MSS/pMMR Locally Advanced Rectal Cancer
Conditions
Interventions
Experimental Group:Ong-Course Radiotherapy Combined with Ipilimumab, Bevacizumab, and Capecitabine
Sponsors
West Southwest Medical University Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation in this clinical study, understanding of the study procedures, and ability to provide written informed consent; 2.Age 18–75 years (inclusive) at the time of signing the informed consent form, male or female; 3.ECOG Performance Status (PS) score of 0–1; 4.Histologically confirmed rectal adenocarcinoma (cT3–4N0M0 or cTxN+M0, stage II–III, 8th edition of AJCC staging system); 5.Distance from the inferior edge of the tumor to the anal verge = 10 cm; 6.Immunohistochemical (IHC) staining of biopsy tissue demonstrating mismatch repair proficient (pMMR) status (i.e., positive expression of MSH1, MSH2, MSH6, and PMS2), or genetic testing indicating microsatellite stable (MSS) / microsatellite instability-low (MSI-L); 7.No prior surgery (except palliative stoma), radiotherapy, chemotherapy, targeted therapy, immunotherapy, or other anti-tumor treatment; 8.Adequate organ function meeting the following criteria (no blood products or colony-stimulating factors allowed within 2 weeks before initiation of study treatment): (1) Hematology: 1)Absolute neutrophil count (ANC) >=1.5×10^9/L; 2)Hemoglobin (Hb) >=9g/dL; 3)Platelet count (PLT)>=100×10^9/L; 4)Serum albumin (ALB)>=2.8 g/dL. (2) Blood chemistry: 1)Total bilirubin (TBIL)=50 mL/min (calculated by the Cockcroft-Gault formula); 4)Normal thyroid function. 9.Life expectancy >= 3 months; 10.Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours before the first dose of study treatment, and agree to use effective contraception during the study and for 3 months after the last dose of the Ato combination antibody. Male subjects whose partners are women of childbearing potential must agree to use effective contraception during the study and for 3 months after the last dose of the Ato combination antibody.
Exclusion criteria
Exclusion criteria: 1.Colorectal cancer (CRC) with microsatellite instability-high (MSI-H) or deficient mismatch repair (dMMR) status; 2.Positive HBsAg with HBV DNA > ULN (10,000 copies/mL or 2,000 IU/mL); or positive HCV (acute or chronic infection confirmed by HCV RNA or HCV Ab); or known HIV-positive status or AIDS; 3.Any active or history of autoimmune disease, including but not limited to interstitial lung disease, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism (hypothyroidism is allowed if normalized by hormone replacement therapy); 4.Subjects with a severe infection within 4 weeks before the first dose, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia; subjects with any active infection are excluded; 5.History of another malignancy within 5 years before screening, except adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery (hormonal therapy for non-metastatic prostate or breast cancer is allowed), and papillary thyroid cancer; 6.History of pelvic or abdominal radiotherapy; 7.Conditions impairing oral drug absorption, including inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.; 8.Multiple primary colorectal cancers; 9.Known or suspected hypersensitivity to any study drug or any related medication used in this trial; 10.Any other condition judged by the investigator that may force premature discontinuation from the study, including serious concomitant diseases (including psychiatric disorders), severely abnormal laboratory values, family or social factors precluding long-term follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response,pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life;Disease-Free Survival;Tumor Regression Grade,TRG;Safety;Overall Survival;Objective response rate,ORR;Disease Control Rate; | — |
Countries
China
Contacts
Public ContactYuhao Luo
West Southwest Medical University Affiliated Hospital
Outcome results
None listed