rectal cancer
Conditions
Interventions
Experimental group:Neoadjuvant long course radiotherapy with trifluridine and tepiracil
Sponsors
Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before enrollment; 2. No gender limit, aged 18-75 years; 3. Rectal adenocarcinoma was confirmed histologically with the following conditions: (1) Stage II (T3-4, N-) or Stage III (any T, N+) was defined based on MRI; (2) The tumor was less than 12cm from the anal margin; 4. Complete chest and abdominal CT or whole body PET-CT examination to exclude distant metastasis; 5. No history of invasive rectal malignancy; 6. No other rectal cancer (sarcoma, lymphoma, carcinoid, squamous cell carcinoma, etc.) or synchronous colon cancer; 7. Measurable lesions that meet RECIST v1.1 standards for evaluation; 8. ECOG score 0-1; 9. Life expectancy > 6 months; 10. Non-surgical sterilization or female patients of reproductive age who are required to use a medically approved contraceptive (such as an intrauterine device, contraceptive pill or condom) during the study treatment period and for 3 months after the study treatment period ends; Female patients of childbearing age who were not surgically sterilized must have a negative serum or urine HCG test within 7 days prior to study enrollment; And must be non-lactation period; Male patients of non-surgical sterilization or reproductive age are required to consent to use a medically approved contraceptive method with their spouse during the study treatment period and for 3 months after the study treatment period ends; 11. The functions of vital organs meet the following requirements (excluding the use of any blood components and cell growth factors within 14 days) : (1) The standard of blood routine examination shall meet (no blood transfusion or blood products within 14 days) : ANC>=1.5x10^9/L; PLT>=80x10^9/L; Hb>=5.6 mmol/L (9g/dL); (2) Biochemical examination should meet the following criteria: TBIL 60ml/min (Cockcroft-Gault formula); 12. The subjects voluntarily participated in the study with good compliance and safety and survival follow-up.
Exclusion criteria
Exclusion criteria: 1. Subject has any active autoimmune disease or history of autoimmune disease (e.g., but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects who had vitiligo or had complete remission of asthma in childhood could be included without any intervention as adults; Subjects with asthma requiring medical intervention with bronchodilators are not included); 2. Subjects who were on immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/ day prednisone or other therapeutic hormone) and continued to use within 2 weeks prior to enrollment; 3. Severe allergic reaction to other monoclonal antibodies; 4. The subject has clinical symptoms of central nervous system metastasis (e.g. brain edema, need for hormonal intervention, or progression of brain metastasis). Subjects who had previously received brain or meninges metastases, such as clinically stable (MRI) for at least 1 month, and who had stopped systemic sex hormone therapy (dose >10mg/ day prednisone or other therapeutic hormone) for at least 2 weeks were enrolled; 5. Clinical symptoms or diseases of heart that are not well controlled, such as: (1) heart failure of NYHA2 or higher, (2) unstable angina pectoris, (3) past myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, (5) QTc>450ms (male); QTc>470ms (female); 6. Abnormal coagulation function (INR>1.5 or PT>16s), bleeding tendency or receiving thrombolytic or anticoagulant therapy; 7. Subjects who had previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy, and were less than 4 weeks prior to the completion of treatment (last dose) (or five half-lives, whichever is longer); Subjects whose adverse events (except alopecia) caused by previous treatment do not recover to 38.5 ? during screening and prior to initial administration; 12. Subjects with previous or current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function; 13. Subjects with congenital or acquired immune deficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA test value exceeds the upper limit of normal value; Hepatitis C reference: HCV virus titer or RNA test value exceeds the upper limit of normal); 14. Subjects who have used other drugs in clinical trials or similar therapeutic drugs within 4 weeks before the first medication; 15. Subject has had or co-has other malignancies (other than cured basal cell carcinoma of the skin and carcinoma in situ of the cerv
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;Security; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYue Jinbo
Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Hospital)
Outcome results
None listed