Pancreatic NeoplasmsNCT06231160
Clinical Comparative Study of Systematic Therapy Combined With MWA and Systematic Therapy for Pancreatic Cancer
An observational study of Pancreatic Neoplasms and Ablation, run by Chinese PLA General Hospital.
Trial summary
Pancreatic carcinoma (PC) is the deadliest malignant tumors worldwide. Surgical resection is one of the most effective methods for the treatment of PC, but the resectable rate is less than 20% among the patients with PCs, and the recurrent and metastatic rate is more than 80% in two years after resection. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Neoplasms, Ablation
- What is being tested?
- Systematic Therapy Combined With Microwave Ablation
- Type of treatment
- Surgery or procedure
- How many people
- 185 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pancreatic cancer
Who may be able to join
- Inoperable pancreatic cancer
- Age from 18 to 80
- PS score from 0 to 3
- Clear pathological diagnosis
Who cannot join
- Severe coagulation dysfunction
- Individuals with severe heart, lung, liver, and kidney dysfunction
- Individuals with acute or active infectious lesions in any part of the body
- Researchers believe that there are any other factors that are not suitable for inclusion or that affect the participation of participants in the study
- Psychological health issues that hinder this experiment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Comparative Study of Systematic Therapy Combined With Microwave Ablation and Systematic Therapy for Pancreatic Cancer
Pancreatic carcinoma (PC) is the deadliest malignant tumors worldwide. Surgical resection is one of the most effective methods for the treatment of PC, but the resectable rate is less than 20% among the patients with PCs, and the recurrent and metastatic rate is more than 80% in two years after resection. Ablation has been confirmed one of the most effective methods for solid tumors by recent twenty years and proven to be a radical treatment similar to the surgical resection for the clinical applications of hepatic and renal tumors at early clinical staging in the internationally guidelines. The purpose is to explore the efficacy and safety of microwave ablation in the treatment of pancreatic cancer in combination with systematic therapy.
Read the detailed description
Pancreatic carcinoma (PC) is the deadliest malignant tumors worldwide. Surgical resection is one of the most effective methods for the treatment of PC, but the resectable rate is less than 20% among the patients with PCs, and the recurrent and metastatic rate is more than 80% in two years after resection. Furthermore, it is difficult to achieve tumoral complete responses by traditional therapies including chemotherapy, radiotherapy and transarterial embolization. Ablation has been confirmed one of the most effective methods for solid tumors by recent twenty years and proven to be a radical treatment similar to the surgical resection for the clinical applications of hepatic and renal tumors at early clinical staging in the internationally guidelines. However, the published clinical practices on the thermal ablation of PCs with large-scale cases are rare. One of the most important reasons for this originates from the extreme complexity and difficult regulation of the temperature distribution in tumors during thermal ablation because of the own characteristics of PCs, including highly invasive growth without tumoral capsules, high proportion of the interstitial fiber tissue, and the unusual blood perfusion because of extremely chaotic microvascular structures. The purpose is to explore the efficacy and safety of microwave ablation in the treatment of pancreatic cancer in combination with systematic therapy.
- Conditions
- Pancreatic Neoplasms, Ablation
- Being tested
- Systematic Therapy Combined With Microwave Ablation
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic Therapy Combined With Microwave AblationProcedure or surgery
Also called Systematic Therapy
Patients with unresectable pancreatic cancer were included for laboratory examination, and quality of life and pain scores were recorded. The experimental group underwent microwave ablation first, followed by chemotherapy according to the guidelines; The control group received the same chemotherapy. Record the use of chemotherapy drugs and the occurrence of adverse events. Follow up will be conducted at 30 days, 90 days, and 180 days after chemotherapy to evaluate pancreatic function and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Systematic Therapy Combined With Microwave Ablation | Perform microwave ablation for patients with pancreatic cancer, and then conduct chemotherapy according to the guidelines two to three weeks later Receives: Procedure: Systematic Therapy Combined With Microwave Ablation | |
| Systematic Therapy | Using the same chemotherapy method as the experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Time from receiving treatment to death
Measured: 30, 90, and 180 days after the end of the last chemotherapy
Secondary outcomes (1)
Pain relief rate
Pain relief before and after treatment
Measured: 30, 90, and 180 days after the end of the last chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Liang, Chinese PLA General Hospital
- Investigators
- Ping Liang, Study chair, The Fifth Medical Center of the General Hospital of the PLA of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231160
- Sponsor's protocol ID
- 82171941
- Status last verified
- Jan 2024
- First submitted
- 24 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
PubMed 36633525Kluger MD, Epelboym I, Schrope BA, Mahendraraj K, Hecht EM, Susman J, Weintraub JL, Chabot JA. Single-Institution Experience with Irreversible Electroporation for T4 Pancreatic Cancer: First 50 Patients. Ann Surg Oncol. 2016 May;23(5):1736-43. doi: 10.1245/s10434-015-5034-x. Epub 2015 Dec 29.
