New cocktail aims to shrink rectal tumors before surgery
NCT ID NCT05731726
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is for people with a certain type of locally advanced rectal cancer (pMMR/MSS) that often doesn't respond well to immunotherapy alone. The trial combines an immunotherapy drug (serplulimab) with chemotherapy (CAPEOX) and an anti-inflammatory drug (celecoxib) to see if this mix can shrink tumors more effectively before surgery. About 50 adults will take part to measure how many achieve a complete disappearance of cancer cells in the removed tissue.
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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 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Dec 2026
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. Willing and able to provide written informed consent. 2. Male or female subjects ≧ 18 years ≦ 75 of age. 3. Histological or cytological documentation of adenocarcinoma of the rectum. 4. No previous any systemic anticancer therapy for rectal cancer disease. 5. The lower margin of the tumor is less than 10cm from the anus verge. 6. cT2N1-2M0, cT3N0-2M0, cT4N0-2M0 MSS with MRF(-) assessed by MRI. 7. Primary tumor can be detected by CT or MRI. 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 9. Eligible tumor tissues were identified for MSI/MMR assays. 10. Hepatitis B Surface Antigen (HBsAg) (-). 11. If HBsAg (+) , HBV-DNA must be less than 2500 copies/mL or 500 IU/mL to be enrolled. 12. Patients with HCV antibody (-) or HCV-RNA negative can be enrolled. Aspartate aminotransferase (AST) must be ≤ 3 x ULN for the lab. If HCV-RNA is positive, patients with both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) performed ≤3×ULN could be enrolled. Patients infected with both hepatitis B virus and hepatitis C virus should be excluded (positive for HBsAg or HBcAb and positive for HCV antibodies). Exclusion Criteria: 1. Patients with recurrent rectal cancer or a history of pelvic radiotherapy. 2. Patients with a history of inflammatory bowel disease. 3. Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease (HIV1 antibody, HIV2 antibody, HTLV1 antibody positive) should be excluded. 4. Patients who are preparing for or have previously received an organ or bone marrow transplant. 5. History of myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms in women) in the 6 months prior to enrollment (QTc interval calculated by Fridericia formula). 6. According to New York College of Cardiology (NYHA) standards for Grade III-IV cardiac insufficiency or cardiac color ultrasound: left ventricular ejection fraction (LVEF) \<50%.Poor hypertension control (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy. 7. Poor hypertension control (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy. 8. Patients had undergone major surgery within 28 days prior to enrollment. Patients with tumor biopsy or lymph node dissection biopsy were admitted. Patients undergoing enterostomy due to intestinal obstruction were admitted. 9. The patients had previously been treated with other antibodies/drugs that target immune checkpoints, such as PD-1, PD-L1, and cytotoxic T lymphocyte-associated Antigen 4 (CTLA-4). 10. Patients are participating in other clinical studies, or plan to start this study treatment less than 14 days from the end of the previous clinical study. 11. Uncontrolled tumor-related pain. 12. A known history of severe allergy to any monoclonal antibody. 13. Known to be allergic or intolerance to any oxaliplatin and capecitabine ingredients. 14. Pregnant or lactating women. 15. The investigators determined that the patient had other factors that might have led to the early termination of the study.
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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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Second Affiliated Hospital School of Medicine Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310000, China
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Other studies related to the condition(s) this trial covers.
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- Can diet and vitamin c supercharge rectal cancer treatment?
- Can a Triple-Drug rechallenge tame colorectal cancer?
- New cocktail approach aims to wipe out High-Risk rectal cancer without surgery
- Intermittent fasting tested to ease radiation side effects in cancer patients
- New adaptive radiation boosts rectal cancer response rates