Status:
UNKNOWN
Anlotinib, Toripalimab and Nab-paclitaxel in Locally Advanced/Metastatic Pancreatic Cancer
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Pancreatic Neoplasm
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an open-label, non-randomized, single-arm phase Ⅱ study aiming to evaluate the efficacy and safety profile of above-mentioned combination strategy in first-line therapy-failed advanced pancrea...
Detailed Description
Anlotinib Hydrochloride Capsules (12 mg orally, once daily before breakfast; CTTQ, Lianyungang, Jiangsu, China), Toripalimab (240 mg intravenously, once every 3 weeks; Shanghai Junshi Biosciences Co.,...
Eligibility Criteria
Inclusion
- Males or females aged 18-75.
- Locally advanced / metastatic pancreatic cancer confirmed by histopathology.
- Life expectancy ≥ 3 months.
- Treatment failure after first-line monotherapy or combination chemotherapy (at least one cycle) or after adjuvant / neoadjuvant therapy.
- At least one measurable tumor lesions without local treatment such as radiotherapy according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1); or tumor lesions in target area of previous radiotherapy confirmed progress.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
- Adequate organ and bone marrow function.
- Female of childbearing age must have a negative pregnancy test (serum or urine) within 7 days prior to enrolment. Males and females voluntarily use appropriate methods of contraception during study.
- Voluntary provision of informed consents.
Exclusion
- Previous treatment with anlotinib, toripalimab or nab-paclitaxel.
- Coexistence with intestinal perforation, massive intestinal gas, acute intestinal obstruction, severe infection and so on.
- Multiple factors affecting oral medication such as inability to swallow, chronic diarrhea and intestinal obstruction.
- Active bleeding of primary lesions within 2 months.
- History of congenital/acquired immunodeficiency or organ transplantation.
- Symptomatic brain metastases or meningeal metastases.
- Existence with anyone of the following conditions: severe cardiovascular diseases, liver diseases, psychiatric disorders, poorly-controlled diabetes (fasting blood glucose\>10mmol/L) or hypertension (systolic blood pressure≥150 mmHg and/ or diastolic blood pressure≥100 mmHg), active or uncontrolled severe infections, significant bleeding tendencies or under thrombolytic or anticoagulant treatment; occurrence of arterial and venous thrombotic events or clinically significant cardiovascular events within 6 months before enrollment；routine urinalysis showing urine protein ≥ ++ and confirmed 24-hour urine protein quantification \> 1.0 g.
- Known to be allergic to the test drug.
- Pregnant or breastfeeding female patients
- Other serious hazards to the safety of patients or complications that affect the study according to the judgment of the researchers.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04718701
Start Date
April 1 2021
End Date
February 1 2023
Last Update
August 16 2021
Active Locations (1)
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1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029