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 range18 Years
SexALL
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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;
✓. 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.