Actively Recruiting
Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer
Led by Caigang Liu · Updated on 2024-08-22
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) combined with chemotherapy and bevacizumab as first-line treatment for patients with RAS mutated or right sided-metastatic MSS colorectal cancer
CONDITIONS
Official Title
Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent before study procedures.
- Aged 18 to 75 years at time of consent, any gender.
- ECOG physical fitness score of 0 or 1.
- Expected survival of at least 3 months.
- Histopathologically confirmed recurrent or incurable metastatic colorectal adenocarcinoma.
- Genetic testing shows RAS mutation or tumor located in right half of colon.
- No prior systemic treatment for recurrent or metastatic disease.
- At least one measurable tumor lesion per RECIST v1.1 and agreement to provide tumor tissue samples.
- More than 12 months since end of any adjuvant therapy.
- Good organ function including specific blood counts, kidney, liver, coagulation, and thyroid function within defined limits.
- Female participants of childbearing potential must have a negative pregnancy test and agree to effective contraception during and after treatment.
You will not qualify if you...
- Previous treatment with PD-1, PD-L1, or CTLA-4 monoclonal antibodies.
- Tumor tissue showing dMMR or MSI-H.
- Recent palliative local treatment or systemic immunomodulatory therapy within 2 weeks before randomization.
- Current participation in another interventional clinical study.
- Other malignancies within past 3 years except certain non-invasive cancers.
- Active or untreated brain metastases or related conditions unless stable and asymptomatic.
- Symptoms requiring frequent drainage of pleural, pericardial effusions, or ascites.
- Active autoimmune disease requiring systemic treatment within 2 years, except certain stable conditions.
- Significant cardiovascular or cerebrovascular diseases or risk factors within defined recent periods.
- Unresolved toxicity from prior anti-tumor therapy above specified levels.
- Known interstitial lung disease or symptomatic non-infectious pneumonia.
- Active pulmonary tuberculosis.
- Systemic anti-infective therapy within 2 weeks before randomization.
- History of organ transplantation.
- Tumor invasion into major blood vessels.
- Active diverticulitis, abscess, obstruction, unhealed wounds, ulcers, or fractures.
- Clinically significant bleeding or bleeding disorders.
- Major surgery or trauma within 28 days before randomization.
- Known immune deficiency, HIV positive, or active syphilis.
- Systemic immunosuppressive treatment within 14 days before randomization except allowed corticosteroids.
- Active hepatitis B or C infections without treatment.
- Live vaccine within 30 days before randomization or planned during study.
- History of allergic reactions to study drugs or severe antibody hypersensitivity.
- Any condition judged by investigator to threaten safety or study completion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
Research Team
N
Nan Niu, MD
CONTACT
C
Caigang Liu, MD
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