Actively Recruiting
A Randomized, Controlled, Multicenter Phase III Study of AK112 Plus Chemotherapy Versus Bevacizumab Plus Chemotherapy in First-line Metastatic Colorectal Cancer
Led by Akeso · Updated on 2026-03-04
560
Participants Needed
2
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of AK112 combined with chemotherapy compared to bevacizumab combined with chemotherapy as a first treatment for patients with metastatic colorectal cancer. This Phase III study aims to see how well these treatments work to control cancer progression and improve patient outcomes. The study is sponsored by Akeso and includes adult patients up to 75 years old with confirmed metastatic colorectal adenocarcinoma. Participants are randomly assigned to one of two treatment groups. One group receives AK112 with a chemotherapy regimen called FOLFOXIRI (including Irinotecan, Oxaliplatin, Leucovorin, and 5-FU) for initial treatment, followed by maintenance therapy with Leucovorin and 5-FU plus AK112. The other group receives bevacizumab with the same chemotherapy combination for initial treatment, followed by maintenance with Leucovorin and 5-FU plus bevacizumab. Treatments are given intravenously every two weeks. Throughout the study, participants will be regularly monitored for cancer progression using imaging and other assessments up to approximately three years. Researchers will measure progression-free survival, overall survival, response rates, duration of response, and disease control rate. The study includes safety monitoring and follow-up visits lasting up to about five years. Participants will have assessments of organ function and other health evaluations to track treatment effects and safety.
CONDITIONS
Brief 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 performance 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 occurred 12 months or more after last dose
- At least one measurable tumor according to RECIST v1.1
- Adequate organ function as defined by the protocol
- Women of childbearing potential and men with partners of childbearing potential must use effective contraception during treatment and for 180 days after last dose
You will not qualify if you...
- Other malignant tumors within the past 3 years, except cured cases
- Participation in other interventional studies within 4 weeks before first study drug
- Palliative local treatment for non-target lesions within 2 weeks before first dose
- Recent non-specific immunomodulatory therapy within 2 weeks before first dose
- Uncontrolled combined diseases
- Active clinical infections
- History of severe bleeding or coagulation disorders
- Known active tuberculosis or active syphilis infection
- Receipt of live vaccines within 30 days before study or planned during study
- Significant gastrointestinal obstruction
- Unresolved toxicities from prior anticancer therapy worse than Grade 1
- Pregnant or lactating women
- Any condition deemed unsuitable by investigator
- Non-malignant diseases or symptoms causing higher medical risk or uncertain survival outcomes
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 3 years
Participants receive AK112 plus chemotherapy or Bevacizumab plus chemotherapy as an induction treatment, followed by maintenance therapy with Leucovorin and 5-FU plus AK112 or Bevacizumab.
Infusions every 2 weeks during induction and maintenance phases
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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