New combo therapy aims to shrink rectal tumors before surgery
NCT ID NCT07448077
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This study tests whether adding a drug called enlonstobart to short-course radiotherapy before surgery can improve outcomes for people with a specific type of advanced rectal cancer (pMMR). About 128 adults will be randomly assigned to receive either the standard treatment or the new combination. The main goal is to see if the cancer disappears completely or nearly completely before surgery.
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
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 128 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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Jun 2030
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 years and older
- 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.age \>=18 years old, female and male. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3.Histologically confirmed adenocarcinoma of the colon, and umor biopsy immunohistochemistry (IHC) indicates pMMR . 4.Staged as T3-4 NanyM0 or T1-2N+ M0 according to the AJCC 8th edition. 5.Rectal cancer: \<10 cm from the anal verge. 6.Adequate organ function: 1. Hematology : i. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L. ii. Platelet count ≥ 100 × 10⁹/L . iii. Hemoglobin ≥ 90 g/L. 2. Hepatic: i. Serum Total Bilirubin (TBil) ≤ 1.5 × ULN (Upper Limit of Normal). ii. AST and ALT ≤ 2.5 × ULN. iii. Creatinine ≤ 1.5 × ULN ; Renal: Calculated Creatinine Clearance (CrCl) ≥ 60 mL/min (calculated using the Cockcroft-Gault formula) 3. Coagulation: i. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN. 7\. Men and women of childbearing potential must agree to use effective contraceptive measures during the study and for 6 months after the last treatment. 8\. Willing and able to voluntarily provide written informed consent and comply with all scheduled treatments and follow-up assessments. Exclusion Criteria: 1. Pathological diagnosis of other special types, including but not limited to neuroendocrine carcinoma or squamous cell carcinoma. 2. Has previously received radiotherapy, targeted agents, or immune checkpoint inhibitors for the treatment of rectal cancer. 3. Active autoimmune disease, such as systemic lupus erythematosus or rheumatoid arthritis, necessitating ongoing immunosuppressive treatment. 4. Has active infection, including but not limited to HIV, or positive HBV/HCV viral load requiring antiviral therapy for control and stabilization. 5. Significant cardiovascular disease, such as myocardial infarction within 6 months prior to enrollment, unstable angina pectoris, or hypertension that remains uncontrolled above 160/100 mmHg despite optimal therapy. 6. History of other malignant tumors, excluding non-melanoma skin cancer and cervical carcinoma in situ that have been curatively treated and disease-free for ≥ 5 years. 7. Uncontrolled diabetes (HbA1c \> 8%) or thyroid dysfunction requiring medication for abnormal TSH. 8. Severe chronic intestinal conditions,including but not limited to Crohn's disease or active ulcerative colitis. 9. The investigators believe that patients were inappropriate for participation.
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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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Hebei Medical University Fourth Hospital
RECRUITINGShijiazhuang, Hebei, 050000, China