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2022-01
2025-07
2025-10
58
NCT05185869
Ruijin Hospital
Ruijin Hospital
INTERVENTIONAL
SHR6390 Plus Nab-paclitaxel and Gemcitabine in Advanced/Metastatic Pancreatic Cancer
The study is being conducted to evaluate the efficacy, safety and tolerability of SHR6390 in combination with nab-paclitaxel and gemcitabine in first-line treatment of subjects with advanced/metastatic pancreatic cancer.
This is an open-label, prospective, single-center, single-arm, Simon's two-stage design phase II study for unresectable advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) subjects treated with SHR6390 plus nab-paclitaxel and gemcitabine. In this research study, the main objectives include: 1. Evaluate objective response rate in patients with pancreatic cancer receiving SHR6390 plus nab-paclitaxel and gemcitabine. 2. Assess adverse side effects associated with the combination of SHR6390 with nab-paclitaxel and gemcitabine.
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 |
|---|---|---|
2021-12-19 | N/A | 2022-01-10 |
2022-01-10 | N/A | 2022-01-11 |
2022-01-11 | N/A | 2021-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: AG+SHR6390 Subjects will receive SHR6390 plus nab-paclitaxel and gemcitabine | DRUG: SHR6390
DRUG: Nab-paclitaxel
DRUG: Gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR is defined as the proportion of patients with best objective response of confirmed complete response (CR) or partial response (PR) according to RECIST1.1. | Up to 2 years. |
| Adverse Events (AEs) | AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0. | From the first drugs administration to within 30 days for the last treatment. |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the first drugs administration to the date of death due to any cause or the last follow ship. | Up to 2 years. |
| Progression Free Survival (PFS) | PFS is defined as the time from the first drugs administration to the date of disease progression or the last follow ship. | Up to 2 years. |
| Disease Control Rate (DCR) | DCR is defined as the rate of participants who have achieved complete response, partial response and stable disease. | Up to 2 years. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Baiyong Shen, Ph.D&M.D Phone Number: 008613901943778 Email: shenby@shsmu.edu.cn |
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:
This is where you will find people and organizations involved with this study.
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
