Pancreatic cancer
Conditions
Interventions
Experimental group:Pharmacological treatment with surufatinib
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, both males and females are eligible; 2. Patients with pancreatic cancer confirmed by pathological histology or cytology; 3. ECOG score of 0-2 (see Appendix 1); 4. Expected survival >=12 weeks; 5. At least one measurable lesion (RECIST 1.1 criteria, see Appendix 2); 6. Fully informed about the study, voluntarily participates, and signs the informed consent form. 7. Male or female patients of reproductive potential must use effective contraception during the study period and for at least 6 months after the last dose of the study drug, such as double-barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered capable of childbearing unless they have naturally reached menopause, undergone artificial menopause, or sterilization procedures (such as hysterectomy, bilateral salpingo-oophorectomy, or radioactive ovarian irradiation); 8. The function of major organs and bone marrow is basically normal; 9. Confirmed by imaging (CT or MRI) or surgical exploration as locally advanced unresectable pancreatic cancer, referring to NCCN guidelines, as defined as follows: (1) Inability to safely reconstruct the portal vein-superior mesenteric vein due to tumor invasion, venous occlusion, or involvement of a large superior mesenteric vein-jejunal branch. (2) If pancreatic head/uncinate tumor: the tumor > 180° in contact with the superior mesenteric artery or celiac trunk artery. If pancreatic tail tumor: the tumor contacts the superior mesenteric artery or the celiac trunk artery > 180°, and the tumor touches the celiac trunk artery and infiltrates the abdominal aorta; 10. Patients who refuse chemotherapy or do not tolerate chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with other malignant tumors within the past 5 years, except for effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer and breast cancer that have been effectively excised; 2. Currently receiving other experimental drugs or approved or under-research antitumor treatments; 3. Patients with contraindications to Sorafenib (such as active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension by medication, grade III-IV cardiac insufficiency, within 30 days post major surgery, severe liver and kidney dysfunction, etc.); 4. Patients currently have any disease or condition affecting drug absorption, or cannot take Sorafenib orally; 5. Proven allergy to the test drug and/or any component of its excipients; 6. Pregnancy (positive pregnancy test before medication) or breastfeeding women; 7. Patients requiring drainage due to significant pleural effusion or ascites; 8. Any other diseases with clinically significant metabolic abnormalities, physical examination anomalies, or laboratory test abnormalities, which according to the investigator's judgment, may suggest the patient has a condition unsuitable for using the study medication (e.g., epilepsy requiring treatment), or might affect the interpretation of the study results, or put the patient at high risk; 9. Taken medications containing Hypericum perforatum within 3 weeks prior to the first administration of the study drug, or taken strong inducers or inhibitors of CYP3A4 within the last 2 weeks; 10. The investigator determines that liver metastases account for 50% or more of the total liver volume; 11. Biliary obstruction requiring clinical intervention is judged by the investigator not to have resolved or requires anti-infection treatment 14 days prior to the first study drug treatment; 12. Previously underwent liver transplantation; 13. Any other diseases with clinically significant metabolic abnormalities, physical examination anomalies, or laboratory test abnormalities, which according to the investigator's judgment, may suggest the patient has a condition unsuitable for using the study medication (e.g., epilepsy requiring treatment), or might affect the interpretation of the study results, or put the patient at high risk; 14. According to the investigator's judgment, patients have other factors that may affect the study results or lead to forced mid-term termination of this study, such as alcohol abuse, drug abuse, other serious diseases (including mental illnesses) requiring combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that could affect patient safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall survival;Disease control rate;Resection rate of R0; | — |
Countries
China
Contacts
Public ContactChang Hong
Shandong Provincial Hospital
Outcome results
None listed