New combo may let some colon cancer patients skip surgery
NCT ID NCT06903858
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two drugs, toripalimab and celecoxib, in people with a specific type of colorectal cancer (dMMR or MSI-H) that has not spread far. The goal is to see if the treatment can make the tumor disappear completely, so some patients might not need surgery. About 105 adults will take part, and doctors will use scans and tests to decide who can safely avoid an operation.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jun 2025
- Expected to finish
-
Apr 2031
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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. Signed informed consent and willingness/compliance with study procedures. 2. Age ≥18 years. 3. Histologically confirmed colorectal adenocarcinoma. 4. ECOG performance status 0-1. 5. Locally advanced primary tumor (T3/T4 and/or N+) confirmed by CT/MRI (pelvic MRI for rectal cancer). 6. dMMR (IHC) or MSI-H (PCR) status. 7. No prior anti-cancer therapy for colonrectal cancer (surgery/chemotherapy/targeted therapy/radiation). 8. Adequate organ function 9. For women of childbearing potential: negative pregnancy test and contraception use during and for 3 months post-treatment. Male participants with fertile partners must use contraception. 10. Willingness to adhere to study requirements. Exclusion Criteria: 1. Presence of distant metastases (M1) confirmed by CT/MRI or PET-CT (at least covering the chest, abdomen, and pelvis). 2. Complete intestinal obstruction, active bleeding, or perforation requiring emergency surgery. 3. Inability to achieve complete resection of the primary colorectal tumor. 4. History or concurrent active malignancy (except malignancies cured ≥5 years ago or adequately treated carcinoma in situ). 5. Prior treatment with anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies targeting T-cell co-stimulation or checkpoint pathways. 6. Major surgery (e.g., laparotomy, thoracotomy, organ resection via laparoscopy) or severe trauma within 4 weeks before enrollment (surgical incision must be fully healed). 7. Thromboembolic events (e.g., cerebrovascular accident, transient ischemic attack, pulmonary embolism, deep vein thrombosis) within 12 months before enrollment. 8. Active coronary artery disease, severe/unstable angina, or newly diagnosed angina/myocardial infarction within 12 months before enrollment. 9. New York Heart Association (NYHA) Class II or higher congestive heart failure (see Appendix 3). 10. HIV infection, AIDS, or untreated active hepatitis (HBV-DNA ≥500 IU/mL; HCV-RNA above detection limit). 11. Active inflammatory bowel disease or other colorectal disorders causing chronic diarrhea. 12. Active, known, or suspected autoimmune disease (exceptions: stable conditions like type 1 diabetes, hypothyroidism on hormone replacement, or skin disorders without systemic treatment, e.g., vitiligo, psoriasis, alopecia). 13. Interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, acute pneumonia). 14. Residual toxicity ≥Grade 2 (per CTCAE v5.0) from prior therapies (except anemia, alopecia, skin pigmentation). 15. Known or suspected hypersensitivity to any study-related drugs. 16. Pregnancy or lactation. 17. Women of childbearing potential (last menstruation \<2 years ago) or fertile men unwilling to use effective non-hormonal contraception. 18. Any unstable medical condition compromising safety or protocol compliance.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Colorectal cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
The Sixth Affiliated Hospital, Sun Yat-sen University
RECRUITINGGuangzhou, Guangdong, 510655, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a lab test tell which chemo works for colon cancer?
- Can MRI and computer models predict how well cancer drugs reach tumors?
- Gut bacteria may hold clues to why some cancer treatments work better
- Burning the edges: a new way to stop colon polyps from coming back
- Missed Follow-Up colonoscopies: do they raise the risk of advanced growths?
- A 2.2 mm scope could spot cancerous tissue in minutes, not days