Colorectal cancer
Conditions
Interventions
Experimental group:Hypofractionated radiotherapy followed by sequential iparolizumab combined with trifluridine-tipiracil and bevacizumab
Sponsors
Jiangxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to implementation of any trial-related procedures; 2. Male or female>=18 years old, 3 months; 7. At least 1 measurable lesion according to the RECIST1.1 criterion; 8. No previous history of radiotherapy or no overlap between the location of the second course of radiotherapy and the original radiotherapy site; 9. All acute toxic reactions caused by prior anti-tumor therapy have resolved to grade 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level for inclusion/exclusion criteria; 10. Adequate organ function: WBC>=3.0*10^9/L, PLT>=50*10^9/L, Hgb>=80*10^9/L; ALT=28g/L; CCr>=80ml/min; 11. Women of childbearing potential (WOCBP) with a negative pregnancy test (urine or blood) and agree to use an effective method of contraception. Women of childbearing potential are people who are biologically capable of becoming pregnant. Reliable contraception must be used consistently from trial screening;
Exclusion criteria
Exclusion criteria: 1. Pleural effusion, ascites, pericardial effusion with clinical symptoms requiring drainage; 2. Central nervous system metastases; 3. Those with severe dysfunction of important organs (heart, liver, kidney); 4. Known hypersensitivity or anaphylactic reaction to any component of the study treatment; 5. Previous history of organ transplantation or autologous/allogeneic stem cell transplantation; 6. Receiving hormone therapy other than chronic systemic immunotherapy or physiological replacement therapy; 7. Any unstable systemic disease: active infection, uncontrolled severe hypertension, unstable angina, angina pectoris that started in the last 3 months, congestive failure (New York Heart Association [NYHA]>=Class II.), myocardial infarction within 6 months before enrollment, severe arrhythmia requiring medication, gastrointestinal bleeding or active bleeding tendency within 1 month; 8. Combined with other uncured malignant tumors, except carcinoma in situ in other parts; 9. Any disease, metabolic disorder, or physical examination or laboratory suspicion that the patient has contraindications to the study drug or has high-risk factors for treatment complications; 10. Received treatment from other clinical trials or is undergoing another clinical study within 4 weeks before the first dose; 11. Received other local treatments for colorectal cancer except radiotherapy within 2 weeks before the first dose; 12. The patient cannot lie flat, or cannot lie flat for 10-20 minutes with radiotherapy; 13. Pregnancy or lactation; 14. Subjects who may have other adverse health conditions or mental states that may affect protocol compliance and evaluation of trial indicators in the opinion of the investigator, and are not suitable to participate in the study;
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Disease symptoms and health-related quality of life;Safety evaluation;Duration of remission;Disease control rate;No time to progression;Total survival; | — |
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactZhong Xiaoming
Jiangxi Cancer Hospital
Outcome results
None listed