New combo therapy aims to boost rectal cancer survival
NCT ID NCT07113275
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether adding an immunotherapy drug (HLX10) to standard chemotherapy and radiation before surgery improves outcomes for people with locally advanced rectal cancer. It compares short-course versus long-course radiation, both followed by immunotherapy and chemotherapy. The study aims to enroll 444 participants and will track cancer recurrence and survival over three years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HLX10 (an immunotherapy drug), capecitabine, oxaliplatin, and radiotherapy
- What this could lead to
- If successful, this could lead to a more effective treatment approach for locally advanced rectal cancer, potentially improving survival and reducing recurrence.
- What could go wrong
- This is a large phase 3 trial, but results are not guaranteed. Immunotherapy can cause immune-related side effects, and the best radiotherapy schedule is 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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 444 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- 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 or their family members agree to participate in the study and sign the informed consent form; 2. Age 18-75 years, male or female; 3. Histologically confirmed Locally Advanced rectal adenocarcinoma; 4. Immunohistochemistry and/or genetic testing confirmed pMMR/MSS; 5. inferior margin ≤ 10 cm from the anal verge; 6. ECOG performance status score is 0-1; 7. Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc; 8. There was no operative contraindication; 9. Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 100×109/L; Hemoglobin ≥90 g/L; Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum creatinine ≤1.5 times the upper limit of normal value or creatinine clearance rate ≥50 mL/min; International normalized ratio (INR) ≤ 1.5 × ULN; Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; 10. Urinary protein \< 2+ or 24-hour urinary protein excretion \< 1 g at baseline. Exclusion Criteria: 1. Patients with MSI-H/dMMR LARC; 2. Subjects who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor immunomodulatory mechanisms; 3. Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety, interfere with the process of obtaining informed consent, affect subject compliance, or confound the safety assessment of the investigational product(s).
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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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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Radiation plus targeted antibody tested in older head and neck cancer patients
- Can software and expert review unlock curative radiation for Hard-to-Treat cancers?
- Tiny gadolinium particles aim to make brain radiation hit harder
- Can immunotherapy plus chemo melt colorectal tumors before surgery?
- Can drug cocktail spare rectal cancer patients from surgery?