Multiple primary tumors
Conditions
Interventions
Case series:KN035
Sponsors
Renji Hospital Affiliated to Medical School of Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Sign informed consent; 2. Male or female, aged 18 to 65 years; 3. Patients with multiple primary malignant tumors diagnosed by histopathology (diagnostic criteria: the diagnosis of every malignant tumor is confirmed by tissue/cytology; The pathological diagnosis of every malignant tumor has its unique pathological morphology support, which is different from other diagnoses.The original location of diagnosis of every malignant tumor of gronella occurred in different locations, and no two diagnoses were continuous with each other. One of the diagnoses must be primary colorectal cancer;(except for colorectal cancer, other tumors do not need to receive anti-tumor treatment); 4. Currently suffering from colorectal cancer with distant metastasis; 5. Received second-line or above treatment in the past, and the disease progression was determined by imaging;Or cannot tolerate any line treatment (including adjuvant or first-line treatment, etc.); 6. At least one measurable lesion (RECIST 1.1 standard); 7. Score 0 or 1 in ECOG; 8. The expected survival time is greater than or equal to 12 weeks; 9. Adequate organ and bone marrow function (no hematopoietic growth factor, blood transfusion or platelet therapy was given within 1 week before the first study drug treatment): (1) Blood routine: white blood cells greater than or equal to 3.0x10^9/L, neutrophils greater than or equal to 1.5x10^9/L, platelets greater than or equal to 75x10^9/L, and hemoglobin greater than or equal to 9.0g /dL; Liver function: total bilirubin is less than 1.5 times ULN;When there is no liver metastasis, ALT/AST is no more than 2.5 times ULN.ALT/AST was less than or equal to 5 times ULN in liver metastasis. Kidney function: serum creatinine is no more than 1.5 x ULN; (2). Left ventricular ejection fraction (LVEF) detected by cardiac ultrasound is greater than or equal to 50%; 10. Women of reproductive age who have a negative pregnancy test and are willing to take effective contraception during the study period; 11. Informed consent has been fully understood and signed voluntarily.
Exclusion criteria
Exclusion criteria: 1. Participate in clinical trials of other research drugs within 30 days before the first study of drug treatment;Or received anti-tumor therapy within 2 weeks, including but not limited to chemotherapy, radiotherapy, targeted therapy, etc.The toxicity of anti-tumor therapy has not yet recovered to the level 0 or 1 (the peripheral neurotoxicity caused by hair loss and chemotherapy can be listed at level 2); 2. Previous treatment with checkpoint drugs; 3. Performed major surgical operations (except biopsy) within 4 weeks before the first study of drug treatment or the surgical incision was not completely healed; 4. During the 2 weeks before the first study of drug treatment, there was a progressive increase in thoracic/ascites conservative treatment or pericardial effusion; 5. Active brain metastasis or spinal cord compression;For patients with brain metastasis who have received previous treatment, if the clinical condition is stable within 4 weeks before the first study drug treatment and the imaging evidence does not show the disease progression, and there is no need to receive corticosteroid treatment within 2 weeks before the first study drug treatment, they can be considered into the group; 6. Active, known or suspected autoimmune diseases (patients with vitiligo who do not need systemic treatment within 2 years before the first study of drug treatment are allowed to be included;Patients with hypothyroidism requiring only thyroid hormone replacement therapy and type I diabetes requiring only insulin replacement therapy, as well as pituitary inflammation and adrenocortical insufficiency requiring only physiological hormone replacement therapy can be included); 7. Patients with HIV infection; 8. Active bacterial or fungal infections requiring treatment within 14 days before the first study of drug therapy; 9. Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia, symptomatic interstitial lung disease or any evidence of active pneumonia on chest CT scan within 4 weeks before the first study of drug treatment; 10. During the screening period, HBV DNA was greater than or equal to 2000 IU/ml (or 104 copies /ml); Note: for the selected anti-hbc (+)/HBsAg (+)/HBV DNA IU/ml or anti-hbc (+)/HBsAg (-)/HBV DNA 2,000 IU/ml subjects must receive antivirus treatment simultaneously during the trial. The original drug or entecavir can be used.For enrolled HCV rna-positive subjects, it was up to the researchers to decide whether they should also receive antiviral therapy; 11. Cardiovascular diseases with significant clinical significance, including, but not limited to, acute myocardial infarction, severe/unstable angina pectoris, cerebrovascular accident or transient ischemic attack, and congestive heart failure (grade 2 of the New York heart association) within the first 6 months of enrollment;Arrhythmias that require other anti-arrhythmia drugs in addition to beta beta blockers or digoxin;Ecg repetition detection QTcF interphase > 450 milliseconds (ms);Hypertension (systolic blood pressure >150mmHg, diastolic blood pressure > 100mmhg) not well controlled after antihypertensive therapy; 12. Thyroid dysfunction exists, and thyroid function cannot be maintained in the normal range by use of drugs; 13. Abnormal serum electrolyte levels with clinical significance; 14. Immunosuppressive drugs were used within 2 weeks before the first study of drug therapy, excluding local glucocorticoid o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| remission rate; | — |
Countries
China
Contacts
Public ContactHaiyan Yang
Renji Hospital Affiliated to Medical School of Shanghai Jiaotong University
Outcome results
None listed