New Pre-Surgery combo aims to shrink rectal tumors and save the rectum
NCT ID NCT07521605
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment plan for adults with locally advanced rectal cancer that hasn't spread. Participants get a week of radiation, then 8 cycles of three drugs (chemotherapy and immunotherapy) before surgery. The goal is to shrink the tumor enough to cure the cancer or avoid removing the rectum entirely.
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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 44 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2034
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. Aged 18 to 75 years, male or female. 2. Histologically confirmed diagnosis of rectal adenocarcinoma. 3. Confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) status by immunohistochemistry or PCR methods. 4. Locally advanced disease assessed by pelvic MRI, classified as cT3-4aN0M0 or any T stage with node-positive (N+) disease, without distant metastasis (M0), according to the AJCC 8th edition staging system. 5. The lower edge of the tumor is located within 10 cm from the anal verge (defined as low/mid rectal cancer). 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Adequate bone marrow, hepatic, and renal function, defined as: Absolute Neutrophil Count (ANC) ≥ 1.5 x 10⁹/L,Platelet count ≥ 100 x 10⁹/L,Hemoglobin ≥ 90 g/L,Total Bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN),Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 x ULN,Serum creatinine ≤ 1.5 x ULN or Creatinine Clearance ≥ 50 mL/min (calculated by Cockcroft-Gault formula) 8. Voluntarily participates in the study, signs the informed consent form, demonstrates good compliance, and is able to cooperate with follow-up procedures. Exclusion Criteria: 1. Evidence of distant metastasis (M1 disease) on baseline imaging. 2. Previous radiotherapy to the pelvis, or any prior systemic chemotherapy, targeted therapy, or immunotherapy for colorectal cancer. 3. History of other active malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or other localized tumors considered cured by local treatment. 4. Any of the following uncontrolled conditions or comorbidities: 1)Severe active infection requiring systemic therapy. 2)Unstable angina, myocardial infarction, or congestive heart failure (NYHA Class II-IV) within the last 6 months. 3)Uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders that would compromise the ability to provide informed consent or comply with study procedures. 5\. Known history of severe immunodeficiency or active autoimmune disease requiring systemic immunosuppressive therapy (e.g., corticosteroids at doses \> 10mg/day prednisone equivalent) within the past 2 years. 6\. Known history of hypersensitivity to any component of the study drugs (Liposomal Irinotecan, Capecitabine, Camrelizumab) or history of severe hypersensitivity reactions to other monoclonal antibodies. 7\. Pregnant or lactating women, or subjects of childbearing potential who are unwilling to use highly effective contraception during the study period and for at least 6 months after the last dose of study treatment. 8\. Any other condition or circumstance that, in the opinion of the investigator, would compromise the patient's safety or adherence to the protocol (e.g., inability to swallow oral medications, active gastrointestinal bleeding, intestinal obstruction).
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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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Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can immunotherapy plus chemo melt colorectal tumors before surgery?
- Can drug cocktail spare rectal cancer patients from surgery?
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- MRI and microbes: a new way to predict rectal cancer outcomes?
- Can a new drug shield rectal cancer patients from Radiation's worst side effects?