Can precision radiation and immunotherapy team up against abdominal colorectal cancer?
NCT ID NCT07815834
First seen Sep 11, 2026 · Last updated Sep 11, 2026
Summary
Researchers are testing whether adding targeted radiation plus the immunotherapy drug cadonilimab to standard second-line chemotherapy helps adults with colorectal cancer that has spread only to the peritoneum. The trial enrolls about 198 participants and randomly assigns them to receive either the combined treatment or standard chemotherapy alone. The main goal is to see whether the combination delays cancer growth longer than chemotherapy by itself, and to track side effects and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FAPI-guided hypofractionated radiotherapy combined with cadonilimab immunotherapy and standard second-line chemotherapy
- What this could lead to
- If it works, this could offer a way to control colorectal cancer that has spread only to the lining of the abdomen, a situation with few good options.
- What could go wrong
- The combination may not slow cancer more than standard chemotherapy, and adding radiation and immunotherapy could cause extra side effects. Results from this trial will not apply to cancers that have spread to other organs.
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 198 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 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 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. Histopathologically confirmed colorectal adenocarcinoma. 2. Tumors confirmed pMMR by immunohistochemistry or MSI-L/MSS via gene sequencing. 3. Metastases limited to peritoneum only, no metastases in other organs. 4. No moderate or massive ascites; only trivial physiological effusion without drainage requirement. 5. No symptomatic intestinal obstruction and no obstructive signs on imaging; patients can take food normally. 6. Baseline CT/MRI confirms peritoneal metastases. 7. Positive baseline FAPI PET/CT: at least one peritoneal mass lesion with long diameter ≥1 cm and markedly elevated SUVmax suitable for radiotherapy contouring. 8. At least one measurable lesion per RECIST v1.1 criteria. 9. Progression after first-line standard systemic therapy (FOLFOX/XELOX ± targeted agents); no prior second-line treatment received. 10. Peritoneal recurrence within 1 year after adjuvant fluoropyrimidine-based chemotherapy. 11. No moderate or massive ascites; only trivial physiological effusion without drainage requirement. 12. Voluntarily sign written informed consent and comply with scheduled study visits and treatment procedures. Exclusion Criteria: 1. Prior exposure to any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or other agents targeting T-cell co-stimulatory/checkpoint pathways. 2. Moderate or massive ascites requiring clinical intervention. 3. Partial or complete symptomatic intestinal obstruction. 4. Pregnant or breastfeeding women. 5. History of high-dose abdominal radiotherapy that prevents re-irradiation. 6. Diffuse miliary peritoneal metastases on FAPI PET/CT without definable target volume for radiotherapy. 7. Active autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.); systemic corticosteroids or other immunosuppressants required within 14 days before enrollment; severe underlying vital organ disease judged unsuitable for immunotherapy by investigators. 8. Poor compliance or other conditions judged inappropriate for study participation by investigators.
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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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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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