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Trial Title:
Serplulimab Combined With CAPEOX + Celecoxib as Neoadjuvant Treatment for Locally Advanced Rectal Cancer
NCT ID:
NCT05731726
Condition:
pMMR
MSS
MSI-L
Locally Advanced Rectal Carcinoma
Conditions: Official terms:
Rectal Neoplasms
Celecoxib
Capecitabine
Oxaliplatin
Conditions: Keywords:
Rectal cancer
Serplulimab
Celecoxib
CAPEOX
neoadjuvant therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Serplilumab
Description:
Serplilumab is an innovative monoclonal antibody targeting PD-1, developed by Shanghai
Henlius Biotech, Inc.
300 mg, q3w
Arm group label:
Serplulimab+CAPEOX+celecoxib
Other name:
HLX10
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Given PO
Arm group label:
Serplulimab+CAPEOX+celecoxib
Other name:
Xeloda
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Given IV
Arm group label:
Serplulimab+CAPEOX+celecoxib
Other name:
OHP
Intervention type:
Drug
Intervention name:
Celecoxib
Description:
celebrex
Arm group label:
Serplulimab+CAPEOX+celecoxib
Other name:
Given PO
Summary:
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. Chemotherapy, such as CAPEOX regimen,
work in different ways to stop the growth of tumor cells, either by killing the cells, by
stopping them from dividing, or by stopping them from spreading. Celecoxib, a COX-2
inhibitor, can improve the immune microenvironment and have a potential to synergy with
immunotherapy. Chemotherapy can improve the immunogenicity of cancer cells that might
enhance the efficacy of immunotherapy. The aim of this study is to explore whether
chemotherapy and cyclooxygenase (COX) inhibitors combined with anti-PD-1 monoclonal
antibody (mAb) could improve efficacy for resectable colorectal cancer patient with the
pMMR/MSS phenotype.
Criteria for eligibility:
Criteria:
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. cT3N1M0, T4N0-1M0 MSS.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
8. At least one measurable lesion was evaluated according to RECIST 1.1.
9. Eligible tumor tissues were identified for MSI/MMR assays.
10. Expected survival of at least 3 months.
11. Hepatitis B Surface Antigen (HBsAg) (-) and Hepatitis B Core Antibody (HBcAb) (-).
If HBsAg (+) or HBcAb (+), 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 randomization (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.
Patients with active tuberculosis.
7. 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).
8. 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.
9. Uncontrolled tumor-related pain.
11.A known history of severe allergy to any monoclonal antibody. 12.Known to be allergic
to any oxaliplatin and capecitabine ingredients. 13.Pregnant or lactating women. 14.The
investigators determined that the patient had other factors that might have led to the
early termination of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital School of Medicine Zhejiang University
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinjie He, Doctor
Phone:
+86 13588425440
Email:
hjj18279@163.com
Investigator:
Last name:
Kefeng Ding, Doctor
Email:
Principal Investigator
Start date:
February 22, 2023
Completion date:
February 20, 2025
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05731726
