pancreatic cancer
Conditions
Interventions
Trial Group:Personalized postoperative chemotherapy based on genetic features
Control Group:Traditional postoperative chemotherapy
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must confirmed pancreatic cancer undergoing radical operation; 2. Aged 18 to 75 years; 3. Patients who undergo genetic testing and receive personalized adjuvant therapy must have a complete postoperative pathological specimen, and the amount of sample should be able to meet the requirements of DNA and RNA extraction and quality control; 4. Life expectancy =12 weeks; 5. Karnofsky > 60,ECOG PS 0-2; 6. Patients must have normal organ as defined below,Hemotology: absolute neutrophil count (ANC) =1.5×10^9/L; platelet count=80×10^9/L; hemoglobin concentration = 9.0 g/dL(permit to maintain hemotologic criteria by blood transfusion); Liver Function: TBil =1.5*ULN; ALT and AST =2.5*ULN; AST and ALT for the presence of liver metastases =5*ULN Renal Function: Cr =1.25*ULN, and Ccr =60ml/min; 7. Patients must comply with study protocol and procedure; 8. Patients must have the ability to understand and the willingness to sign a written informed consent document.;Inclusion criteria: 1. Patients must confirmed pancreatic cancer undergoing radical operation; 2. Aged 18 to 75 years; 3. Patients who undergo genetic testing and receive personalized adjuvant therapy must have a complete postoperative pathological specimen, and the amount of sample should be able to meet the requirements of DNA and RNA extraction and quality control; 4. Life expectancy =12 weeks; 5. Karnofsky > 60,ECOG PS 0-2; 6. Patients must have normal organ as defined below,Hemotology: absolute neutrophil count (ANC) =1.5×10^9/L; platelet count=80×10^9/L; hemoglobin concentration = 9.0 g/dL(permit to maintain hemotologic criteria by blood transfusion); Liver Function: TBil =1.5*ULN; ALT and AST =2.5*ULN; AST and ALT for the presence of liver metastases =5*ULN Renal Function: Cr =1.25*ULN, and Ccr =60ml/min; 7. Patients must comply with study protocol and procedure; 8. Patients must have the ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
Exclusion criteria: Either of the following which is not one of exclusion criteria will not be enrolled: 1. Other malignancies in the past five years;except cured basal cell carcinoma, cervical carcinoma in situ, localized prostate cancer with surgical treatment or breast ductal carcinoma in situ with surgical resection; 2. Less than 4 weeks after receiving chemotherapy, biotherapy, or other anti-cancer drugs; 3. Patients have one or more of the following: symptomatic CNS metastases or spinal cord compression; peripheral neuropathy symptoms, NCI grade>II; any unstable systemic disease (including active infection, poor control Hypertension, unstable angina, CHF, liver, kidney or metabolic diseases); can not oral delivery, requires high-energy intravenous nutrition, active peptic ulcer, chronic diarrhea; severe, uncontrolled medical and infectious diseases; severe uncontrollable digestive diseases; severe electrolyte imbalance; disseminated intravascular coagulation; Patients with gemcitabine, oxaliplatin, 5-fluorouracil and other related components allergy; 4. Cognitive ability and psychological abnormalities; 5. Can not tolerate chemotherapy or refuse chemotherapy; 6. Take other test drugs or participate in other clinical trials; 7. To be considered not suitable to attend this study (for management reasons or for other reasons).;Exclusion criteria: Either of the following which is not one of exclusion criteria will not be enrolled: 1. Other malignancies in the past five years;except cured basal cell carcinoma, cervical carcinoma in situ, localized prostate cancer with surgical treatment or breast ductal carcinoma in situ with surgical resection; 2. Less than 4 weeks after receiving chemotherapy, biotherapy, or other anti-cancer drugs; 3. Patients have one or more of the following: symptomatic CNS metastases or spinal cord compression; peripheral neuropathy symptoms, NCI grade>II; any unstable systemic disease (including active infection, poor control Hypertension, unstable angina, CHF, liver, kidney or metabolic diseases); can not oral delivery, requires high-energy intravenous nutrition, active peptic ulcer, chronic diarrhea; severe, uncontrolled medical and infectious diseases; severe uncontrollable digestive diseases; severe electrolyte imbalance; disseminated intravascular coagulation; Patients with gemcitabine, oxaliplatin, 5-fluorouracil and other related components allergy; 4. Cognitive ability and psychological abnormalities; 5. Can not tolerate chemotherapy or refuse chemotherapy; 6. Take other test drugs or participate in other clinical trials; 7. To be considered not suitable to attend this study (for management reasons or for other reasons).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;;progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Remission Rate;Disease control rate;;Overall Survival;Objective Remission Rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactHao Jihui;Hao Jihui ;
Tianjin Medical University Cancer Institute and Hospital ;Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed