AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Trea… (NCT07544784) | Clinical Trial Compass
RecruitingPhase 2
AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)
China73 participantsStarted 2025-11-04
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years, with no gender restriction;
. Histologically or cytologically confirmed colorectal cancer;
. Presence of liver metastases, with at least one measurable target lesion (per RECIST 1.1 criteria) in addition to a single liver metastatic lesion amenable to radiotherapy; patients with initially resectable colorectal cancer liver metastases are excluded;
. Treatment-naive patients; or patients with postoperative recurrence who have not received any anti-tumor therapy within 6 months and at least 6 months have elapsed since the last adjuvant chemotherapy;
. ECOG performance status score of 0-1;
. Expected overall survival ≥ 3 months;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Adequate organ function and reserve, meeting the following laboratory criteria within 7 days prior to screening (inclusive):
. Voluntary participation in the study, provision of signed informed consent, good compliance, and willingness to comply with follow-up procedures.
Exclusion criteria
. History of other malignancy within 3 years prior to enrollment, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
. Symptomatic brain or meningeal metastases, except those treated locally and stable for more than 2 months without symptoms.
. Presence of gastrointestinal obstruction, gastrointestinal bleeding (≥+++ fecal occult blood), or perforation.
. Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, CD137, or CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulatory or checkpoint pathways.
. Subjects with active autoimmune disease or a history of autoimmune disease that may relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis, etc.), or patients at high risk (e.g., organ transplant recipients requiring immunosuppressive therapy).
. Current interstitial lung disease or pneumonitis, pulmonary fibrosis, acute pulmonary disease, or radiation pneumonitis.
. Participation in another investigational drug study within 4 weeks prior to the first dose (based on receipt of investigational product), unless participation was in an observational (non-interventional) study.
. Use of immunosuppressive medications within 4 weeks prior to the first study treatment, excluding topical, nasal, inhaled, or other local corticosteroids; physiological doses of systemic corticosteroids (i.e., ≤10 mg/day prednisone or equivalent); or short-term (≤7 days) corticosteroids for prophylaxis or treatment of non-autoimmune allergic conditions.