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Immunotherapy plus chemo shows promise against rectal cancer

NCT ID NCT06647680

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The affiliated hospital of Qingdao university

    RECRUITING

    Qingdao, Shandong, China

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Other studies related to the condition(s) this trial covers.