| Eligibility |
Inclusion Criteria:
- Age =18 years old and =75 years old
- Histologically confirmed colorectal adenocarcinoma
- Radiologically and/or pathologically confirmed liver metastasis
- Immunohistochemistry and/or genetic testing confirmed pMMR/MSS
- Absence of extrahepatic metastasis confirmed by CT, MRI or PET/CT (if necessary)
- Primary lesion has been or can be removed by radical surgery
- Liver metastases can be resected (or using intraoperative radiofrequency) and is
expected to achieve tumor-free status (NED) after surgery. Resectable liver metastases
are defined explicitly as ? less than 5 metastatic lesions; ? R0 resection is
achievable by resection or intraoperative radiofrequency; ? Remaining liver volume is
expected to be sufficient after surgery; ? The following can be retained after
resection: One hepatic vein, preserve blood flow in and out of the remaining liver,
the bile duct, and at least 2 adjacent livers segments ? There is no extrahepatic
metastasis.
- Apart from surgical resection of the primary lesion, he/she has not received any
anti-tumor treatment for liver metastasis (including chemotherapy, targeted drugs,
interventional therapy, immunotherapy, radiotherapy, etc.)
- Normal hematological function (platelets>90×109/L; white blood cells>3×109/L;
neutrophils>1.5×109/L)
- Serum bilirubin = 1.5 times the upper limit of normal (ULN), transaminase = 5 times
ULN, alkaline phosphatase =2.5 ULN, No ascites, normal coagulation function, albumin
=35g/L
- Child-Pugh classification of the liver is A
- Serum creatinine is less than the upper limit of normal (ULN), or the calculated
creatinine clearance rate is greater than 50ml/min (using Cockcroft-Gault formula)
- ECOG score 0-1
- Life expectancy> 3 months
- Signed and written informed consent
- Willing and able to follow up until death or the end of the study or the study is
terminated
Exclusion Criteria:
- Presence of distant metastases outside the liver after the diagnosis of colorectal
cancer
- Liver metastases have been treated with chemotherapy, targeted drugs, intervention,
immunotherapy, radiotherapy, etc.
- No surgical resection plan for liver metastases
- Received oxaliplatin-containing adjuvant chemotherapy in the past 1 year
- Any residual toxicity from previous chemotherapy (except for hair loss), such as
peripheral neuropathy =NCI CTC v3.0 Grade 2
- Use of immunosuppressive drugs within 1 week before treatment, not including nasal
sprays, inhalation or other local treatments, partial glucocorticoids or physiological
doses of systemic glucocorticoids (i.e. not more than 10 mg/day prednisone or
equivalent doses of other glucocorticoids) or use of corticoids to prevent contrast
agent allergy
- Suffering from interstitial lung disease that requires steroid therapy
- Medical history of active autoimmune disease that needs symptomatic treatment within
the past 2 years. Vitiligo, psoriasis, hair loss, or Grave's disease that do not
require systemic treatment within the past 2 years, or hypothyroidism patients that
only need thyroid hormone replacement therapy and type I diabetic patients requiring
only insulin replacement therapy can be enrolled
- History of primary immunodeficiency
- Active tuberculosis
- Known history of allergies related to organ transplantation or hematopoietic stem cell
transplantation
- Allergic to any monoclonal antibody or chemotherapeutic drug (fluorouracil,
oxaliplatin) and its ingredients
- Have bleeding tendency or coagulopathy
- Patients with apparent symptoms of intestinal obstruction
- Hypertensive crisis or hypertensive encephalopathy
- Serious uncontrollable systemic complications such as infection or diabetes
- Clinically severe cardiovascular diseases such as cerebrovascular accident (within 6
months before enrollment), myocardial infarction (enrollment within the first 6
months), uncontrollable hypertension, unstable angina pectoris, heart failure (NYHA
2-4), arrhythmia requiring medical treatment
- Presence of central nervous system disease ( such as primary brain tumor, history of
uncontrollable epilepsy, any brain metastases or stroke)
- Suffered from other malignant tumors in the past 5 years (except resected skin basal
cell carcinoma and/or cervical carcinoma in situ)
- Received any drug treatment used for this study in the last 28 days
- Women who are pregnant and breastfeeding. Women of childbearing age who do not use or
refuse to use effective non-hormonal contraceptive methods (intrauterine contraceptive
ring, barrier contraception combined with spermicidal gel or female sterilization )
(<2 years after the last menstruation) or men with childbearing potential who are
unable or unwilling to comply with the research protocol
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