Clinical study of Huang Bai pellets in combination with S-1 for unresectable locally advanced or metastatic pancreatic cancer failed by gemcitabine regime
- Conditions
- Pancreatic cancer
- Registration Number
- ITMCTR2200006803
- Lead Sponsor
- Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Patients with metastatic pancreatic ductal adenocarcinoma who have a pathologically or histologically confirmed TNM staging of III (inoperable) or IV (metastatic), or who have a clinical diagnosis that can be evaluated after careful discussion by the MDT in combination with medical history, clinical manifestations, laboratory tests and imaging examinations. And the diagnosis related to the evidence of damp-heat accumulation and internal stasis of blood was met.
(2) Received treatment with a gemcitabine-containing regimen before the study was conducted and developed tumor progression or further metastasis. Gemcitabine chemotherapy must have been completed at least 2 weeks prior to study treatment and the chemotherapy toxicity produced by the gemcitabine regimen has recovered to grade 1 or baseline.
(3) Age 18 or older, gender-neutral, and physical status ECOG score of 0-2, referenced to the Eastern Cooperative Oncology Group (Zubrod-ECOG-WHO, ZPS) scale.
(4) At least one measurable lesion (spiral CT scan =10 mm, meeting RECIST 1.1 criteria).
(5) Laboratory data: blood count: total white blood cells = 3.5 × 109/L; neutrophils = 1.5 × 109/L; platelets = 80 × 109/L; hemoglobin = 90 g/L; liver and kidney function: total bilirubin = 1.5 × ULN; AST (SGOT), ALT (SGPT) = 2.5 × ULN, and < 5 ULN for patients with liver metastases. Serum creatinine = 1.5×ULN and endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula).
(6) Good compliance, informed consent must be signed before enrollment.
(7) Subjects agree not to participate in other intervention studies during the treatment period.
(1) Patients who have been judged by the investigator or the physician in charge to be unable to use tegeo chemotherapy. Patients on combination of flucytosine, phenytoin or warfarin.
(2) Combination of severe cardiovascular system complications, cerebrovascular system complications, interstitial pneumonia or pulmonary fibrosis, active hepatitis, severe hepatic or renal abnormalities, ascites or pleural effusions requiring treatment, brain metastases, other malignancies in situ.
(3) Subjects with known or suspected hypersensitivity to known components of yellow and white granular drugs, allergic individuals.
(4) Has developed intestinal obstruction that cannot be treated with oral medication and requires intravenous high-energy nutrition.
(5) Any unstable condition or condition that may jeopardize the safety of the patient and his or her compliance with the study, such as those with severe mental illnesses such as schizophrenia.
(6) Women who are pregnant, lactating, or of childbearing age may not be enrolled, and women of childbearing age may participate unless adequate contraception is available.
(7) Participation in other therapeutic clinical trials within 30 days prior to the start of the study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS;
- Secondary Outcome Measures
Name Time Method CA19-9;ORR;OS;EORTC QLQ-PAN26\CQ-11D;