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

NCT04718701 | Unknown Phase 2

• 1 other identifier: 2020-SR-496
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Conditions

Pancreatic Neoplasm; Metastatic Pancreatic Cancer; Locally Advanced Pancreatic Adenocarcinoma

Keywords

Locally advanced pancreatic cancer; Metastatic pancreatic cancer; Anlotinib; Toripalimab; Nab-paclitaxel; Chemotherapy; PD-1 blockade; multi-targeted TKI

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  From allocation to first disease progression confirmed by imaging modalities or all cause death, whichever occurs first.

  Up to 24 months.

Secondary Outcomes (5)

• Overall survival (OS)

  Up to 24 months.

• Object response rate (ORR)

  Up to 24 moths.

• Disease control rate (DCR)

  Up to 24 months.

• Quality of life (QoL)

  up to 24 months.

• The incidence and severity of adverse events (AEs) and severe adverse events (SAEs)

  Up to 24 months.

Study Arms (1)

Experimental Group

EXPERIMENTAL

Patients who failed first-line therapy with locally advanced or metastatic pancreatic cancer will be assigned to receive anlotinib plus toripalimab and nab-paclitaxel as second-line or maintenance treatment.

Drug: Anlotinib+Toripalimab+Nab-paclitaxel

Interventions

Anlotinib+Toripalimab+Nab-paclitaxel DRUG

Using combination treatment of anlotinib (12 mg, po. qd.) plus toripalimab (240 mg, ivgtt. q3w.) and nab-paclitaxel (260 mg/m2, ivgtt, q3w) with every 3 weeks as a cycle.

Also known as: combination therapy

Experimental Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ling Xiang Liu, Physician

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Xiang Liu, Physician

CONTACT

13851892074; llxlau@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 22, 2021
• Study Start: April 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication.
• Access Criteria: IPD will be shared to other related clinical trials or systematic review after reviewing requests by chief investigator and examiners.

Locations

CN (1)