Can an immunotherapy cocktail make rectal tumors disappear before surgery?
NCT ID NCT05585814
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether giving pembrolizumab, bevacizumab, and chemotherapy before surgery can improve outcomes for people with a common type of locally advanced rectal cancer. The cancer must be microsatellite stable, which typically does not respond well to immunotherapy alone. Researchers will measure how many tumors shrink or disappear completely, and whether surgeons can remove them with clear margins. The study enrolls 30 adults with rectal adenocarcinoma that has spread into nearby tissue but not to distant organs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of capecitabine, oxaliplatin, bevacizumab, and pembrolizumab given before surgery
- What this could lead to
- If it works, this combination could shrink rectal tumors before surgery, raising the chance of complete removal and possibly avoiding the need for a permanent colostomy.
- What could go wrong
- This is a small, early-phase trial with only 30 participants. The added drugs may increase side effects, and the benefit over standard chemotherapy alone is not yet proven.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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May 2023
- Expected to finish
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May 2027
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: * Histologically confirmed rectal adenocarcinoma with cT3+N+M0 * Immunohistochemistry and/or genetic testing confirmed pMMR/MSS * Initial diagnosed or recurrent patients will be accepted, patients with recurrence should not have received any treatment include chemotherapy, targeted therapy or immunotherapy within 1 month or radiotherapy within 1 year * Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and haven't received any local treatment. * Eastern Cooperative Oncology Group (ECOG) 0-1. * Absence of distant metastasis confirmed by CT, MRI or PET/CT * Adequate hematologic and organ function, defined by protocol-specified laboratory test results, obtained within 7 days before first dose. Absolute neutrophil count ≥1500/mm3, platelet ≥100,000/mm3, Hb ≥10g/dl, serum creatinine ≤1.5 times ULN, creatinine clearance rate ≥50mL/min, ALT and AST ≤2.5 times ULN, INR or aPTT ≤1.5 times ULN (INR ≤2 times ULN and aPTT in normal range for patients who are on prophylactic anticoagulant therapy within 14 days before study treatment), total bilirubin level ≤2 times ULN (within 7 days before study treatment). * Women of childbearing age should confirm that serum pregnancy test is negative and agree to use effective contraceptive methods during study treatment and the following 60 days. * Life expectancy\> 3 months * Signed and written informed consent Exclusion Criteria: * Previously received anti-PD1 or anti-PDL1 or anti-PDL2 or anti-CTLA4. * Uncontrolled active bleeding from the primary tumor or intestinal obstruction. * Contraindications of bevacizumab * Hypersensitivity to other monoclonal antibodies. * Any active, known or suspected autoimmune disease. * Uncontrolled pleural effusion, pericardial effusion, or ascites to a moderate or greater extent. * History of one of the following diseases: idiopathic pulmonary fibrosis, organized pneumonia (eg. bronchiolitis obliterans), drug-induced pneumonia, idiopathic pneumonia and interstitial pneumonia, or evidence of active pneumonia through enhanced chest CT screening. * Major surgery within 4 weeks before enrollment and haven't fully recovered from the previous surgery. * Active bleeding or abnormal coagulation (aPTT \>43s or INR \>1.5 times ULN), or having a tendency to bleed or receiving thrombolytic or anticoagulant therapy. * Previously received allogeneic stem cell or parenchymal organ transplantation. * Any significant clinical or laboratory abnormality that the investigator considers to influence the safety assessment, eg. uncontrolled active infection, uncontrolled diabetes, hypertension that cannot be reduced to normal range with monotherapy, grade II or above peripheral neuropathy, congestive heart failure, heart disease (class II or higher) as defined by the New York College of Cardiology, myocardial infarction within 3 months prior to enrollment, unstable arrhythmias, unstable angina pectinis, chronic kidney disease, abnormal thyroid function and previous or co-existing malignancies. * History of uncorrected serum electrolyte disturbances such as potassium, calcium and magnesium. * HIV infection. * Active hepatitis B or hepatitis C. * Pregnancy or lactation period, or unwilling to use contraception during the trial. * With other malignancy within 5 year, except cervical carcinoma in situ, basal or squamous skin cancer, local prostatic carcinoma and ductal carcinoma in situ. * Use corticosteroids (dose of prednisone or similar drugs\> 10mg/day) or other immunosuppressive agents within 14 days before enrollment. * Patients with active tuberculosis (TB) who are receiving anti-TB treatment or have received anti-TB treatment within 1 year. * Active infection, or treatment with oral or intravenous antibiotics within the first 2 weeks prior to neoadjuvant therapy, except prophylactic administration. * Anti-infective vaccine (eg. influenza vaccine, varicella vaccine, etc.) injection within 4 weeks before neoadjuvant therapy. * Previous participation in other clinical trials within 4 weeks before neoadjuvant therapy. * Any other disease, metabolic disorder, abnormal physical examination or abnormal laboratory results that may constrain the use of trial drug, or affect the reliability of study results, or lead to high risk of treatment complications, or affect patient compliance.
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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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Shanghai Changzheng Hospital
Shanghai, China
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