2024-08-01
2025-06-01
2027-06-01
30
NCT06435260
Hebei Medical University Fourth Hospital
Hebei Medical University Fourth Hospital
INTERVENTIONAL
Hypofractionated Radiotherapy +Chemotherapy+ Camrelizumab as Neoadjuvant Therapy for Pancreatic Cancer
The purpose of this study is to assess surgical conversion rate and the immediate and long-term outcomes to patients who receive hypofractionated radiotherapy and AG combined with camrelizumab immunotherapy of Borderline Resectable/locally advanced pancreatic cancer.
N/A
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 |
|---|---|---|
2024-05-24 | N/A | 2025-03-10 |
2024-05-29 | N/A | 2025-03-25 |
2024-05-30 | N/A | 2025-03 |
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: Hypofractionated radiotherapy+Camrelizumab+chemotherapy The patients with Borderline Resectable/locally advanced pancreatic cancer were treated with hypofractionated radiotherapy using the CyberKnife radiotherapy machine, which was as follows: PGTV=30Gy/5F(PTV≥25Gy/5F), 1 day, a total of 5 days; Chemotherapy c | DRUG: Camrelizumab+chemotherapy
RADIATION: hypofractionated radiotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| a.R0-resection rate | The tumor was completely removed during surgery, and the cutting margins were also negative when viewed microscopically | One week after surgery |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Surgical conversion rate | Tumors that were otherwise unresectable were transformed into surgically resectable tumors. | 2 to 4 weeks after neoadjuvant therapy |
| Tumor regression rate | Degree of tumor response to neoadjuvant therapy | One week after surgery |
| Objective response rate (ORR) | It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1). | through study completion，an average of 3 year |
| Disease control rate (DCR) | It refers to the proportion of patients who achieve a prespecified reduction in tumor volume (CR/PR/SD) and maintain the minimum time requirements according to accepted response evaluation criteria (e.g., RECIST in solid tumors, version 1.1). | through study completion，an average of 3 year |
| 3-year Overall survival (OS) | The time between the start of randomization and death from any cause | Three years from enrollment |
| 3-year Event Free Survival (EFS) | The time from randomization until disease progression, treatment discontinuation for any cause, or death. | Three years from enrollment |
| Adverse events | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of participants with adverse events will be recorded at each treatment visit. | From enrollment to the end of treatment at 8 weeks |
| Quality of life scores | Evaluate the quality of life according to The World Health Organization quality of life (WHOQOL) -BREF. The minimum value is 1, the maximum value is 5. And higher scores mean a better outcome. The number of participants with quality of life will be recorded at each treatment visit. | 1 years after therapy |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Li Peng Phone Number: 13933868818 Email: pengli72@sina.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
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