New drug combo aims to outsmart aggressive colon cancer
NCT ID NCT07412613
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 3 trial is testing whether adding the immunotherapy drug AK104 (cadonilimab) before and after surgery can improve outcomes for people with a specific type of colon cancer (MSI-H/dMMR). About 386 participants will be randomly assigned to receive either AK104 plus standard chemotherapy or chemotherapy alone. The main goals are to see if the cancer disappears completely after treatment and if it delays the cancer from coming back.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cadonilimab (AK104), a drug that helps the immune system fight cancer, plus standard chemotherapy drugs (oxaliplatin, capecitabine, 5-fluorouracil, calcium folinate)
- What this could lead to
- If this works, it could offer a more effective treatment option for people with a specific type of colon cancer, potentially reducing the chance of cancer coming back after surgery.
- What could go wrong
- This is an early-phase 3 trial, so results are not yet known. The new drug may not work better than standard chemo, and it could cause side effects like immune-related inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 386 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Mar 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign a written ICF. 2. ≥ 18, ≤ 75 years old at the time of enrollment, regardless of sex. 3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1. 4. Life expectancy greater than 2 years. 5. Histologically confirmed primary colon adenocarcinoma (without squamous carcinoma or sarcomatoid components); colon is defined as ≥ 12cm from the anal verge by colonscopy. 6. Participants with resectable stage IIB-III colon cancer according to the AJCC 8th staging, as assessed by imaging (enhanced CT or enhanced MRI) . 7. 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). 8. 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. 9. 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. 10. 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. Exclusion Criteria: 1. Previously received any anti-tumor treatment for the study disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. 2. 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.). 3. Participated in treatment with investigation drugs or used investigation devices within 4 weeks prior to randomization. 4. History of immunodeficiency; tested positive for HIV antibodies; currently on long-term systemic corticosteroids or other immunosuppressive agents. 5. Known active tuberculosis (TB); subjects suspected of having active TB need clinical examination for exclusion; known active syphilis infection. 6. Known history of allograft organ transplantation or allograft hematopoietic stem cell transplantation. 7. Previous history of pneumonitis/interstitial lung disease requiring systemic corticosteroid treatment or currently having pneumonitis. 8. 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). 9. 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. 10. Pregnant or breastfeeding women. 11. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, China
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