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Blood test may predict rectal cancer treatment success
NCT ID NCT07393048
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing a new blood test that looks for tiny bits of cancer DNA to see if it can predict how well treatment works for people with advanced rectal cancer. Researchers will collect blood and tissue samples from 60 patients before, during, and after treatment. The goal is to create a model that helps doctors know early if the cancer is responding, but this study does not offer a new treatment or cure.
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.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- 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.
Who is studied
"Enrolled subjects must be 18-75 years old, pathologically confirmed with rectal adenocarcinoma (MRI stage II-III), with a tumor inferior margin ≤10 cm, resectable via surgery, ECOG performance status 0-1, normal major organ function, no prior relevant treatment, ability to take oral medications, signed informed consent, and no surgical contraindications. Detailed eligibility criteria can be found in the study protocol." "Subjects with a history of drug allergy, prior cancer treatment, active or past autoimmune disease, immunodeficiency, severe heart disease, other malignant tumors (except low-risk ones) within the past five years, pregnancy or lactation, or other factors affecting safety and compliance will be excluded from this study. Detailed eligibility criteria can be found in the study protocol."
- 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: Signed a written informed consent form and voluntarily participated in this study * 2: Aged 18-75 years, regardless of sex * 3: Histopathologically confirmed rectal adenocarcinoma * 4: Clinical stage II-III as assessed by MRI (according to the AJCC 8th edition) * 5: Distance from the lower tumor margin to the anal verge ≤10 cm * 6: Surgically resectable * 7: Able to swallow tablets normally * 8: ECOG PS 0-1 * 9: No prior antitumor therapy for rectal cancer, including radiotherapy, chemotherapy, or surgery * 10: Scheduled to undergo surgical treatment after completion of neoadjuvant therapy * 11: No surgical contraindications * 12: Normal function of major organs, including: complete blood count, blood biochemistry, and coagulation function Exclusion Criteria: * 1: History of allergy to monoclonal antibodies, any component of tislelizumab, or capecitabine * 2: Prior or ongoing receipt of any tumor-directed surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc * 3: Presence of any active autoimmune disease or history of autoimmune disease * 4: History of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation * 5: Poorly controlled cardiac clinical symptoms or diseases, including but not limited to: heart failure of NYHA class II or above, unstable angina, myocardial infarction within the past year, or clinically significant supraventricular or ventricular arrhythmia that remains poorly controlled without or despite clinical intervention * 6: Diagnosis of another malignancy within 5 years prior to the first use of the study drug, except for malignancies with low risk of metastasis or death (5-year survival rate \>90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix, which may be considered for inclusion * 7: Pregnant or lactating women * 8: Other factors, as judged by the investigator, that may lead to premature termination of the study, such as other severe diseases (including psychiatric disorders) requiring concomitant treatment, alcohol abuse, drug abuse, family or social factors, or any condition that may affect the safety or compliance of the participant
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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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Beijing Friendship Hospital
RECRUITINGBeijing, Beijing Municipality, 100050, China
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- New drug duo takes on tough rectal cancer