Last updated: September 14, 2021
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Overall Status: Active - Recruiting
Phase
4
Condition
Pancreatic Disorders
Digestive System Neoplasms
Cancer
Treatment
N/AClinical Study ID
NCT05035147
TJGI-003
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age: ≥18 years old, no gender limit;
- Inoperable locally advanced or metastatic pancreatic cancer patients (except isletcell carcinoma) diagnosed by pathology or histology;
- The patient has not undergone standard systemic treatment in the past, or more thanhalf a year after the end of postoperative treatment.For those who have undergonemajor surgery or radiotherapy, the interval must be more than 4 weeks and theirmetastases have not received any local treatment including radiotherapy, chemotherapy,surgical treatment, etc.;
- At least one measurable lesion (CT scan of tumor lesions with long diameter ≥ 10 mm,CT scan of lymph node lesions with short diameter ≥ 15 mm, and scan thickness notgreater than 6 mm);
- The main organs are functioning normally, that is, they meet the followingstandards:Routine blood examination: Hb≥90g/L (no blood transfusion within 14days);ANC ≥1.5×109/L;PLT ≥100×109/L;Biochemical examination: ALB≥29 g/L (without ALBin 14 days), TBIL <1.5 times the upper limit of normal (ULN);ALT and AST≤3ULN,accompanied by liver metastasis, then ALT and AST<5×ULN;Cr ≤1.5×ULN or creatinineclearance rate ≥60ml/min;
- The subject voluntarily joined the study and signed an informed consent form, withgood compliance and cooperation with follow-up
Exclusion
Exclusion Criteria:
- Pregnant or lactating women;
- Patients suffering from other malignant tumors in the past or at the same time, exceptfor cured skin basal cell carcinoma and cervical carcinoma in situ;
- Those who have been confirmed to be allergic to the test drug albumin-bound paclitaxeland gemcitabine or its excipients.
- The patient has clinically significant ascites;
- Those who have experienced arterial/venous thrombosis within six months, such ascerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosisand pulmonary embolism;
- Patients with active hepatitis B or C;
- Doctors think it is not suitable for inclusion.
Study Design
Total Participants: 934
Study Start date:
March 25, 2021
Estimated Completion Date:
December 31, 2026
Study Description
Connect with a study center
Rui Liu
Tianjin, Tianjin 300000
ChinaActive - Recruiting
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