Actively Recruiting
Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab as Second-line Treatment in MSS Type Metastatic Colorectal Cancer Based on RAS Gene Status
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-11-28
40
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the objective response rate of AK104 combined with chemotherapy and targeted drugs (cetuximab or bevacizumab) in the second-line treatment of microsatellite stable (MSS) advanced metastatic colorectal cancer. This single-arm, open-label study focuses on patients with metastatic colorectal adenocarcinoma who have previously received first-line therapy based on oxaliplatin. The study is conducted at a single center and aims to assess both the efficacy and safety of this combination treatment. Participants will receive a combination of AK104 with chemotherapy (FOLFIRI) and either cetuximab or bevacizumab as their second-line treatment. The treatment regimen is designed to target the cancer more effectively based on the tumor's RAS gene status. The study involves only one treatment arm where all participants receive this combination therapy. During the study, participants will be monitored through imaging and clinical evaluations to measure tumor response according to RECIST v1.1 criteria. Researchers will collect tumor tissue samples for analysis and assess organ function through blood tests to ensure participants meet safety requirements. The primary outcome is the objective response rate, which measures the proportion of patients experiencing a significant reduction in tumor size. The study includes follow-up for safety and efficacy until the end date, with a total participation age range from 18 to 75 years old.
CONDITIONS
Brief Title
Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign a written informed consent form.
- Age between 18 and 75 years, any gender.
- Eastern Cancer Collaborative Organization (ECOG) physical fitness score of 0 or 1.
- Expected survival of at least 3 months.
- Metastatic colorectal adenocarcinoma confirmed by histology or cytology.
- Microsatellite instability status is MSI-L or MSS type.
- Metastatic lesion is unresectable and unsuitable for curative surgery.
- Previously received only first-line systemic anti-tumor therapy based on oxaliplatin (FOLFOX or CAPOX).
- At least one measurable lesion by RECIST v1.1 criteria.
- Provide 15 recently archived or freshly obtained FFPE tumor tissue sections.
- Good organ function including hematology, kidney, liver, and coagulation parameters as specified.
You will not qualify if you...
- Known MSI-H or dMMR status.
- Presence of BRAF mutations.
- History of other malignant tumors within 3 years except cured local tumors.
- Participation in another clinical study except observational or follow-up studies.
- Previous immunotherapy against tumors including immune checkpoint inhibitors or immune cell therapy.
- Active autoimmune diseases requiring systemic treatment within past 2 years.
- History of inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
- History of immunodeficiency or HIV positive.
- Active pulmonary tuberculosis or syphilis infection.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Current or previous non-infectious pneumonia or interstitial lung disease requiring systemic glucocorticoids.
- Severe infections within 4 weeks prior to treatment.
- Active hepatitis B or C infection above specified viral levels.
- Major surgery or severe trauma within 30 days prior to treatment or planned within 30 days after treatment.
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 - Until disease progression or discontinuation
Participants receive AK104 combined with chemotherapy and either cetuximab or bevacizumab as second-line treatment for metastatic colorectal cancer.
Trial Site Locations
Total: 2 locations
1
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, China
Actively Recruiting
Research Team
X
Xuefeng Fang, Dr
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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