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2021-04-22
2023-07
2023-07
39
NCT04814485
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
INTERVENTIONAL
Efficacy and Safety of SHR-1020 Combined With Albumin-bound Paclitaxel in the Second-line Treatment of Pancreatic Cancer
This study is being conducted to explore the efficacy and safety of SHR-1020 combined with albumin-bound paclitaxel in the second-line treatment of advanced pancreatic cancer.
This trial is a prospective, single-center, single-arm clinical research. Advanced pancreatic cancer is an aggressive disease with extremely low 5-year survival rate. For advanced pancreatic cancer patients who failed with first-line treatment, subsequent treatment options are limited. SHR-1020 combined with albumin-bound paclitaxel could through multiple mechanisms such as block tumor mitosis, inhibit tumor angiogenesis, inhibit interstitial fibrosis to achieve anti-tumor effect. The safety and efficacy of this study will be assessed through ORR, DCR,PFS, OS , and adverse effects as graded by CTCAE 5.0.
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 |
|---|---|---|
2021-03-17 | N/A | 2021-05-21 |
2021-03-22 | N/A | 2021-05-25 |
2021-03-24 | N/A | 2020-12 |
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: SHR-1020 combined with albumin-bound paclitaxel SHR-1020 combined with albumin-bound paclitaxel | DRUG: SHR-1020+albumin-bound paclitaxel
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| ORR (Objective Response Rate) | Containing the incidence of complete response (CR) and partial response (PR). Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months] |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| DCR (Disease Control Rate) | Containing the incidence of complete response (CR), partial response (PR) and stable disease (SD).Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 12 months] |
| PFS (Progression-Free-Survival) | From date of treatment start until the date of progression or the date of death due to any cause.Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | From date of treatment start until the date of progression or the date of death due to any caus, assessed up to 12 months |
| 6mPFS | 6-month- Progression-Free-Survival rate. Evaluated according to RECIST 1.1 criteria，subjects received their first tumor imaging evaluation at 8 weeks after the treatment start, followed by imaging evaluation every 2 cycles. | Up to 6 months |
| OS (overall survival) | From date of treatment start to any cause death or last follow-up. | From date of treatment start until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 12 months |
| Adverse events (per CTCAE v5.0 criteria) | To evaluate the adverse events of patients with advanced pancreatic cancer after treated with SHR-1020 plus albumin-bound paclitaxel | Up to 12months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
