Colorectal Cancer Liver Metastases (CRLM)Phase 2APSOCNCT07544784
AK104 Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS CRLM (APSOC)
A Phase 2 study testing AK104 with radiotherapy and Standard of therapy in people with Colorectal Cancer Liver Metastases (CRLM), run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Liver Metastases (CRLM)
- What is being tested?
- AK104 with radiotherapy and Standard of therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2025to 1 Nov 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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;
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- 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 < 1.5 × ULN, ALT and AST < 2.5 × ULN; ALT and AST < 5 × ULN in the presence of liver metastases; Serum Cr ≤ 1 × ULN, creatinine clearance > 50 mL/min (calculated using the Cockcroft-Gault formula); International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; for patients on anticoagulant therapy, PT within the intended therapeutic range is acceptable;
- Voluntary participation in the study, provision of signed informed consent, good compliance, and willingness to comply with follow-up procedures.
Who cannot join
- 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).
- However, patients with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic therapy in the past 2 years, hypothyroidism requiring only thyroid hormone replacement, or type 1 diabetes mellitus requiring only insulin replacement may be enrolled.
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- 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.
- 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 weeks prior to the first dose is permitted; live attenuated influenza vaccines are not permitted.
- 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 C (negative HCV RNA) may be enrolled.
- 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 port or catheter is not considered severe thromboembolism.
- 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 interpretation of study results; and in the opinion of the investigator, render the patient ineligible for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Wenhua Li
Shanghai
Wenhua Li, +86-021-64175590
About this study
Official title: Efficacy of Cadonilimab (AK104) Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS Colorectal Cancer With Liver Metastases: A Prospective, Randomized Controlled, Single-Center Phase II Clinical Trial (APSOC)
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.
- Being tested
- AK104 with radiotherapy, Standard of therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK104 with radiotherapyDrug
AK104 with radiotherapy combined with standard of therapy
Standard of therapyDrug
Standard of therapy including target therapy and chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | standard therapy Receives: Drug: Standard of therapy |
| Experimental group | Experimental | AK104 plus radiotherapy combined with standard therapy Receives: Drug: AK104 with radiotherapy; Drug: Standard of therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate
Measured: up to approximately 2 years
Secondary outcomes (6)
ETS
Early Tumor Shrink of liver metastasis by MRI
Measured: up to approximately 2 years
PFS
Progression free survival
Measured: up to approximately 2 years
OS
overall survival
Measured: up to approximately 2 years
R0 Resection Rate / NED Rate
Metastatic Lesion R0 Resection Rate / NED Rate
Measured: up to approximately 2 years
Safety
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to approximately 2 years
QoL
Quality of life by QLQ-C30 (V3.0)
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start4 Nov 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Liver Metastases (CRLM)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Wenhua, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544784
- Sponsor's protocol ID
- 2025-192-4341
- Acronym
- APSOC
- Status last verified
- Apr 2026
- First submitted
- 1 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Cadonilimab (AK104) Plus Radiotherapy Combined With Standard Therapy Versus Standard Therapy as First-Line Treatment for pMMR/MSS Colorectal Cancer With Liver Metastases: A Prospective, Randomized Controlled, Single-Center Phase II Clinical Trial (APSOC)
- ClinicalTrials.gov ID
- NCT07544784
- Acronym / sponsor ID
- APSOC / 2025-192-4341
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Drug: Standard of therapystandard therapy |
| Experimental group | Experimental | Drug: AK104 with radiotherapy, Drug: Standard of therapyAK104 plus radiotherapy combined with standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK104 with radiotherapyAK104 with radiotherapy combined with standard of therapy | Drug | Experimental group |
| Standard of therapyStandard of therapy including target therapy and chemotherapy | Drug | Control group, Experimental group |
Primary outcome
ORR
Time frame: up to approximately 2 years
Objective Response Rate
6 secondary outcomes
ETS
Time frame: up to approximately 2 years
PFS
Time frame: up to approximately 2 years
OS
Time frame: up to approximately 2 years
R0 Resection Rate / NED Rate
Time frame: up to approximately 2 years
Safety
Time frame: up to approximately 2 years
QoL
Time frame: up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK104 with radiotherapy and Standard of therapy in people with Colorectal Cancer Liver Metastases (CRLM), run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenhua Li (+86-021-64175590, whliiris@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.