New combo therapy aims to save rectums from surgery in rectal cancer trial
NCT ID NCT06204094
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing a new approach for people with a certain type of locally advanced rectal cancer. The treatment combines short-course radiation (sparing lymph nodes), two chemotherapy drugs (capecitabine and oxaliplatin), and an immunotherapy drug (sintilimab). The goal is to see if this combination can make the cancer disappear completely, allowing some patients to avoid surgery and keep their rectum. The study plans to enroll 37 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sintilimab (a type of immunotherapy), capecitabine (chemotherapy), oxaliplatin (chemotherapy), and short-course radiation
- What this could lead to
- If successful, this approach could help more people with rectal cancer avoid major surgery and preserve their rectum, while still effectively treating the cancer.
- What could go wrong
- This is a small, early-phase trial with only 37 participants, so results may not apply to everyone. The combination of treatments may cause significant side effects, and the cancer could still return.
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 37 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Sep 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: * Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy. * Male or Female aged 18-75. * 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 cT2N+M0/cT3-4N0/+M0, the lymph nodes are limited to the mesorectum. * 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. * Eastern Cooperative Oncology Group (ECOG) 0-1. * No previous treatment(including anti-tumor therapy、immunotherapy or pelvic radiation). * Adequate hematologic, hepatic, renal, thyroid and cardiac function: white blood cells ≥3500/mm3, neutrophils ≥1800/mm3, platelets ≥100,000/mm3, hemoglobin ≥100 g/L; activated partial thromboplastin time, prothrombin time and international normalized ratio ≤1.5 × ULN; aspartate aminotransferase and alanine aminotransferase ≤3.0 × upper limit of normal (ULN), bilirubin ≤1.25 × ULN, serum albumin ≥28 g/L. creatinine clearance ≥50 mL/mi, creatinine ≤1.5 × ULN; * Informed consent form signed. Exclusion Criteria: * Patients with a previous history of malignant tumors besides rectal cancer. * Patients with distant metastases before enrollment. * Patients with positive internal or external iliac lymph nodes are assessed by MRI or CT. * Patients with obstruction, perforation, or bleeding that require emergency surgery. * Patients with severe concomitant diseases and estimated survival time ≤ 5 years. * Allergic to any component of the therapy. * Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, or mucinous adenocarcinoma. * Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy. * Patients who have received any other experimental drug (including immunotherapy) or participated in another interventional clinical trial within 30 days before screening. * 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). * 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.
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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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Zhejiang University Affiliated Jinhua Hospital
RECRUITINGJinhua, Zhejiang, 0579, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can immunotherapy plus chemo melt colorectal tumors before surgery?
- Can drug cocktail spare rectal cancer patients from surgery?
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- Can a Butter-Derived supplement protect the gut during cancer radiation?
- Can an immunotherapy cocktail make rectal tumors disappear before surgery?
- MRI and microbes: a new way to predict rectal cancer outcomes?