Phase
Condition
Neoplasm Metastasis
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18 - 75 years
Confirmed by pathology (including histology or cytology) as metastatic colorectaladenocarcinoma of the liver (no other metastatic sites)
Confirmed by CT/MRI/PET - CT/ultrasound examination of liver metastases, the livermetastases number 3 or higher, and the multidisciplinary team (MDT) confirmed forunresectable liver metastases;
Patients with at least one evaluable or measurable lesions as per RECIST version 1.1 (CT scan length and diameter of tumor lesion≥10mm,CT scan of lymph node lesion wasshort diameter≥15mm,scan slice thickness 5mm;)
ECOG(Eastern Cooperative Oncology Group)PS(Performance Status):0-2 scores
The expected survival time is more than 3 months
The main organ function is normal, which should meet the following criteria:
(1) blood routine examination standards should be met(no blood transfusion within 14days) a.HB≥ 90g/L b. WBC≥3×109/L c. ANC≥1.5×109/L d. PLT≥100×109/L (2)biochemicalexamination shall comply with the following criteria:
BIL<1.5 normal upper limit ULN
ALT and AST≤5 ULN
Cr≤1.5 ULN,CCR(creatinine clearance rate)≥50ml/min(Cockcroft-Gault formula)
Women of childbearing age must have a pregnancy test in 7 days before entering thegroup (in serum), and the results were negative, and willing to use appropriatecontraception during the study period and the last 8 weeks after giving drug test; menshould have the surgical sterilization, or adopt the appropriate contraceptive methodsduring the test and the last 8 weeks after giving drug test。
Participants is willing to participate in this study, sign the informed consent, havegood compliance, cooperate with follow-up.
Exclusion
Exclusion Criteria:
Participants is willing to participate in this study, sign the informed consent, havegood compliance, cooperate with follow-up.
Any other malignancy was diagnosed within the first 5 years of the study, exceptlocally treatable and cured basal cell or squamous cell carcinoma of the skin,superficial bladder cancer, carcinoma in situ of the cervix, carcinoma in situ of thebreast duct, and papillary carcinoma of the thyroid.
Patients who had received anti-tumor therapy, including chemotherapy, radiotherapy,surgery, endocrine therapy, biological therapy, tumor embolization, targeted therapyand immunotherapy (pd-1 / pd-l1 antibody, anti-pd-l2 antibody, anti-cd137 antibody,ctla-4 antibody, or other drugs/antibodies acting on T cell co-stimulation orcheckpoint pathway) within 28 days before enrollment.
Accompanied by serious heart, lung, liver, kidney disease; Have nerve, mental disease;obstruction of the digestive tract with severe infection.
Distant metastases to sites other than the liver.
The blood pressure of patients with hypertension cannot be reduced to the normal rangeby the antihypertensive drugs (systolic pressure >140 mmHg, diastolic pressure >90mmHg)
Patients have a clear tendency with gastrointestinal bleeding, including the followingsituation: local active ulcerative lesions, and fecal occult blood (+ +); with melenaand hematemesis history in 2 months; and patients with fecal occult blood (+) andunresected gastric primary tumor; patients with the risk of bleeding should take thegastroscopy test, if it is the gastric cancer, and researchers believe that mayresults in massive digestive tract hemorrhage;coagulation dysfunction (INR(international normalized ratio)>1.5, APTT(activated partial thromboplastintime)>1.5 ULN), with bleeding tendency
pregnant or lactating women
A history of immunodeficiency, including HIV testing positive, or other acquired orcongenital immunodeficiency disorders, or a history of organ transplantation andallogeneic bone marrow transplantation
Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolledsystemic diseases (e.g., diabetes, hypertension, pulmonary fibrosis, and acutepneumonia)
Patients are positive of urine protein (urine protein detection 2+ or above, or 24hours urine protein quantitative >1.0g)
Patients with a history of cardiovascular and cerebrovascular diseases who are stilltaking oral thrombolytic drugs or anticoagulant drugs
Patients with uncontrolled epilepsy, central nervous system disease, or mentaldisorders whose clinical severity, as determined by the investigator, may prevent thesigning of the informed consent or have multiple factors that affect oral medications (such as inability to swallow, persistent uncontrolled nausea and vomiting, chronicdiarrhea, and intestinal obstruction)
A person who has previously been allergic to any component of camrilizumab or to anycomponent of the drug under study
Patients who participate in other clinical studies before or during treatment
The researchers consider those who were not suitable for inclusion
Study Design
Study Description
Connect with a study center
Zhongshan Hospital Xiamen University
Xiamen, Fujian 361000
ChinaActive - Recruiting
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