Actively Recruiting
AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)
Led by Fudan University · Updated on 2026-04-22
73
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, randomized controlled, single-center phase II clinical study. It aims to compare the efficacy of AK104 plus radiotherapy combined with standard therapy versus standard therapy as first-line treatment for liver metastases from metastatic colorectal cancer.
CONDITIONS
Official Title
AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histological or cytological confirmation of colorectal cancer
- Presence of liver metastases with at least one measurable target lesion and one liver lesion suitable for radiotherapy
- Treatment-naive patients or those with postoperative recurrence without anti-tumor therapy in the past 6 months and at least 6 months since last adjuvant chemotherapy
- ECOG performance status of 0-1
- Expected overall survival of 3 months or more
- Adequate organ function as shown by laboratory tests within 7 days before screening
- Voluntary participation with signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- History of other cancers within 3 years, except cured carcinoma in situ of cervix or basal cell carcinoma of skin
- Symptomatic brain or meningeal metastases unless stable and treated locally for over 2 months
- Gastrointestinal obstruction, bleeding, or perforation
- Prior treatment with certain immune checkpoint or co-stimulatory antibodies
- Active or relapsing autoimmune diseases, except some stable conditions not requiring systemic therapy
- Current lung diseases such as interstitial lung disease or radiation pneumonitis
- Participation in other investigational drug studies within 4 weeks
- Use of immunosuppressive medications within 4 weeks, with exceptions
- Live attenuated vaccine use within 4 weeks before study or planned during study
- Major surgery within 4 weeks before study or expected during study
- History of HIV, immunodeficiency, organ/stem cell transplantation
- Active chronic hepatitis B or C, except stable or cured cases
- Known active tuberculosis
- Recent severe or active infections requiring antibiotics
- Symptomatic heart failure or uncontrolled arrhythmias
- Uncontrolled high blood pressure
- Recent serious arterial thromboembolic events within 6 months
- Recent severe venous thromboembolism within 3 months
- Neurological or psychiatric disorders affecting compliance
- Alcohol dependence or drug abuse within past year
- Pregnant or breastfeeding women, or those without adequate contraception
- Other medical or psychiatric conditions that increase risk or interfere with study participation or results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Wenhua Li
Shanghai, China
Actively Recruiting
Research Team
W
Wenhua Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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