Actively Recruiting
Efficacy and Safety of AK104 Combined With Chemotherapy and Cetuximab or Bevacizumab
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-11-28
40
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the objective response rate (ORR) of AK104 combined with chemotherapy and cetuximab or bevacizumab in second-line treatment of MSS type advanced colorectal cancer
CONDITIONS
Official 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.
- Histologically or cytologically confirmed metastatic colorectal adenocarcinoma.
- Microsatellite instability status MSI-L or MSS type.
- Metastatic lesions are unresectable and not suitable for curative surgery.
- Previously received only first-line systemic anti-tumor therapy based on oxaliplatin (FOLFOX or CAPOX).
- At least one measurable lesion according to RECIST v1.1.
- Provide 15 recent or fresh tumor tissue sections.
- Good organ function including: hematology (ANC ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L), kidney function (creatinine clearance ≥ 50 mL/min, urinary protein ≤ 1+ or 24-hour urinary protein < 1.0 g), liver function (bilirubin ≤ 1.5× upper limit of normal or ≤ 3× for Gilbert's disease, AST and ALT ≤ 2.5× or ≤ 5× for liver metastasis, albumin ≥ 28 g/L), and coagulation function (INR within acceptable range).
You will not qualify if you...
- Known MSI-High or deficient mismatch repair (dMMR) status.
- Presence of BRAF mutations.
- 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 checkpoint inhibitors or immune cell therapy.
- Active autoimmune diseases requiring systemic treatment in the past 2 years.
- History of active or previous inflammatory bowel disease.
- History of immunodeficiency or positive HIV test.
- Active pulmonary tuberculosis or syphilis infection.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Previous or current non-infectious pneumonia or interstitial lung disease requiring steroids.
- Severe infections within 4 weeks prior to treatment.
- Active hepatitis B or C infection beyond specified viral load limits.
- Major surgery or severe trauma within 30 days before treatment or planned within 30 days after treatment.
- Minor local surgery within 3 days prior to treatment, excluding certain procedures.
AI-Screening
AI-Powered Screening
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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
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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