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New treatment option for pMMR
Official title Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT05731726
What this study is testing
What is Serplulimab?
Serplulimab is an investigational medicine, being studied as a potential treatment for pmmr.
Also referred to as HLX10.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Colorectal cancer of Mismatch Repair-proficient (pMMR)/ Microsatellite Stability (MSS) accounts for approximately 85% of all colorectal cancer patients, which might be insensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Willing and able to provide written informed consent.
- Male or female people ≧ 18 years ≦ 75 of age.
- Histological or cytological documentation of adenocarcinoma of the rectum.
- No previous any systemic anticancer therapy for rectal cancer disease.
- The lower margin of the tumor is less than 10cm from the anus verge.
You likely can't join if
- Patients with recurrent rectal cancer or a history of pelvic radiotherapy.
- Patients with a history of inflammatory bowel disease.
- Patients with acquired immunodeficiency syndrome (AIDS-related illnesses) or known human immunodeficiency virus (HIV) disease (HIV1 antibody, HIV2...
- Patients who are preparing for or have previously received an organ or bone marrow transplant.
- History of myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥470 ms in women) in the 6 months prior to enrollment (QTc...
- According to New York College of Cardiology (NYHA) standards for Grade III-IV cardiac insufficiency or cardiac color ultrasound: left ventricular...
See the full eligibility criteria
- Willing and able to provide written informed consent.
- Male or female people ≧ 18 years ≦ 75 of age.
- Histological or cytological documentation of adenocarcinoma of the rectum.
- No previous any systemic anticancer therapy for rectal cancer disease.
- The lower margin of the tumor is less than 10cm from the anus verge.
- cT2N1-2M0, cT3N0-2M0, cT4N0-2M0 MSS with MRF(-) assessed by MRI.
- Primary tumor can be detected by CT or MRI.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Eligible tumor tissues were identified for MSI/MMR assays.
- Hepatitis B Surface Antigen (HBsAg) (-).
- If HBsAg (+) , HBV-DNA must be less than 2500 copies/mL or 500 IU/mL to be enrolled.
- 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...
- Patients with recurrent rectal cancer or a history of pelvic radiotherapy.
- Patients with a history of inflammatory bowel disease.
- 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.
- Patients who are preparing for or have previously received an organ or bone marrow transplant.
- 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).
- 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...
- Poor hypertension control (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg), a past hypertensive crisis or hypertensive encephalopathy.
- 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...
- 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).
- 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.
- Uncontrolled tumor-related pain.
- A known history of severe allergy to any monoclonal antibody.
- Known to be allergic or intolerance to any oxaliplatin and capecitabine ingredients.
- Pregnant or lactating women.
- The investigators determined that the patient had other factors that might have led to the early termination of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.