Actively Recruiting
Negative Ultraselection of Patients With RAS/BRAF Wild-type Refractory Right-Sided Metastatic Colorectal Cancer Receiving Cetuximab in Combination With Toripalimab and Irinotecan: A Phase II, Single-arm Study
Led by Sun Yat-sen University · Updated on 2024-08-09
34
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining cetuximab with a PD-1 inhibitor (toripalimab) and irinotecan in patients with refractory right-sided metastatic colorectal cancer who have no mutations in RAS or BRAF genes. This study focuses on a group of patients with limited treatment options due to the aggressive nature of right-sided tumors and the lack of established benefits from EGFR inhibitors in this population. The trial aims to provide new insights for this specific cancer subtype. Participants will receive cetuximab (500 mg/m²), toripalimab (3 mg/kg), and irinotecan (150 mg/m²) by intravenous infusion every two weeks. Treatment will continue until there is no clinical benefit, intolerable side effects occur, a new cancer treatment is started, consent is withdrawn, participants are lost to follow-up, death, or other study-specified reasons. This is a single-arm, phase 2 study that monitors participant response to this combination therapy. During the study, researchers will assess tumor response every 8 weeks using standardized criteria for up to 24 months. They will track disease control, duration of response, progression-free survival, overall survival, and any treatment-related side effects for up to 5 years. Participants will undergo regular clinical evaluations, laboratory tests, and imaging to monitor their health and treatment effects. Follow-up will continue until death or study completion, ensuring thorough observation of outcomes and safety.
CONDITIONS
Brief 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 according to RECIST v1.1.
- RAS/BRAF V600E wild-type and negative ultraselected for specific mutations.
- Progressed after treatments 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 hematological function (platelets >90x10^9/L; white blood cells >3x10^9/L; neutrophils >1.5x10^9/L).
- Serum bilirubin ≤1.5 times ULN, transaminases ≤5 times ULN.
- No ascites, normal coagulation, albumin ≥35 g/L.
- Liver function Child-Pugh grade A.
- Serum creatinine less than ULN 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 or study completion.
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 including recent stroke or heart attack, uncontrolled hypertension, unstable angina, congestive heart failure (NYHA grade 2-4), or arrhythmias requiring medication.
- Central nervous system diseases such as brain tumors, epilepsy, brain metastasis, or stroke.
- Other malignancies within the past 5 years except certain skin and cervical cancers.
- Use of immunosuppressive drugs within 1 week before treatment, except specific steroids.
- Steroid-dependent interstitial lung disease.
- Active autoimmune disease requiring treatment or history within 2 years, with some exceptions.
- Primary immunodeficiency.
- Active tuberculosis.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Received investigational drugs within 28 days before the study.
- Allergy to any study drugs.
- Pregnant or breastfeeding women.
- Women of childbearing potential or men not using effective non-hormonal contraception.
- Unable or unwilling to comply with study protocol.
- Other diseases or conditions posing high risk for treatment complications.
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)
Duration - Repeated 14-day cycles until disease progression or discontinuation
Participants receive cetuximab, irinotecan, and toripalimab through intravenous infusions every 2 weeks. Treatment continues until clinical benefit ends, intolerable toxicity occurs, or other specified conditions require stopping.
Infusions every 2 weeks with response assessments after every 4 cycles
Duration - Up to 5 years
Participants are monitored for overall survival and treatment-related adverse events up to 5 years after starting treatment.
Periodic visits to assess survival and safety
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
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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