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New combo therapy shows promise for saving rectal cancer Patients' anuses
NCT ID NCT05215379
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding immunotherapy to standard chemoradiation before surgery helps people with a specific type of ultra-low rectal cancer (MSS type). The goal was to increase the chance of a complete response, meaning the tumor disappears, and to preserve the anus and avoid permanent colostomy. The trial involved 201 patients who strongly wanted to keep their anus and were willing to undergo neoadjuvant treatment. Results aim to provide high-level evidence for a new treatment approach.
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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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201 people
The number who actually took part.
- Started
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Oct 2022
- Finished
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Jun 2025
- 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: Ultra low rectal cancer patients evaluated by multidisciplinary team to perform APR * Patients who have a strong desire to preserve the anus and are willing to accept neoadjuvant treatment * 18 years old ≤ age ≤ 75 years old, no gender limit; * Colonoscopy, intracavitary ultrasound and pelvic high-resolution MRI (or enhanced CT) were diagnosed as extremely low rectal cancer within 5 cm from the lower edge of the tumor to the anal edge. The baseline clinical stage is T1-3aN0-1M0, and the size of the tumor \<1/2 circle; * Histopathological diagnosis of rectal adenocarcinoma; tumor biopsy immunohistochemistry showed pMMR, that is, MSH1, MSH2, MSH6 and PMS2 four proteins are positive, or genetic testing suggests MSI-L or MSS. * The patient has good compliance and can come to the hospital for reexamination as required; * ECOG physical status score 0-1 points; * Have not received anti-tumor and immunotherapy before being selected; * 8\. Laboratory inspections must meet the following standards: i. White blood cell count ≥3.5×109/L, absolute neutrophil count ≥1.8×109/L, platelet count ≥100×10\^9/L, hemoglobin ≥100g/L; ii. INR≤1.5, and APTT≤1.5 times the upper limit of normal value or partial prothrombin time (PTT)≤1.5 times the upper limit of normal value; iii. Total bilirubin≤1.25 times the upper limit of normal; ALT and AST≤5 times the upper limit of normal; iv. 24h creatinine clearance rate ≥50mL/min or blood creatinine ≤1.5 times the upper limit of normal. * Voluntarily sign the informed consent form; Exclusion Criteria: * History of other malignant diseases in the past 5 years; * Patients with metastases ; * Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery; * Those who are known to be allergic to capecitabine, oxaliplatin, PD-1 monoclonal antibody and other drugs; * Patients with poorly differentiated adenocarcinoma, signet ring cell carcinoma, and mucinous adenocarcinoma; * The patient is accompanied by any unstable systemic diseases, including but not limited to: severe infection, uncontrolled diabetes, hypertension that cannot be controlled by drugs, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardium Infarction, congestive heart failure, severe arrhythmia requiring medication, liver, kidney or metabolic diseases; diseases that affect the life of the patient. * The patient's accompanying diseases (such as mental illness, etc.) or conditions (such as alcohol or drug abuse, etc.) will increase the patient's risk of receiving experimental drug treatment or affect the patient's compliance with the trial requirements, or may confuse the research results; * Within 30 days before screening, the patient has received any other experimental drug treatment or participated in another interventional clinical trial; * Women who are pregnant or breastfeeding or who intend to become pregnant or breastfeeding during the study period; men or women who are unwilling to take effective contraceptive measures; * The investigator judges that the patient is not suitable to participate in other situations such as the clinical trial.
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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.
Contacts and locations
Locations
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Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, 200433, 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
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can precision radiation and immunotherapy team up against abdominal colorectal cancer?
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?
- Can digital surveys capture the full toll of rectal cancer treatment?
- Can a Three-Dose immunotherapy cure early lung cancer without surgery?