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Compares treatment options for Colorectal Cancer Liver Metastases (CRLM)
Official title AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)
ClinicalTrials.gov ID: NCT07544784
What this study is testing
What is AK104 with radiotherapy?
AK104 with radiotherapy is an investigational medicine, being studied as a potential treatment for colorectal cancer liver metastases (crlm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Treatment-naive patients; or patients with postoperative recurrence who have not received any anti-tumor therapy within 6 months and at least 6...
- ECOG performance status score of 0-1;
You likely can't join if
- 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...
- people with active autoimmune disease or a history of autoimmune disease that may relapse (e.g., systemic lupus erythematosus, rheumatoid arthritis...
- Current interstitial lung disease or pneumonitis, pulmonary fibrosis, acute pulmonary disease, or radiation pneumonitis.
See the full eligibility criteria
Who can join
- 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...
- 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): HB ≥ 90 g/dL, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L; BIL \ 50 mL/min (calculated using the...
- Voluntary participation in the study, provision of signed informed consent, good compliance, and willingness to comply with follow-up procedures.
What rules you out
- 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.
- people 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...
- 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-treatment) 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...
- Administration of a live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study period. Note: Administration of inactivated seasonal influenza vaccine by injection within 4...
- Major surgical procedure (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first study treatment, or expectation of requiring major non-study surgery during the study period.
- History of human immunodeficiency virus (HIV) infection (i.e., positive HIV antibody), other acquired or congenital immunodeficiency disorders, organ transplantation, or stem cell transplantation.
- Active chronic hepatitis B or active hepatitis C. Hepatitis B carriers, patients with hepatitis B stabilized by antiviral therapy (HBV DNA ≤ 200 IU/mL or copy number \< 1000 copies/mL), and patients with cured hepatitis...
- Known active tuberculosis.
- Severe infection within 4 weeks prior to the first dose, or active infection requiring oral or intravenous antibiotic therapy within 2 weeks prior to the first dose.
- Symptomatic congestive heart failure (NYHA Class II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
- Uncontrolled arterial hypertension despite standard treatment (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg).
- Any arterial thromboembolic event within 6 months prior to enrollment, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
- History of deep vein thrombosis, pulmonary embolism, or other severe thromboembolism within 3 months prior to enrollment. Catheter-related thrombosis or superficial venous thrombosis associated with an implanted venous...
- Documented history of neurological or psychiatric disorders: e.g., epilepsy, dementia, poor compliance, or presence of peripheral neurological disorders.
- Alcohol dependence or history of drug abuse within the past 1 year.
- Pregnant or lactating women; individuals of childbearing potential without adequate contraception.
- Other acute or chronic medical conditions, psychiatric disorders, or abnormal laboratory values that may: increase the risk associated with study participation or study drug administration; interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.