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2024-05-08
2027-08-31
2027-08-31
482
NCT06361888
Hutchmed
Hutchmed
INTERVENTIONAL
A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer
To evaluate the efficacy of Surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer
This is a multicenter, randomized, open-label, active-controlled, phase II/III trial to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic 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 |
|---|---|---|
2024-03-26 | N/A | 2024-05-12 |
2024-04-11 | N/A | 2024-05-14 |
2024-04-12 | 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:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine | DRUG: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
|
| ACTIVE_COMPARATOR: Nab-paclitaxel Plus Gemcitabine | DRUG: Nab-paclitaxel Plus Gemcitabine
|
| OTHER: Surufatinib with Nab-paclitaxel, and Gemcitabine | DRUG: Surufatinib with Nab-paclitaxel, and Gemcitabine
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Duration from the date of initial treatment to the date of death due to any cause | From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) (RECIST1.1) | A duration from the date of initial treatment to disease progression or death of any cause. | From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months) |
| Objective response rate (ORR)(RECIST1.1) | The incidence of confirmed complete response or partial response | From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months) |
| Duration of response (DoR)(RECIST1.1) | Duration from the first time reported partial response or complete response to the first time of disease progression or death. | From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months) |
| Disease control rate (DCR)(RECIST1.1) | Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit. | From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 20 months) |
| Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) | The changes in health-related quality of life (HRQoL) score from baseline and the time to deterioration of symptoms (TTD) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) | From the within 7 days prior to the initiation of treatment to 30 days after the last administration |
| Cancer Quality of Life Questionnaire - PAN26(EORTC QLQ-PAN26) | The changes in health-related quality of life (HRQoL) score from baseline and thehe time to deterioration of symptoms (TTD) as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - PAN26 (EORTC QLQ-PAN26) | From the within 7 days prior to the initiation of treatment to 30 days after the last administration |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Panfeng Tan Phone Number: +86 21 20671828 Email: panfengt@hutch-med.com |
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
