An Open-label, Phase I/II Study Of PLENA Regimen In Patients With Unresectable Pancreatic Cancer Or BTC

Study Overview

An Open-label, Phase I/II Study of PLENA Regimen in Patients With Unresectable Pancreatic Cancer or BTC

Immunotherapy of cancer based on PD-1/PD-L1 blockade has prompted a revolution in cancer clinical management, albeit as yet immunotherapy-based treatment approaches in pancreatic cancer and biliary tract cancer (BTC) remain to have proven value, highlights the urgency for designing novel therapeutic strategies to combat these deadly diseases. The immunomodulatory effect of lenvatinib (Lenvatinib is an oral multi-kinase inhibitor) on tumor microenvironments may contribute to antitumor activity of immune checkpoint blockade. This one-arm, phase I/II study is designed to assess the safety and efficacy of the combined regimen of Durvalumab (anti-PD-L1 antibody), Lenvatinib and Paclitaxel albumin (nab-paclitaxel).

N/A

Pancreatic Cancer
Biliary Tract Cancer

DRUG: Durvalumab
DRUG: Lenvatinib
DRUG: Nab paclitaxel

CHN-PLAGH-BT-070

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-04-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2022-04-07
First Submitted that Met QC Criteria 2022-04-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2022-04-14
First Posted (ACTUAL) 2022-04-14	Results First Posted N/A	Last Verified 2022-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: PLENA regimen Subject received PLENA regimen every 3 weeks until achieving a second assessable complete response or up to a maximum of 8 cycles. Treatment continued until progressive disease or intolerable toxicity, or withdrawal of consent.	DRUG: Durvalumab Administered intravenously, 1000 mg on day 1 in a 3-week cycle DRUG: Lenvatinib Administered orally, 8mg/d once daily in a 3-week cycle DRUG: Nab paclitaxel Administered intravenously, 180-220 mg/m2 on day1 in a 3-week cycle

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: PLENA regimen

Subject received PLENA regimen every 3 weeks until achieving a second assessable complete response or up to a maximum of 8 cycles. Treatment continued until progressive disease or intolerable toxicity, or withdrawal of consent.

DRUG: Durvalumab

Administered intravenously, 1000 mg on day 1 in a 3-week cycle

DRUG: Lenvatinib

Administered orally, 8mg/d once daily in a 3-week cycle

DRUG: Nab paclitaxel

Administered intravenously, 180-220 mg/m2 on day1 in a 3-week cycle

Primary Outcome Measures	Measure Description	Time Frame
Number of Subjects with treatment-related adverse events (AEs)	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. AEs were considered to be treatment-related if they had started or worsened within the interval from first study drug administration until the follow-up visit.	6 months
Object response rate (ORR)	ORR is defined as the proportion of subjects who achieved a partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	12 months

Secondary Outcome Measures	Measure Description	Time Frame
Disease control rate (DCR)	DCR is defined as the proportion of subjects who achieved a stable disease (SD), partial response (PR) or complete response (CR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.	12 months
Progression-free survival (PFS)	PFS time was measured from study entry to the first documentation of disease progression or death. Disease progression was determined per the RECIST V1.1.	12 months
Overall survival (OS)	OS time was measured from the study entry to the date of death.	24 months
Number of participants with laboratory test abnormalities	The laboratory tests of serum cytokines and chemokines will be performed on day 1 of each cycle, and the abnormality will be determined by the investigator.	12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Weidong Han

Phone Number: +861066937463

Email: hanwdrsw@sina.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Weidong Han, Dr, Chinese PLA General Hospital

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

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Clinical Trial Record