Resectable Colon CancerPhase 3NCT07412613
Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
A Phase 3 study testing Cadonilimab (AK104), Oxaliplatin and Capecitabine in people with Resectable Colon Cancer and MSI-H/dMMR Colorectal Cancer, run by Akeso at 1 site in China.
Trial summary
This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resectable Colon Cancer, MSI-H/dMMR Colorectal Cancer
- What is being tested?
- Cadonilimab (AK104), Oxaliplatin and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2026to 15 Mar 2031
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily sign a written ICF.
- ≥ 18, ≤ 75 years old at the time of enrollment, regardless of sex.
- Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1.
- Life expectancy greater than 2 years.
- Histologically confirmed primary colon adenocarcinoma (without squamous carcinoma or sarcomatoid components); colon is defined as ≥ 12cm from the anal verge by colonscopy.
- Participants with resectable stage IIB-III colon cancer according to the AJCC 8th staging, as assessed by imaging (enhanced CT or enhanced MRI) .
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- Microsatellite instability detection demostrates MSI-H (with 5 NCI-recommended microsatellite detection sites: BAT25, BAT26, D5S346, D2S123, D17S250, or combinations of other guidelines and clinically recognized site) , or mismatch repair detection demostrates dMMR (evaluating the expression of 4 MMR proteins: MLH1, MSH2, MSH6, PMS2 by immunohistochemistry, and positive expression is localized to the nucleus).
- Before enrollment, the participant needs to be evaluated by the responsible surgeon to confirm whether he/she is eligible for radical R0 resection, and does not require combined organ resection based on medical history.
- Female participants of childbearing potential must have a urine or serum pregnancy test within 3 days before the first dose (if the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required, and the serum pregnancy result shall prevail), and the result is negative. If a female participant of childbearing potential has sex with a male partner who is not sterilized, the participant must use an acceptable method of contraception from screening and must agree to use a contraceptive method continuously until 120 days after the last dose of study drug; Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point.
- If a non-sterilized male participant has sex with a female partner of childbearing potential, the participant must take an effective method of contraception from the beginning of screening until 120 days after the last dose; Contraception should be discussed with the investigator as to whether to discontinue contraception after this time point.
Who cannot join
- Previously received any anti-tumor treatment for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- Previously (within 3 years) or currently suffering from other malignant tumors, except for cured local tumors (such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, etc.).
- Participated in treatment with investigation drugs or used investigation devices within 4 weeks prior to randomization.
- History of immunodeficiency; tested positive for HIV antibodies; currently on long-term systemic corticosteroids or other immunosuppressive agents.
- Known active tuberculosis (TB); subjects suspected of having active TB need clinical examination for exclusion; known active syphilis infection.
- Known history of allograft organ transplantation or allograft hematopoietic stem cell transplantation.
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- Previous history of pneumonitis/interstitial lung disease requiring systemic corticosteroid treatment or currently having pneumonitis.
- Experiencing severe infection within 4 weeks prior to randomization, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; having received systemic anti-infection treatment for active infection within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or hepatitis C).
- Subjects with active hepatitis B (HBsAg positive and HBV-DNA over 1000 copies/ml (200 IU/ml) or above the lower limit of detection, whichever is higher). Note: Subjects with hepatitis B are required to receive antiviral treatment throughout the study.
- Pregnant or breastfeeding women.
- Previously or currently having any disease, treatment, or abnormal laboratory test results that could confound study results, affect full participation in the study, or make participation not in the best interest of the participant.
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
Sun Yat-sen University Cancer Center
Guangzhou
Ruihua Xu, PhD, 020-87343468, xurh@sysucc.org.cn
About this study
Official title: A Randomized, Open-label, Controlled, Multicenter Phase 3 Clinical Trial of AK104 for Neoadjuvant/Adjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant/adjuvant treatment of AK104 (Cadonilimab) versus adjuvant chemotherapy in patients with resectable MSI-H/dMMR colon cancer.
