New combo therapy aims to skip radiation for rectal cancer patients
NCT ID NCT06688786
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new approach for people with locally advanced rectal cancer that has a common genetic profile (MSS/pMMR). Instead of standard radiation before surgery, participants receive a combination of chemotherapy (mFOLFOX6) and an immunotherapy drug (PD-1 antibody). The goal is to shrink the tumor, reduce side effects from radiation, and protect bowel function. About 30 adults aged 18-75 are taking part.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2024
- Expected to finish
-
Dec 2027
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 to 75 years
- 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. Advanced (cT3-4NxM0 or cTxN+M0) rectal cancer with the lower tumor margin within 15 cm of the anal verge 2. Histopathology confirmed adenocarcinoma with an pMMR/MSS genetic profile. 3. Absence of bowel obstruction, or bowel obstruction relieved by proximal colostomy. 4. Age: 18-75 5. ECOG: 0-1 6. No prior chemotherapy, radiotherapy, targeted therapy, or immunotherapy received. 7. Female participants must be non-lactating, with a negative pregnancy test result. Exclusion Criteria: 1. Patients with distant metastasis 2. History of receiving chemotherapy, radiotherapy, targeted therapy, or immunotherapy. 3. Active autoimmune disease requiring systemic treatment within the 2 years prior to enrollment. 4. History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ or basal cell carcinoma of the skin. 5. History of HIV infection, or active chronic hepatitis B or C with high viral DNA copy numbers. 6. Patients with active tuberculosis currently receiving anti-tuberculosis treatment or treated with anti-tuberculosis therapy within the past year prior to screening. 7. Known or suspected allergy to the study drug or any study-related medications administered. 8. Presence of severe cardiovascular or cerebrovascular disease. 9. Within 14 days prior to the first dose, presence of a severe active or uncontrolled infection requiring systemic therapy, or unexplained fever \>38.5°C. 10. Receiving systemic corticosteroid treatment or other immunosuppressive agents within 14 days prior to the first dose, or immunostimulants within 4 weeks. 11. History of confirmed neurological or psychiatric disorders, including epilepsy or dementia. 12. The participant may be unable to complete the study due to other reasons, or the investigator considers them unsuitable for inclusion. 13. Refusal to sign the informed consent form.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Locally advanced rectal cancer (LARC) 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.
Contacts and locations
Locations
-
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a diet that starves cancer cells boost rectal cancer treatment?
- Can a drug combo make rectal cancer disappear before surgery?
- Can a gut bacteria transplant help immunotherapy wipe out rectal cancer before surgery?
- New combo therapy aims to shrink rectal tumors before Surgery—Could spare some patients the knife
- New combo therapy aims to spare organs in High-Risk rectal cancer
- New drug duo takes on tough rectal cancer