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2024-05-22
2025-01-01
2026-09-30
37
NCT06329947
Sun Yat-sen University
Sun Yat-sen University
INTERVENTIONAL
A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD
To preliminarily evaluate whether there is a survival benefit of surufatinib combined with camrelizumab and mFOLFOX6 as the second-line treatment for advanced pancreatic cancer, and to explore the feasibility of second-line and post-line treatment for advanced pancreatic cancer
Second-line clinical study of surufatinib in combination with Caralizumab advanced pancreatic cancer
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 |
|---|---|---|
2023-12-05 | N/A | 2024-05-06 |
2024-03-18 | N/A | 2024-05-08 |
2024-03-26 | N/A | 2024-05 |
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: Experimental group Surufatinib in combination with Camrelizumab and mFOLFOX6 | DRUG: Surufatinib 250mg/d qd once daily
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1. | Time Frame: up to 24 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| disease control rate (DCR) | DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator | Time Frame: up to 24 months |
| Progression-Free Survival (PFS) | PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator | Time Frame: up to 24 months |
| overall survival (OS) | OS is the time from enrollment to death due to any cause. | Time Frame: up to 24 months |
| quality of life (QoL) | Assessing the quality of life of cancer patients by QLQ-C30 | Time Frame: up to 24 months |
| adverse events (AE) | overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use. | Time Frame: up to 24 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Rui Hua Xu, MD Phone Number: 13922206676 Email: xurh@sysucc.org.cn |
Study Contact Backup Name: Hui Yan Luo, DR Phone Number: 13719459226 Email: luohy@sysucc.org.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
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.
