not qualify if you...
- Contraindications to cetuximab and/or envafolimab
- History of other cancers except treated basal/squamous skin cancer or in situ cervical carcinoma
- Pregnancy or breastfeeding
- Participation in another clinical study or experimental treatment within 30 days
- Use of immunosuppressive agents unless tapered off, with some exceptions
- Ongoing neurological symptoms from brain metastases treatment
- Prior organ transplantation
- Active serious infections or HIV
- Active autoimmune disease that may worsen with immunostimulatory agents
- Severe hypersensitivity to study drugs or components
- Persisting toxicity from prior therapy above grade 1
- History of alcohol or drug abuse
- Active significant cardiovascular disease
- History of severe eye conditions like keratitis
- Other severe acute or chronic medical or psychiatric conditions that increase risk or interfere with study
- Legal incapacity or limited legal capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for blood sample and eligibility confirmation
Duration - Until disease progression or withdrawal from the trial
Participants receive a combination of irinotecan, cetuximab, and envafolimab as a rechallenge regimen until disease progression or withdrawal criteria are met.
Visits every 2 weeks for drug administration and assessments
Trial Site Locations
Total: 1 location
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
Y
Yingying Huang
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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