- Being tested
- Cadonilimab (AK104), Oxaliplatin, Capecitabine, 5- Fluorouracil, Calcium Folinate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadonilimab (AK104)Drug
Anti-PD-1/CTLA-4 tetrameric bispecific antibody
OxaliplatinDrug
Intravenous
CapecitabineDrug
Oral
5- FluorouracilDrug
Intravenous
Calcium FolinateDrug
Intravenous
| Study group | Role | What they receive |
|---|---|---|
| AK104 | Experimental | Participants will receive AK104 before and after surgery Receives: Drug: Cadonilimab (AK104) |
| Physician's choice of chemotherapy | Active comparator | Participants will receive physician's choice of chemotherapy after surgery Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: 5- Fluorouracil; Drug: Calcium Folinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response (pCR) rate as assessed by investigator
Proportion of participants with post-surgery stage of ypT0N0 as assessed by investigator
Measured: 1 month after surgery
Event Free Survival (EFS)
Time from randomization to disease progression, local or distant recurrence in post-surgery phase, or death due to any cause
Measured: Up to approximately 5 years
Secondary outcomes (5)
Overall Survival (OS)
Time from randomization to death from any cause
Measured: Up to approximately 5 years
R0 resection rate
Proportion of R0 resection in participant receiving tumor surgery
Measured: Up to approximately 2 years
Adverse event
Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory findings
Measured: Up to approximately 5 years
Pharmacokinetics (PK)
Serum concentrations of AK104 (Cadonilimab) at different point of time after AK104 administration
Measured: Up to approximately 2 years
Anti-Drug Antibodies(ADAs)
Number and proportion of participants with detectable ADA.
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 posted17 Feb 2026
- Study start15 Apr 2026
- Primary completion15 Jun 2030 (estimated)
- Study completion15 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Colon CancerStudies of the same condition, open and under way.
- More trials run by AkesoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 386 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412613
- Sponsor's protocol ID
- AK104-313
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- A Randomized, Open-label, Controlled, Multicenter Phase 3 Clinical Trial of AK104 for Neoadjuvant/Adjuvant Treatment of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
- ClinicalTrials.gov ID
- NCT07412613
- Acronym / sponsor ID
- AK104-313
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 386 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Jun 2030 (estimated)
- Study completion
- 15 Mar 2031 (estimated)
- First posted
- 17 Feb 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 randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant/adjuvant treatment of AK104 (Cadonilimab) versus adjuvant chemotherapy in patients with resectable MSI-H/dMMR colon cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK104 | Experimental | Drug: Cadonilimab (AK104)Participants will receive AK104 before and after surgery |
| Physician's choice of chemotherapy | Active comparator | Drug: Oxaliplatin, Drug: Capecitabine, Drug: 5- Fluorouracil, Drug: Calcium FolinateParticipants will receive physician's choice of chemotherapy after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily sign a written ICF.
- ≥ 18, ≤ 75 years old at the time of enrollment, regardless of sex.
- Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1.
- Life expectancy greater than 2 years.
- Histologically confirmed primary colon adenocarcinoma (without squamous carcinoma or sarcomatoid components); colon is defined as ≥ 12cm from the anal verge by colonscopy.
Key exclusion criteria (11 listed)
- Previously received any anti-tumor treatment for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.
- Previously (within 3 years) or currently suffering from other malignant tumors, except for cured local tumors (such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, etc.).
- Participated in treatment with investigation drugs or used investigation devices within 4 weeks prior to randomization.
- History of immunodeficiency; tested positive for HIV antibodies; currently on long-term systemic corticosteroids or other immunosuppressive agents.
- Known active tuberculosis (TB); subjects suspected of having active TB need clinical examination for exclusion; known active syphilis infection.
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 |
|---|---|---|
| Cadonilimab (AK104)Anti-PD-1/CTLA-4 tetrameric bispecific antibody | Drug | AK104 |
| OxaliplatinIntravenous | Drug | Physician's choice of chemotherapy |
| CapecitabineOral | Drug | Physician's choice of chemotherapy |
| 5- FluorouracilIntravenous | Drug | Physician's choice of chemotherapy |
| Calcium FolinateIntravenous | Drug | Physician's choice of chemotherapy |
Primary outcome
Pathologic Complete Response (pCR) rate as assessed by investigator
Time frame: 1 month after surgery
Proportion of participants with post-surgery stage of ypT0N0 as assessed by investigator
Event Free Survival (EFS)
Time frame: Up to approximately 5 years
Time from randomization to disease progression, local or distant recurrence in post-surgery phase, or death due to any cause
5 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 5 years
R0 resection rate
Time frame: Up to approximately 2 years
Adverse event
Time frame: Up to approximately 5 years
Pharmacokinetics (PK)
Time frame: Up to approximately 2 years
Anti-Drug Antibodies(ADAs)
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.
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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.
Ruihua Xu, PhD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cadonilimab (AK104), Oxaliplatin and Capecitabine in people with Resectable Colon Cancer and MSI-H/dMMR Colorectal Cancer, run by Akeso 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 10 inclusion and 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xufang Yu, MD (021-60472800, xufang.yu@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (pCR) rate as assessed by investigator (time frame: 1 month after surgery). The study lists 2 primary outcomes in all. 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.