Actively Recruiting
Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study
Led by Sun Yat-sen University · Updated on 2024-08-09
34
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this clinical trial is to evaluate the efficacy and safety of cetuximab combined with PD-1 inhibitor and irinotecan in negative ultraselection RAS/BRAF wild-type refractory right-sided metastatic colorectal cancer.
CONDITIONS
Official Title
Cetuximab, Irinotecan, Toripalimab in RAS/BRAF Wild-type Ultraselected Right-sided Colorectal Cancer Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal adenocarcinoma
- Primary tumor located in the right colon
- Metastatic disease with at least one measurable lesion by RECIST v1.1 criteria
- RAS/BRAF V600E wild-type and negative ultraselected for other mutations (PIK3CA, PTEN, EGFR, HER2, MET, ALK, RET, NTRK1)
- Progressed after prior treatment including bevacizumab, irinotecan, oxaliplatin, and 5-fluorouracil, with progression during or within 3 months after irinotecan
- No prior anti-EGFR or PD-1 antibody treatment
- Normal blood counts (platelets >90×10^9/L; white blood cells >3×10^9/L; neutrophils >1.5×10^9/L)
- Serum bilirubin ≤1.5 times upper limit of normal; transaminases ≤5 times upper limit of normal
- No ascites; normal coagulation; albumin ≥35 g/L
- Liver function Child-Pugh grade A
- Serum creatinine less than upper limit of normal or creatinine clearance >50 ml/min
- ECOG performance status 0-2
- Expected survival >3 months
- Signed informed consent
- Willing and able to follow up until death, study completion, or termination
You will not qualify if you...
- Severe arterial thrombosis or ascites
- Bleeding tendencies or coagulation disorders
- Hypertensive crisis or hypertensive encephalopathy
- Severe uncontrolled systemic complications such as infections or diabetes
- Significant cardiovascular diseases within 6 months (stroke, myocardial infarction, uncontrolled hypertension, unstable angina, congestive heart failure NYHA grade 2-4, arrhythmias needing medication)
- Central nervous system diseases including brain tumors, epilepsy, brain metastasis, or stroke
- Other malignancies within past 5 years except certain skin or cervical cancers
- Use of immunosuppressive drugs within 1 week before treatment except certain steroids
- Steroid-dependent interstitial lung disease
- Active autoimmune diseases requiring treatment or history within past 2 years, with some exceptions
- Primary immunodeficiency
- Active tuberculosis
- History of allogeneic organ or stem cell transplantation
- Investigational drug use within 28 days before study
- Allergy to study drugs
- Pregnant or breastfeeding women
- Women of childbearing potential or men not using effective contraception
- Inability or unwillingness to comply with protocol
- Other diseases or impairments posing high risk or contraindication to study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yuhong Li, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here