advanced pancreatic cancer
Conditions
Interventions
Case series:toripalimab plus nab-paclitaxel, and gemcitabine
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18-80 years old; 2. Non resectable local advanced or metastatic pancreatic cancer patients without systemic treatment need to be confirmed by histology or cytology; for the judgment of non resectable pancreatic cancer, refer to the standard of non resectable pancreatic cancer in the guide for comprehensive diagnosis and treatment of pancreatic cancer (2018 version), and need to be judged by imaging doctors and / or surgeons; 3. The first administration time should be at least 4 weeks after major operation or trauma, and the wound must be completely healed; at least 1 week after minor operation or trauma (such as tissue core biopsy or fine needle aspiration); 4. ECoG physical strength score 0-2; 5. Estimated survival time >=3 months; 6. The functions of bone marrow were as follows: ANC >=1.5x10^9/L, Hb >=90 g/L (blood transfusion allowed), PLT >=80 x10^9/L; 7. Liver function: ALT =60 ml/ min /1.73m2; 9. The international standard prothrombin time / partial prothrombin kinase time (PT-INR / PTT) is less than 1.5 ULN. Serum sodium, potassium, calcium and magnesium levels <=level 1 standard (nci-ctcae (version 4.0)); 10. ECG showed QTc interval <=480ms; 11. There is no history of autoimmune diseases and the autoimmune diseases are being combined; 12. The subjects must have informed consent to the study before the trial, and signed the written informed consent voluntarily; 13. The subjects were able to communicate well with the researchers and complete the study according to the protocol.
Exclusion criteria
Exclusion criteria: 1. Serious, uncontrolled medical barriers or active infections that may impair the ability of subjects to receive the treatment specified in the protocol, including but not limited to HIV positive, active tuberculosis, HBV DNA copies >10^3 / ml (not more than 10^4 / ml); 2. The patient had a history of other malignancies within 5 years (except for basal cell carcinoma of skin, cervical carcinoma in situ); 3. Subjects with known or suspected new brain metastasis: subjects with signs or symptoms suggestive of brain metastasis are not allowed to participate in the study unless brain metastasis is excluded by CT or MRI. However, subjects whose brain metastases have been controlled can be selected (no radiation progression within at least 4 weeks after radiotherapy and / or no neurological symptoms or signs after surgical resection); 4. During the trial, other chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except for local symptomatic radiotherapy) or traditional Chinese medicine must be used for anti-tumor treatment; 5. The patient has used or is using chemotherapy, FAK inhibitors or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti cytotoxic T lymphocyte associated antigen 4 (CTLA-4) antibodies (including epimab or any other antibody or drug targeting T cell co stimulation or checkpoint pathway); 6. During the 7 days prior to the first administration of this study, the patient was diagnosed with immune deficiency or was receiving chronic systemic steroid treatment (more than 10 mg prednisone or equivalent per day) or any other form of immunosuppressive treatment; 7. Imaging showed that the tumor involved important blood vessels and nerves; 8. The patients were vaccinated within 30 days before the first treatment. Examples of live vaccines include, but are not limited to, measles, mumps, rubella, varicella / zoster (varicella), yellow fever, rabies, BCG and typhoid vaccines. It is allowed to use seasonal influenza vaccine for injection to kill the virus, but it is not allowed to use live attenuated vaccine such as intranasal influenza vaccine (such as FluMist); 9. Uncontrolled hypertension (systolic blood pressure > 150 mmHg and / or diastolic blood pressure > 100 mmHg after treatment); 10. LVEF < 50%; 11. Significant heart diseases, including congestive heart failure (NYHA class III-IV), previous myocardial infarction or uncontrolled angina within 6 months; 12. Arrhythmia requiring treatment, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or ventricular fibrillation, ECG abnormalities confirmed by reexamination and judged by the researchers need clinical intervention or treatment; 13. History of hemorrhagic or thromboembolic events in the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, spontaneous massive hemorrhage of tumor; 14. Surgical treatment is required within 28 days or within 28 days after the last administration; 15. There are uncontrollable third cavity effusions, such as massive pleural effusion or ascites; 16. There was gastrointestinal perforation in the past or the possibility of gastrointestinal perforation was suspected; 17. In the judgment of the researchers, the combination drugs that must be used during the trial may affect the metabolism of the product: for example, strong CYP3A4 inhibitors or inducers are mainly metabolized through CYP3A4, 2c8, 2C9, 2c19 or 2d6, and the dr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Countries
China
Contacts
Public ContactDan Cao
Department of abdominal oncology, West China Hospital, Sichuan University
Outcome results
None listed