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New combo therapy may help rectal cancer patients avoid surgery

NCT ID NCT07561060

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a treatment plan for people with low rectal cancer that can be removed with surgery. Participants receive chemotherapy and an immunotherapy drug called tislelizumab before surgery. The goal is to see if this combination can make the cancer disappear completely, allowing some patients to avoid surgery and keep their rectum. About 50 adults with a specific type of rectal cancer will take part.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 50 people

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

Started

Jan 2024

Expected to finish

Mar 2028

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: 1. Able to provide written informed consent, understand and comply with the requirements and evaluation schedule 2. ≥18, ≤75 years old 3. Histologically confirmed rectal adenocarcinoma 4. immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS confirmed MSI-L or MSS 5. The tumor is within 3 cm of the dentate line. through colonoscopy, digital anal examination or MRI 6. clinical stage cT1-3 N 0-1M0 (the 8th UICC/AJCC; T and N is evaluated by MRI) 7. Resectable primary tumor assessed by the Investigator 8. Have not received any anti-tumor treatment for rectal cancer 9. ECOG PS ≤ 1 10. Adequate organ function 11. Female subjects with the ability to become pregnant must have a serum pregnancy test with a negative result within 72 hours before the first dose, and be willing to use highly effective contraceptive methods during the trial and 120 days after the last dose. Male subjects whose partners are women of childbearing potential should be surgically sterilized or agree to use a highly effective method of contraception during the trial and for 120 days after the last dose. Exclusion Criteria: 1. Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma 2. Have received any treatments for rectal cancer, or evidence of distant metastasis 3. Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d 4. Presence or in high risk of obstruction, perforation or bleeding; 5. Not suitable for long-course radiotherapy 6. Cannot tolerate surgery 7. ≥2 colorectal cancer lesions at the same time 8. Contraindications for MRI examination 9. Other malignant tumors in the past or at the same time 10. Have an active autoimmune disease requiring systemic therapy within the past 2 years 11. HIV infection 12. Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers (HBV DNA \> 500 IU/mL) or active HCV carriers with detectable HCV RNA; 13. Hypersensitivity to any ingredient of tislelizumab, capecitabine, and oxaliplatin or to any component of the container 14. Other conditions judged by the researcher that do not meet the enrollment requirements

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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

  • Shanghai Zhongshan Hospital, Shanghai

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

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