Radiation that skips lymph nodes may help rectal cancer patients keep their rectum
NCT ID NCT07068763
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a new treatment for early-stage rectal cancer that has not spread to lymph nodes. Instead of radiating the whole pelvis, doctors give a short course of radiation only to the tumor, followed by chemotherapy and an immunotherapy drug. The goal is to shrink the cancer completely so patients can avoid major surgery and a permanent colostomy. The study enrolls 52 adults with a specific type of rectal cancer (MSS) and will measure how many achieve a complete response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- short-course radiation to the tumor only, capecitabine chemotherapy, and a PD-1/CTLA-4 bispecific antibody (Aiparolitoworixureli injection)
- What this could lead to
- If successful, this approach could allow more patients with early rectal cancer to avoid major surgery and a permanent colostomy by achieving a complete response with a combination of targeted radiation, chemotherapy, and immunotherapy.
- What could go wrong
- This is a small, early-phase (phase 2) trial with only 52 participants, so results may not apply to all patients. The combination therapy may cause significant side effects, and the long-term cancer control rates are still unknown.
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 52 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Dec 2029
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. Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy. 2. Male or Female aged 18-80. 3. Patients diagnosed with low rectal cancer within 7 cm from the lower edge of the tumor to the anal verge by pelvic MRI and rectal ultrasound, the clinical stage is cT2-3N0M0. 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. 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 metastatic regional or non-regional 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. Contraindications to radiotherapy and chemotherapy. 9. Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening. 10. 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. 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. Other conditions that investigators consider not suitable for this study. 12. Patient not suitable for participating by other concerns of researchers.
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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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Sir run run shaw hospital
RECRUITINGHangzhou, Zhejiang, China
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Other studies related to the condition(s) this trial covers.
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- Blood test aims to catch Cancer's return earlier
- Blood test guides immunotherapy for hidden cancer cells
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?