Immunotherapy plus chemo shows promise against rectal cancer
NCT ID NCT06647680
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether giving a combination of chemotherapy (oxaliplatin and capecitabine) and the immunotherapy drug tislelizumab before surgery can shrink or eliminate tumors in people with locally advanced rectal cancer. About 35 participants will receive three cycles of the drug combo, then undergo surgery and be followed for up to four years. The goal is to see how many patients have a complete response, meaning no cancer remains detectable 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 inhibitor) combined with chemotherapy (oxaliplatin and capecitabine)
- What this could lead to
- If successful, this combination could improve the chance of eliminating the tumor before surgery, potentially reducing the need for more aggressive treatments.
- What could go wrong
- This is a small, early-phase study (35 people) with no control group, so results may not apply broadly. Side effects from chemo and immunotherapy can be serious.
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 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2027
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: * Be willing and able to provide written informed consent for the trial * Age 18 years or greater * Pathologically proven diagnosis of adenocarcinoma of the rectum * Clinically determined to be stage T3 or T4, N0-N2, and M0 * Be fully active, able to carry on all pre-disease performance without restriction or Restricted in physically strenuous activity. * Contrast-enhanced imaging of the abdomen and chest by CT to exclude distant metastases and provide local tumor stage * Preoperative ECOG status score 0-1 * Preoperative ASA grade I-III * Adequate bone marrow function * Adequate renal and liver function * No active second cancers * Be willing and able to comply with all aspects of the protocol * Women of childbearing potential must have used reliable contraception or have had a pregnancy test result within 7 days prior to enrollment. Be negative and willing to use an adequate method of contraception for the duration of the trial and for 8 weeks after the last administration of the trial drug. * Adequate bone marrow function defined as follows: Absolute neutrophil count (ANC) ≥ 1,200 cells/mm3 Platelets ≥ 100,000 cells/mm3 Hemoglobin ≥ 8.0 g/dl. * Adequate hepatic function within within 28 days before registration on this study:total bilirubin must be ≤ ULN (upper limit of normal) for the lab unless the patient has a bilirubin elevation \> ULN to 1.5 x ULN due to Gilbert\'s disease or similar syndrome involving slow conjugation of bilirubin; and AST and ALT must be ≤3 x ULN for the lab If AST and/or ALT is ≥ ULN but ≤ 3 x ULN, serologic testing for Hepatitis B and C must be performed and results for viral infection must be negative. * Adequate renal function within 28 days before randomization defined as serum creatinine ≤ 1.5 x ULN for the lab or calculated creatinine clearance \> 30 mL/min Exclusion Criteria: * Age less than 18 years * Pregnant or breastfeeding women * Prior invasive malignancy unless disease free for a minimum of three years * Preoperative body temperature ≥ 38°C or concurrent infectious diseases requiring systemic therapy; * Severe mental illness; * Severe abnormal heart, lung and kidney function * History of unstable angina pectoris or myocardial infarction within 6 months; * History of cerebral infarction or cerebral hemorrhage within 6 months; * Patients with abnormal coagulation function; * Have a history of psychotropic drug abuse or have a mental disorder; * Continuous use of glucocorticoids within 1 month (except topical application); * Patient has participated in or is participating in other clinical studies (within 6 months); * According to the judgment of the investigator, it endangers the patient\'s health or affects the experimental results.
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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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The affiliated hospital of Qingdao university
RECRUITINGQingdao, Shandong, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New injectable drug tested against Hard-to-Treat solid tumors
- Could a nasal tube replace a temporary ileostomy after rectal cancer surgery?
- Blood test aims to catch Cancer's return earlier
- Blood test guides immunotherapy for hidden cancer cells
- Can Pre-Surgery radiation stop rectal cancer from returning?
- Can a counseling program restore intimacy after rectal cancer?