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A multicenter randomized controlled clinical study of Fuzheng Xiaoji pill in the treatment of metastatic pancreatic cancer

Phase 1
Recruiting
Conditions
Pancreatic cancer
Registration Number
ITMCTR2000003298
Lead Sponsor
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Patients over 18 years old;
2. There is definite histopathological or cytological pathological diagnosis. The TNM stage of AJCC pancreatic cancer is stage IV, or combined with the history, clinical manifestations, laboratory examination and imaging examination, the preliminary clinical diagnosis should be made carefully after discussion by MDT, and the evaluable metastatic pancreatic duct adenocarcinoma that has not received chemotherapy in the past;
3. Patients with ECoG score of 0-2, referring to Zps standard of Eastern Cooperative Oncology Group (Zps);
4. Adequate bone marrow function (granulocyte count >= 1500 / m3, platelet count >= 100000 / m3), liver function (bilirubin <=1.5 times the upper limit of normal range) and renal function.

Exclusion Criteria

1. Patients over 76 years old;
2. Patients with pancreatic endocrine tumor, acinar epithelial tumor, mature teratoma, mesenchymal tumor, malignant lymphoma and secondary tumor;
3. The assessable lesions had received radiotherapy, brain metastasis, other malignant tumors, active infection, chronic diarrhea, history of heart with significant clinical impact, pregnancy or lactation;
4. Patients known to be allergic to the study drug;
5. Patients undergoing other drug trials.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Quality of life;Survival time;
Secondary Outcome Measures
NameTimeMethod
CA19-9;ECOG;Sum of the longest tumor diameter;
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