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

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

Chemotherapy, PD-1 antibody

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Trial in China, for patients who are having surgery for colorectal cancer liver metastasis.
with/without radiotherapy (SBRT} and immunotherapy
The study will how post-operation chemotherapy (the standard of care) works compared to the combination of radiation, immunotherapy (sintilimab, anti PD-1) and chemotherapy (experimental).

Location Location Status
China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
Recruiting

Contacts

Fan Xia, M.D, PH.D
Contact
13564676623 tcxiafan@hotmail.com

Inclusion Criteria

Inclusion Criteria:

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 (= 70
Adequate organ function without contraindications to surgery, radiotherapy and immunotherapy
Without previous antitumoral immunotherapy
With good compliance
Signed the inform consent

Exclusion Criteria

Exclusion Criteria:

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

NCT ID

NCT06120127

Date Trial Added

2023-11-07

Updated Date

2023-11-07