Status:
UNKNOWN
Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.
Detailed Description
This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer pa...
Eligibility Criteria
Inclusion
- Patients who were diagnosed as metastatic or locally advanced unresectable pancreatic ductal adenocarcinoma by histopathology or cytology, at least one measurable lesion conforming to RECIST 1.1 criteria.
- Disease progresses or intolerance for first-line standard treatment, including patients who relapsed or metastasized within 6 months of neoadjuvant or adjuvant therapy
- ECOG score 0-2
- Adequate organ and bone marrow function
- The expected survival time is ≥ 12 weeks
- Had normal swallowing function, without dysfunction of gastrointestinal absorption
- Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures
Exclusion
- The patient has previously received anti-angiogenic drugs or albumin-bound paclitaxel;
- The first study drug treatment was less than 2 weeks or 5 half-lives (in terms of longer) from the last chemotherapy or 5 half-lives from the last targeted therapy
- Known to be allergic to the active ingredients or excipients in this study.
- Had other active malignant tumors within 5 years before entering the study.
- Subject with cerebral metastasis
- Have a clear history of serious and uncontrolled other disease or mental disorders;
- Other chemotherapy, targeted therapy, hormonotherapy, immunotherapy, radiotherapy or traditional Chinese medicine should be used for anti-tumor therapy
- Other situations that the researcher considers inappropriate to participate in the research.
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04814485
Start Date
April 22 2021
End Date
July 1 2023
Last Update
May 25 2021
Active Locations (1)
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1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300000