Rectal cancer
Conditions
Interventions
Neoadjuvant therapy for locally advanced rectal cancer:Serplulimab combined with chemoradiotherapy
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–75 years. 2.Histologically confirmed pMMR/MSS rectal adenocarcinoma via primary tumor biopsy; 3.Treatment-naive patients with preoperative clinical stage cT3-4/N+M0 rectal cancer (AJCC 8th edition), who are not suitable for curative-intent initial local excision. 4.Early-stage disease, but the lesion is less than 5 cm from the anal verge, or direct sphincter-preserving surgery is deemed unfeasible upon surgical evaluation. 5.Strong desire for sphincter preservation and willingness to undergo intensive monitoring for at least 2 years after chemoradiotherapy. 6.Patients who agree to undergo radical surgery and are assessed by surgeons to have no contraindications to surgery; 7.No concurrent multiple primary carcinomas. 8.Having at least one measurable or evaluable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). 9.Expected survival time >= 3 months. 10.Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 to 1. Good compliance and signed informed consent. 11.Good compliance with treatment, and informed consent obtained;
Exclusion criteria
Exclusion criteria: 1.Complete remission is considered difficult to achieve based on current evidence, including: maximum tumor diameter > 10 cm; maximum lateral lymph node diameter > 2 cm; baseline CEA = 100; signet ring cell carcinoma component present in biopsy pathology; circumferential tumor detected on digital rectal examination. 2.Patients with dMMR/MSI-H rectal cancer; 3.Active, known or suspected autoimmune diseases; 4.History of known primary immunodeficiency; 5.History of prior allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 6.Female patients who are pregnant or breastfeeding; 7.Patients complicated with intestinal perforation, intestinal bleeding or other conditions requiring emergency surgery; 8.Uncontrolled concomitant diseases, including but not limited to: HIV-infected individuals (HIV antibody positive) Severe active infections or infections with poor clinical control Patients with active hepatitis Evidence of severe or uncontrolled systemic diseases, such as severe psychiatric or neurological disorders, epilepsy or dementia; unstable or decompensated respiratory, cardiovascular, hepatic or renal diseases; uncontrolled hypertension (defined as hypertension of CTCAE Grade 2 or higher despite pharmacological treatment) Patients with active bleeding or newly-onset thrombotic diseases receiving therapeutic doses of anticoagulants, or those with bleeding tendency and abnormal coagulation function (INR > 1.5×ULN, APTT > 1.5×ULN); 9.Subjects whose baseline blood routine and biochemical parameters fail to meet the following criteria: hemoglobin = 80 g/L; absolute neutrophil count (ANC) = 1.5×10?/L; platelet = 80×10?/L; ALT and AST = 2.5 times the upper limit of normal (ULN); ALP = 2.5 times ULN; total serum bilirubin < 1.5 times ULN; serum creatinine < 1 times ULN. 10.Patients with allergy to any component of the study drug; 11.Currently participating in other clinical trials of investigational drugs; 12.Other patients deemed ineligible for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical complete response (cCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate;R0 resection rate;Safety;3-year disease-free survival rate; | — |
Countries
China
Contacts
Public ContactJiang Su
Suzhou Municipal Hospital
Outcome results
None listed