New combo therapy may help rectal cancer patients avoid surgery
NCT ID NCT07561060
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Mar 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. 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.
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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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Shanghai Zhongshan Hospital, Shanghai
RECRUITINGShanghai, Shanghai Municipality, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Immunotherapy added to standard treatment aims to save the anus in Ultra-Low rectal cancer
- New injectable drug tested against Hard-to-Treat solid tumors
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- 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