Status:
UNKNOWN
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence
Lead Sponsor:
Fudan University
Conditions:
Radiotherapy
Immunotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a randomized controlled phase II trial to evaluate the efficacy of the combination of stereotactic body radiation therapy (SBRT) and immunotherapy with postoperative chemotherapy in colo...
Detailed Description
40-50% of colorectal cancer patients have metastases at the time of diagnosis, of which liver metastases are the most common. Surgical resection is the most likely cure for CRLM patients, however, mor...
Eligibility Criteria
Inclusion
- age ≥ 18 years old, female and male
- pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous)
- Metastatic liver lesions \<= 5
- Primary colorectal cancer under control
- Absence of evidence of extra-hepatic diseases
- Metastatic liver lesions received resection with insufficient margin (\<0.5cm) or R1/R2 resection
- Karnofsky \>= 70
- Adequate organ function without contraindications to surgery, radiotherapy and immunotherapy
- Without previous antitumoral immunotherapy
- With good compliance
- Signed the inform consent
Exclusion
- Pregnancy or breast-feeding women
- History of other malignancies within 5 years (except cured skin cancer and cervical cancer in situ)
- History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders
- Clinically serious heart disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacologic intervention, or history of myocardial infarction within the last 12 months
- Immunodeficiency disease, autoimmune diseases or long-term using of immunosuppressive agents
- Severe uncontrolled recurrent infections
- Baseline blood and biochemical indicator do not meet the following criteria: neutrophils \>=1.5×10\^9/L, Hb \>=90g/L, PLT \>=100×10\^9/L, ALT/AST\<=2.5 ULN, Cr \<= 1ULN
- Allergic to any component of the therapy
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06120127
Start Date
September 25 2023
End Date
September 25 2025
Last Update
November 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032