Pancreatic cancer
Conditions
Interventions
Huaier Group:Huaier granule combined with capecitabine
Control Group:Capecitabine monotherapy
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age =18 years old, gender is not limited; (2) There was a clear evaluable lesion (RECIST 1.1), which was confirmed as pancreatic adenocarcinoma by histopathology. Radical surgical resection was not feasible in clinical evaluation (jaundice and digestive tract obstruction caused by tumor compression could be normally included by stents or bilioenterostomy); (3) Patients voluntarily give up conversion therapy, local radiation therapy, targeted immunization and other programs; (4) Patients voluntarily chose chemotherapy, and the regimen was capecitabine alone; (5) Score 1-3 by Zubrod-ECOG-WHO (ZPS, 5-point method); (6) Voluntarily participate in and cooperate with the research work, including but not limited to cooperating with treatment and follow-up, cooperating with researchers for data collection, not taking other treatments voluntarily, and signing informed consent.
Exclusion criteria
Exclusion criteria: (1) Known to be allergic to the components of Huaier granules or avoid or use Huaier granules with caution (Huaier group); (2) Patients with difficulty in taking oral drugs due to dysphagia, complete or incomplete digestive tract obstruction (patients with normal diet after gastrointestinal tract diversion due to gastrointestinal tract obstruction caused by tumor were excluded from this list, and could be included in the normal study), active gastrointestinal bleeding, perforation, etc.; (3) After active yellow reduction (including but not limited to external drainage of biliary/gallbladder puncture, external nasobiliary drainage, internal biliary stent drainage, internal bilioenterostomy drainage, etc.), the total bilirubin was still 1.5 times higher than the upper limit of normal; (4) History of other malignant tumors; (5) Patients with myocardial infarction, cerebral infarction and other thromboembolic diseases requiring surgical treatment; (6) complicated with severe infection; (7) Child-Pugh grade C liver function and renal function grade 2-5 (glomerular filtration rate < 90ml/min); (8) Pregnant or lactating women or planning to become pregnant; (9) have received other Chinese patent medicines with anti-tumor efficacy within the past 4 weeks (including but not limited to compound cantharidin capsules, Sinofin capsules, Kangai injection, the specific instructions shall prevail), or chemotherapy, or physical therapy; (10) Serious mental illness or other reasons cause the researcher to think that it is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| RECIST assessment (ORR);1 year progression-free survival;Conversion rate;Quality of Life Rating (SF-36 Scale);Incidence and severity of adverse events and serious adverse events;Incidence and severity of adverse events and serious adverse events; | — |
Countries
China
Contacts
Public ContactZheng Wang
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed