Actively Recruiting
Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer
Led by Sun Yat-sen University · Updated on 2025-09-26
20
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if Iparomlimab and Tuvonralimab combined with bevacizumab and FOLFIRI (IB-FOLFIRI) is safe and effective in treating adults with BRAF V600E-mutant metastatic colorectal cancer (mCRC). The main questions it aims to answer are: Does IB-FOLFIRI improve clinical outcomes compared with historical outcomes in this population? What is the safety profile of IB-FOLFIRI in patients with BRAF V600E-mutant mCRC? Participants will: Receive Iparomlimab and Tuvonralimab, bevacizumab, and FOLFIRI every two weeks Have blood samples and/or tumor tissue collected for biomarker analysis (e.g., ctDNA sequencing) Undergo regular imaging and clinical evaluations to assess treatment response and safety
CONDITIONS
Official Title
Safety and Efficacy of IB-FOLFIRI in BRAF V600E-Mutant Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically confirmed metastatic colorectal adenocarcinoma
- Confirmed BRAF V600E mutation by tissue pathology or ctDNA testing
- Disease progression after at least one prior treatment with FOLFOX/XELOX ± bevacizumab or FOLFOXIRI ± bevacizumab, with no irinotecan failure and no progression within 3 months after treatment
- Prior first-line treatment with cetuximab plus a BRAF inhibitor allowed
- At least one measurable lesion per RECIST v1.1
- Adequate blood counts and liver function within specified limits
- Adequate renal function (CrCl ≥ 50 mL/min or serum creatinine ≤ 1.5 × ULN)
- Liver function classified as Child-Pugh class A
- ECOG performance status of 0 or 1
- Expected survival greater than 3 months
- Signed informed consent
- Willingness and ability to comply with study follow-up
- Negative pregnancy test within 14 days prior to treatment for women of childbearing potential
- Use of medically accepted contraception during the study and for 3 months after last dose for women of childbearing potential
- Male participants must have surgical sterilization or use effective contraception during the study and for 3 months after last dose
You will not qualify if you...
- Presence of KRAS or NRAS mutations
- MSI-H/dMMR status
- Prior treatment with PD-1, PD-L1, or CTLA-4 inhibitors
- Known contraindications to irinotecan at planned dose
- Use of systemic immunosuppressive drugs within 1 week prior to treatment
- Active or recent autoimmune disease within past 2 years
- Known primary immunodeficiency
- History of allogeneic organ or hematopoietic stem cell transplantation
- Retinal vein occlusion or risk factors such as uncontrolled glaucoma
- History of acute or chronic pancreatitis
- Chronic inflammatory bowel disease or Crohn's disease requiring treatment within 12 months
- Gastrointestinal disorders affecting drug absorption
- Neuromuscular diseases with elevated creatine kinase
- Residual grade 2 or higher toxicity from prior therapy (except alopecia or neuropathy)
- History of HIV infection
- History of Gilbert's syndrome
- Interstitial pneumonia or extensive symptomatic pulmonary fibrosis
- Severe uncontrolled comorbidities including cardiovascular events within 6 months
- Uncontrolled hypertension or unstable angina
- Congestive heart failure NYHA class 2-4
- Cardiac arrhythmias requiring treatment
- Central nervous system diseases including brain tumors, uncontrolled epilepsy, brain metastases, or stroke history
- Other uncontrolled medical or psychiatric conditions
- Other malignancies within past 5 years except certain curatively treated cancers
- Allergy to any study drug
- Pregnant or breastfeeding women
- Women of childbearing potential or men refusing effective contraception
- Inability or unwillingness to comply with study protocol
- Any disease or condition posing high risk or contraindication to study drug use
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
D
Deshen Wang, PhD
CONTACT
R
Ruihua Xu, PhD
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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