colorectal cancer
Conditions
Interventions
1:cetuximab, FOLFIRI combined with NK as the second line remedy
Sponsors
the Affiliated Xinqiao Hospital of the Third Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Man or woman 18~70 years of age; (2) Histologically or cytologically confirmed diagnosis of adenocarcinoma of the colon or rectum; (3) Wild-type (without mutation in codons 12 and 13) KRAS gene in tumor tissue confirmed by a central laboratory; (4) At lest 1 measurable or non-measurable lesion per RECIST version1.1 guidelines.lesion must not be chosen from a previously irradiated field unless there had been documented tumor progression in that lesion prior to randomization.All sites of disease must be evaluated=28days prior to randomization; At lest 1 measurable lesion .The only one lesion,the nature of the new biological lesions must be confirmed by cytology or organization; By any of following methods can at least accurate measurement of single diameter of lesions, chest or abdominal CT scan or MRI, the conventional method of diameter of at least 20mm or application of spiral diameter of at least 10mm; (5) Treatment failure (defined as failure due to either disease progression[clinical or radiological]or toxicity[treatment intolerance]) of a prior regimen containing irinotecan for metastatic disease and a prior regimen containing oxaliplatin for metastatic disease.Oxaliplatin and irinotecan may have been administered sequentially or in combination; Disease relapse within 6 months after completing adjuvant chemotherapy (with either an irinotecan or oxaliplatin containing regimen)will also be considered as treatment failure of a prior regimen for metastatic disease; (6) ECOG performance status of 0-1; (7) Life expectancy =24 weeks; (8) Organ function level must meet the following requirements; Hematologic function: Absolute neutrophil count(ANC)=1.5×10^9/L, platelet count=90×10^9/L, hemoglobin=9g/dL; Hepatic function: bilirubin=1.5×ULN, Aspartate aminotransferase(AST)and Alanine aminotransferase(ALT)=2.5×ULN (if liver metastases AST, ALT=5); Renal function: Serum Creatinine =1.5×ULN; NO malabsorption or other gastrointestinal disorders affecting drug absorption; (9) Age in male and female patients entered the trial, in the course of the study until 30 days after drug withdrawal must use reliable methods of contraception, contraceptive method is reliable by the principal investigator or designate personnel to judge; (10) Can understand this trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Symptomatic brain metastases requiring treatment; (2) History of other malignancy, except: Malignancy treated with curative intent and with no known active disease present for=5 yeas prior to randomization and felt to be at low risk for recurrence by the treating physician; Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease. Adequately treated cervical carcinoma in situ without evidence of disease; Prostatic intraepithelial neoplasia without evidence of prostate cancer; (3) Prior anti-EGFR antibody therapy (eg. pantumumab or cetuximab) or treatment with small molecule EGFR inhibitors (eg, gefitinib, erlotinib, lapatinib); (4) Antitumor therapy (eg, chemotherapy, hormonal therapy, immunotherapy, antibody therapy) =6 month before randomization; (5) Before randomization for 14 days or 14 days received radiotherapy; (6) Ever received treatment of NK cells and/or CIK cell therapy; (7) Coronary heat disease, angina, myocardial infarction arrhythmia, cerebral thrombosis,cerebral hemorrhage and other serious heart,cerebrovascular disease patients; (8) There are no easy control of psychiatric history; (9) The investigator considered unsuitable for the study; (10) Immunosuppression after organ transplantation are used for a long time; (11) History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product administration or may interfere with the interpretation of the results; (12) Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolic event = 30 days before randomization. If on anticoagulation, subject must be on stable therapeutic dose prior to randomization; (13) Subject pregnant or breast feeding, or planning to become pregnant during treatment and within 2 months after the end of treatment; (14) Female subject of childbearing potential is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for at least an additional 2 months after the end of treatment; (15) Known positive test(s) for human immunodeficiency virus infection (testing is not required in the absence of clinical suspicion); (16) Active infection requiring systemic treatment or any uncontrolled infection = 14 days prior to randomization (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection); (17) Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures or is unwilling or unable to comply with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate, DCR;Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety of the project;overall survival;progression-free survival; | — |
Countries
China
Contacts
Public ContactZhu bo
the Affiliated Xinqiao Hospital of the Third Military Medical University
Outcome results
None listed