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Trial Title:
Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence
NCT ID:
NCT06120127
Condition:
Radiotherapy
Immunotherapy
Liver Metastases
Colorectal Cancer
Conditions: Official terms:
Neoplasm Metastasis
Liver Neoplasms
Recurrence
Antibodies
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
adjuvant radiotherapy: SBRT; immunotherapy: sintilimab chemotherapy: XELOX
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT
Description:
postoperative SBRT of liver lesions
Arm group label:
chemotherapy with radiotherapy and immunotherapy
Other name:
radiotherapy
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
XELOX/FOLFOX/FOLFIRI
Arm group label:
chemotherapy
Arm group label:
chemotherapy with radiotherapy and immunotherapy
Intervention type:
Drug
Intervention name:
PD-1 antibody
Description:
Sintilimab (200mg d1，q3w)
Arm group label:
chemotherapy with radiotherapy and immunotherapy
Other name:
Sintilimab
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.
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, more than 50% of patients will experience recurrence within 2 years
after resection of liver metastases. SBRT can be an effective and safe treatment
modality, which can not only provide better local control of metastatic lesions, but also
has a sensitizing immunotherapeutic effect. SBRT can effectively synergize with
anti-PD-1/PD-L1 antibodies to activate the immune microenvironment of CRLM patients and
improve survival. However, in CRLM patients after surgery, whether combining SBRT,
immunotherapy and adjuvant chemotherapy results in better survival than chemotherapy
alone, the evidence is insufficient.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Xia Fan, M.D, PH.D
Phone:
13564676623
Email:
tcxiafan@hotmail.com
Start date:
September 25, 2023
Completion date:
September 25, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06120127
