Primary colon cancer or primary rectal cancer.
Conditions
Interventions
Treatment Group:For tumors with a diameter =5 cm, spatially fractionated radiation therapy is employed. The treatment is delivered on alternate days with a single-fraction dose of 12 Gy (peak dose) an
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily participate in this study, provide written informed consent, are aged between 18 and 75 years (inclusive), with no restriction on sex. 2. Histologically or cytologically confirmed metastatic colorectal adenocarcinoma. 3. Disease progression after at least two prior lines of systemic antitumor therapy for colorectal cancer, including at least first-line and second-line chemotherapy regimens containing fluoropyrimidines, oxaliplatin, and irinotecan. 4. An interval of >=1 month since the last chemotherapy treatment. 5. Karnofsky Performance Status (KPS) >= 80, or Eastern Cooperative Oncology Group (ECOG) performance status of 0–1, with an expected life expectancy >= 3 months. 6. No prior participation in any other clinical trials. 7. Presence of hypertension is permitted if well controlled, with a maximum systolic blood pressure = 2 × 10?/L, platelet count >= 100 × 10?/L, and hemoglobin >= 9 g/dL. 9. Adequate hepatic function: total bilirubin = upper limit of normal (ULN); AST and ALT = 60 mL/min. 11. During the screening period, corrected QT interval (QTcF) <=450 msec for males and <=470 msec for females, with no unhealed wounds present. 12. At least two measurable metastatic lesions according to RECIST version 1.1 prior to enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients with bone marrow suppression associated with a high risk of infection or bleeding. 2. Presence of severe cardiovascular or cerebrovascular diseases. 3. Patients with impaired consciousness, inability to adequately communicate subjective symptoms, or a history of psychiatric disorders. 4. Active autoimmune diseases or ongoing immunosuppressive therapy. 5. Prior treatment with any anti-angiogenic small-molecule targeted agents or immune checkpoint inhibitors for any indication. 6. Receipt of local radiotherapy within 6 months prior to screening. 7. Presence of active infection within the planned radiotherapy field or a high risk of gastrointestinal perforation in the irradiation area. 8. Patients meeting any of the following conditions: * Positive hepatitis C virus (HCV) antibody with detectable or elevated HCV-RNA levels; * Positive hepatitis B surface antigen (HBsAg) with elevated HBV-DNA levels; * Liver cirrhosis; * Positive HIV antibody; * Positive syphilis serology. 9. Any other condition that, in the investigator’s judgment, renders the subject unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective relief rate;Overall Survival;Disease Control Rate;safety; | — |
Countries
China
Contacts
Public ContactLiyang Wang
Sichuan Cancer Hospital
Outcome results
None listed