Actively Recruiting
AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer
Led by Akeso · Updated on 2026-03-04
560
Participants Needed
2
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.
CONDITIONS
Official Title
AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 to 75 years
- ECOG status of 0 or 1
- Estimated survival of at least 3 months
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma
- Not candidates for radical surgery or local therapy
- No prior systemic anti-tumor therapy for metastatic or recurrent disease
- Prior neoadjuvant or adjuvant therapy allowed if recurrence/metastases occur 12 months or more after last dose
- At least one measurable tumor lesion according to RECIST v1.1
- Adequate organ function per protocol
- Women of childbearing potential and men with female partners of childbearing potential agree to use effective contraception during and for 180 days after treatment
You will not qualify if you...
- Other malignant tumors within 3 years, except those cured
- Participation in another interventional study within 4 weeks before starting study drugs
- Palliative local treatment for non-target lesions within 2 weeks before starting treatment
- Received non-specific immunomodulatory therapy within 2 weeks before starting treatment
- Uncontrolled combined diseases
- Active clinical infections
- History of severe bleeding or coagulation problems
- Known active tuberculosis or suspected active tuberculosis
- Known active syphilis infection
- Live vaccine received within 30 days before study or planned during study
- Significant gastrointestinal obstruction
- Toxicities from prior anticancer therapy not resolved to Grade 1 or less (NCI-CTCAE v5.0)
- Pregnant or lactating women
- Any condition deemed inappropriate by investigator
- Local or systemic non-malignant diseases or symptoms secondary to tumor causing higher medical risk or uncertain survival
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Sixth Hospital,Sun Yat-sen University
Guanzhou, Guangdong, China, 510000
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guanzhou, Guangdong, China
Actively Recruiting
Research Team
X
Xufang Yu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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