Anlotinib, Toripalimab and Nab-paclitaxel in Locally Advanced/Metastatic Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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 pancreatic cancer. Totally 53 patients with locally advanced or metastatic pancreatic cancer are to be enrolled and receive anlotinib plus toripalimab and nab-paclitaxel.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

1. Males or females aged 18-75.

2. Locally advanced / metastatic pancreatic cancer confirmed by histopathology.

3. Life expectancy ≥ 3 months.

4. Treatment failure after first-line monotherapy or combination chemotherapy (at least one cycle) or after adjuvant / neoadjuvant therapy.

5. 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.

6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.

7. Adequate organ and bone marrow function.

8. 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.

9. Voluntary provision of informed consents.

Exclusion Criteria:

1. Previous treatment with anlotinib, toripalimab or nab-paclitaxel.

2. Coexistence with intestinal perforation, massive intestinal gas, acute intestinal obstruction, severe infection and so on.

3. Multiple factors affecting oral medication such as inability to swallow, chronic diarrhea and intestinal obstruction.

4. Active bleeding of primary lesions within 2 months.

5. History of congenital/acquired immunodeficiency or organ transplantation.

6. Symptomatic brain metastases or meningeal metastases.

7. 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.

8. Known to be allergic to the test drug.

9. Pregnant or breastfeeding female patients

10. Other serious hazards to the safety of patients or complications that affect the study according to the judgment of the researchers.