New combo therapy aims to shrink multiple colorectal tumors before surgery
NCT ID NCT06002789
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a PD-1 monoclonal antibody (immunotherapy) alone or combined with chemotherapy (mFOLFOX6) before surgery in people with multiple colorectal cancers. The goal is to shrink tumors and increase the chance of complete removal while preserving organs. The study enrolls 17 participants with specific genetic markers (dMMR/MSI-H).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1 monoclonal antibody (immunotherapy) and mFOLFOX6 chemotherapy
- What this could lead to
- If successful, this could offer a personalized treatment approach for people with multiple colorectal cancers, potentially reducing the need for extensive surgery and preserving more healthy tissue.
- What could go wrong
- This is a small, early-phase study with only 17 participants, so results may not apply to everyone. Immunotherapy and chemotherapy can cause serious side effects, and the treatment may not work for all tumor types.
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 17 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2022
- Expected to finish
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Dec 2028
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 80 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. Histological confirmation of simultaneous multiple primary colorectal cancer (sMPCC); 2. Tumor biopsy immunohistochemistry of at least one tumor lesion identified dMMR, including the expression loss of one or more of the four proteins MSH1, MSH2, MSH6 and PMS2; or at least one tumor lesion identified MSI-H by polymerase chain reaction or next-generation sequencing technique; 3. Clinical staging T3-4NxM0, with or without positive MRF, with or without positive EMVI; 4. Staging method: all patients undergo chest,abdominal and pelvic enhanced CT, rectal palpation, high resolution MRI examination,positive perienteric lymph node(LN): short diameter ≥10mm LN or LN with typical metastatic shape and MRI character, clinical data should be re-evaluated and judged by center evaluation group when there are contradictory stagings,distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI; 5. No intestinal obstruction symptom,or obstruction relieved after proximal colostomy; 6. No colorectal surgery history; 7. No chemotherapy or radiotherapy history; 8. No biopharmaceutical treatment history(such as monoclonal antibody), immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment; 9. No endocrinotherapy history restriction; 10. informed consent assigned. Exclusion Criteria: 1. Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within 6 months) or congestive heart-failure (CHF) \> NYHA grade II; 2. Severe hypertension not well controlled by drugs; 3. HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus DNA); 4. Active tuberculosis(TB), accepting anti-TB treatment or anti-TB treatment within 1 year before trial screen; 5. Other active clinical severe infection(NCI-CTC AE V5.0); 6. Outside pelvic distant metastasis evidences; 7. Dyscrasia, organ dysfunction; 8. Pelvic or abdominal radiotherapy history; 9. Epilepsy need treatments(Steroid or anti-epilepsy therapy); 10. Other malignant tumor history within 5 years; 11. Over abuse of drugs, medical and psychological or social conditions that might interfere patients or evaluation of the study results; 12. Any active autoimmune disease or autoimmune disease history (including but not restricted: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism, asthma need bronchodilators); 13. Any anti-infection vaccine injection 4 weeks before inclusion; 14. Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose\>10mg/day prednisolone or equivalent hormone); 15. Known or suspicious allergy to any study related drugs; 16. Any unstable state might cause damage to the safety and compliance of patients; 17. Pregnant or breast feeding women who has ability to have children while without contraception; 18. Refuse to sign informed consent.
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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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The Sixth Affiliated Hospital, Sun Yatsen University
RECRUITINGGuangzhou, Guangdong, China
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- The gatekeepers of tumors: scientists probe how blood vessels let immune cells in
- New Antibody-Drug conjugate put to the test against Hard-to-Treat cancers