Locally advanced rectal cancer
Conditions
Interventions
Test group:Commence with short-course pelvic radiotherapy, followed one week after completion of radiotherapy by four cycles of chemotherapy (XELOX) combined with iparolib and toripalimab
iparolib and toripalimab are administered at a dose of 5 mg/kg per dose, every three weeks.
Sponsors
harbin medical university cancer hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Subjects, both male and female, aged 18-70 years (inclusive) at the time of signing the informed consent form; 2.The Eastern Cooperative Oncology Group (ECOG) score is 0 or 1 (see Annex 1); 3.The pathology confirmed it as rectal adenocarcinoma; 4.Baseline clinical staging is T3b or above, with no distant metastasis; 5.Did not receive immunotherapy, targeted therapy, or pelvic radiotherapy before enrollment; 6.The baseline blood routine and biochemical indicators of the subjects met the following criteria: hemoglobin >=90g/L; absolute neutrophil count (ANC) >=1.5×10^9/L; platelets >=100×10^9/L; ALT and AST =30g/L; 7.Capable of providing a signed informed consent form, including compliance with the requirements and restrictions outlined in the Informed Consent Form (ICF) and this protocol.
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant or breastfeeding; 2.Individuals with a history of other malignant tumors in the past 5 years, excluding cured skin cancer and cervical carcinoma in situ; 3.Individuals with uncontrolled epilepsy, central nervous system diseases, or a history of mental disorders, whose clinical severity, as assessed by the investigator, may hinder the signing of informed consent or affect the patient's compliance with oral medications; 4.Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) Class II or more severe congestive heart failure, or severe arrhythmias requiring pharmacological intervention (see Appendix 12), or a history of myocardial infarction within the last 12 months; 5.Individuals requiring immunosuppressive therapy and long-term hormone therapy for organ transplantation; 6.Patients with autoimmune diseases; 7.Individuals with severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; 8.Individuals known to have dihydropyrimidine dehydrogenase (DPD) deficiency; 9.Individuals who are allergic to any of the components of the study medication; 10.Patients who, in the investigator's judgment, are unsuitable for participation in this study due to the presence of other severe physical or mental illnesses, abnormal laboratory test results, or conditions that may increase the risk of participating in the study, affect treatment compliance, or interfere with study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction incidence rate;Progression free survival rate;R0 resection rate;Clinical complete remission rate; | — |
Countries
China
Contacts
Public ContactHan Peng
harbin medical university cancer hospital
Outcome results
None listed