New combo aims to shrink tough colon cancers before surgery
NCT ID NCT06890624
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether a stronger chemotherapy cocktail (cmFOLFOXIRI) plus an immunotherapy drug (PD-1 inhibitor) works better than standard chemotherapy (mFOLFOX6) when given before surgery for locally advanced colon cancer. About 138 patients with high-risk stage II or III colon cancer will be randomly assigned to one of the two treatments. The main goal is to see if the new combo leads to a higher rate of complete tumor disappearance (pathologic complete response) at the time of surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cmFOLFOXIRI plus PD-1 inhibitor (a combination of chemotherapy drugs and an immunotherapy drug)
- What this could lead to
- If successful, this could lead to a more effective pre-surgery treatment for advanced colon cancer, potentially increasing the chance of complete tumor removal and reducing recurrence.
- What could go wrong
- This is an early phase II trial with only 138 participants, so results may not apply to all patients. The combination therapy may cause more side effects than standard chemotherapy, and it is not yet proven to improve long-term outcomes.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 70 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. Willing and able to provide written informed consent. 2. Histological or cytological documentation of adenocarcinoma of the colon (≥ 12 cm from the anal verge). 3. Determined preoperatively by either spiral or multidetector CT: T4 or N2. 4. Male or female subjects \> 18 years \< 70 of age. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. CT or MRI scans (done within 30 days of registration) of the chest, abdomen and pelvis all without clear evidence of distant metastatic (M1) disease. 7. No clinically significant obstruction, perforation, or bleeding related to the primary tumor. 8. No previous any systemic anticancer therapy for colon cancer disease. 9. Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment Exclusion Criteria: 1. Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization. 2. Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment. 3. Heart failure grade III/IV (NYHA-classification). 4. Unresolved toxicity higher than CTCAE v.5.0 Grade 1 attributed to any prior therapy/procedure. 5. Subjects with known allergy to the study drugs or to any of its excipients. 6. Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study. 7. Breast- feeding or pregnant women 8. Lack of effective contraception.
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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 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.