New drug combo aims to shrink rectal tumors before surgery
NCT ID NCT07454720
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding two drugs (adebrelimab and SHR-8068) to standard chemoradiation helps shrink advanced rectal cancer before surgery. About 165 adults aged 18-75 with resectable tumors will participate. The goal is to see if more patients achieve a complete response (no cancer detectable) after treatment.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 165 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Nov 2035
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2. Male or female ≥ 18 years old and ≤75 years old. 3. ECOG performance status of 0-1. 4. An assessment of resectable locally advanced rectal. 5. Has not received any anti-tumor treatment for rectal cancer. 6. With a life expectancy of ≥2 years. 7. Male participants whose partners are fertile women and fertile female participants must take effective contraceptive measures together with their partners from the time of signing the informed consent form until 6 months after the last administration of the investigational drug or the last radiotherapy. Female participants with fertility must have a negative serum or urine test for human chorionic gonadotropin (HCG) within 7 days before the first administration of the drug (if the serum HCG test is positive, pregnancy should be ruled out and further discussion with the sponsor should be conducted), and they must be not in the lactation period. Exclusion Criteria: 1. Patients with rectal cancer who have experienced local recurrence after previous treatment. 2. Patients with concurrent colon tumors. 3. Patients with initially unresectable colorectal cancer as evaluated by researchers or those whose condition is determined by researchers to be intolerant to surgery. 4. Clinical or imaging examinations suggest the presence of intestinal obstruction or perforation, or those assessed by researchers as having a relatively high risk of perforation or bleeding. 5. With distant metastases. 6. Imaging examination of rectal cancer indicated positive lateral lymph nodes. 7. Having received surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. for tumors. 8. Female participants who are pregnant, breastfeeding or planning to become pregnant during the study period. 9. There are uncontrollable mental illnesses and other circumstances known to affect the completion of the research procedures, such as alcohol abuse, drug abuse or drug abuse, and criminal detention. 10. Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.
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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
2 sites. 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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Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430022, China
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Zhejiang Cancer Hospital
RECRUITINGHangzhou, Zhejiang, 310022, China