Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence

• Status: Recruiting
• Trial end date: 2025-09-25
• Target enrollment: 0
• Participant gender: All

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 colorectal cancer liver metastasis (CRLM) patients with high risk of locally recurrence. Researchers will compare the combination therapy with the postoperative chemotherapy alone to see if postoperative chemotherapy plus SBRT and immunotherapy can further reduce the risk of recurrence and metastasis after surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Antibodies

Criteria

Inclusion Criteria:

1. age ≥ 18 years old, female and male

2. pathological and imaging confirmed colorectal colorectal liver metastases (synchronous or heterochronous)

3. Metastatic liver lesions <= 5

4. Primary colorectal cancer under control

5. Absence of evidence of extra-hepatic diseases

6. Metastatic liver lesions received resection with insufficient margin (<0.5cm) or R1/R2 resection

7. Karnofsky >= 70

8. Adequate organ function without contraindications to surgery, radiotherapy and immunotherapy

9. Without previous antitumoral immunotherapy

10. With good compliance

11. Signed the inform consent

Exclusion Criteria:

1. Pregnancy or breast-feeding women

2. History of other malignancies within 5 years (except cured skin cancer and cervical cancer in situ)

3. History of uncontrolled epilepsy, central nervous system disease, or psychiatric disorders

4. 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

5. Immunodeficiency disease, autoimmune diseases or long-term using of immunosuppressive agents

6. Severe uncontrolled recurrent infections

7. 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

8. Allergic to any component of the therapy