New combo therapy aims to spare lymph nodes and boost rectal cancer outcomes
NCT ID NCT06507371
First seen Jun 25, 2026 · Last updated Jul 01, 2026 · Updated 3 times
Summary
This Phase III trial tests whether a modified short-course radiation that spares nearby lymph nodes, combined with chemotherapy (CAPOX) and the immunotherapy drug tislelizumab, works better than standard radiation plus chemotherapy for people with a certain type of rectal cancer (MSS). The study enrolls 170 patients with middle or low rectal cancer who want to avoid permanent colostomy. The main goal is to see if the new approach leads to a complete disappearance of the tumor after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tislelizumab (PD-1 antibody), capecitabine, oxaliplatin, and node-sparing short-course radiotherapy
- What this could lead to
- If successful, this could offer a more effective, less toxic treatment for rectal cancer that avoids damaging healthy lymph nodes and may help more patients avoid permanent colostomy.
- What could go wrong
- This is a Phase III trial, but the combination of immunotherapy and radiation is still experimental. Side effects from chemotherapy and immune-related reactions are possible, and the benefit over standard treatment is not yet proven.
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 170 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- 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 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. Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy. 2. Male or Female aged 18-75. 3. Patients diagnosed with low rectal cancer within 10 cm from the lower edge of the tumor to the anal verge by pelvic MRI and anorectoscopy, the clinical stage is cT3-4bN0/+M0, and the lymph nodes are limited to the mesorectum. 4. Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive. 5. Eastern Cooperative Oncology Group (ECOG) score 0-1. 6. No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation). 7. Laboratory tests indicating no contraindications to radiotherapy, chemotherapy and immunotherapy. 8. Informed consent form signed. Exclusion Criteria: 1. Patients with a previous history of malignant tumors besides rectal cancer. 2. Patients with distant metastases before enrollment. 3. Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT. 4. Patients with obstruction, perforation, or bleeding that require emergency surgery. 5. Patients with severe concomitant diseases and estimated survival time ≤ 5 years. 6. Allergic to any component of the therapy. 7. Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy. 8. Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening. 9. Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities. 10. Patients with congenital or acquired immune deficiency (such as HIV infection). 11. Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc. 12. Other conditions that investigators consider not suitable for this study.
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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.
Contacts and locations
Locations
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Sir Run Run Shao hospital
Hanzhou, Zhejiang, 310016, China
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Other studies related to the condition(s) this trial covers.
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