PubMed 26714959Wang Z, Liu M, Zhang DZ, Wu SS, Hong ZX, He GB, Yang H, Xiang BD, Li X, Jiang TA, Li K, Tang Z, Huang F, Lu M, Chen JA, Lin YC, Lu X, Wu YQ, Zhang XW, Zhang YF, Cheng C, Ye HL, Wang LT, Zhong HG, Zhong JH, Wang L, Chen M, Liang FF, Chen Y, Xu YS, Yu XL, Cheng ZG, Liu FY, Han ZY, Tang WZ, Yu J, Liang P. Microwave ablation versus laparoscopic resection as first-line therapy for solitary 3-5-cm HCC. Hepatology. 2022 Jul;76(1):66-77. doi: 10.1002/hep.32323. Epub 2022 Jan 28.
PubMed 35007334Fegrachi S, Walma MS, de Vries JJJ, van Santvoort HC, Besselink MG, von Asmuth EG, van Leeuwen MS, Borel Rinkes IH, Bruijnen RC, de Hingh IH, Klaase JM, Molenaar IQ, van Hillegersberg R. Safety of radiofrequency ablation in patients with locally advanced, unresectable pancreatic cancer: A phase II study. Eur J Surg Oncol. 2019 Nov;45(11):2166-2172. doi: 10.1016/j.ejso.2019.06.008. Epub 2019 Jun 12.
PubMed 31227340Martin RC 2nd, Kwon D, Chalikonda S, Sellers M, Kotz E, Scoggins C, McMasters KM, Watkins K. Treatment of 200 locally advanced (stage III) pancreatic adenocarcinoma patients with irreversible electroporation: safety and efficacy. Ann Surg. 2015 Sep;262(3):486-94; discussion 492-4. doi: 10.1097/SLA.0000000000001441.
PubMed 26258317Vogl TJ, Panahi B, Albrecht MH, Naguib NNN, Nour-Eldin NA, Gruber-Rouh T, Thompson ZM, Basten LM. Microwave ablation of pancreatic tumors. Minim Invasive Ther Allied Technol. 2018 Feb;27(1):33-40. doi: 10.1080/13645706.2017.1420664. Epub 2017 Dec 26.
PubMed 29278340
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparative Study of Systematic Therapy Combined With Microwave Ablation and Systematic Therapy for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06231160
- Acronym / sponsor ID
- 82171941
- Conditions
- Pancreatic Neoplasms, Ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pancreatic carcinoma (PC) is the deadliest malignant tumors worldwide. Surgical resection is one of the most effective methods for the treatment of PC, but the resectable rate is less than 20% among the patients with PCs, and the recurrent and metastatic rate is more than 80% in two years after resection. Ablation has been confirmed one of the most effective methods for solid tumors by recent twenty years and proven to be a radical treatment similar to the surgical resection for the clinical applications of hepatic and renal tumors at early clinical staging in the internationally guidelines. The purpose is to explore the efficacy and safety of microwave ablation in the treatment of pancreatic cancer in combination with systematic therapy.
Detailed description
Pancreatic carcinoma (PC) is the deadliest malignant tumors worldwide. Surgical resection is one of the most effective methods for the treatment of PC, but the resectable rate is less than 20% among the patients with PCs, and the recurrent and metastatic rate is more than 80% in two years after resection. Furthermore, it is difficult to achieve tumoral complete responses by traditional therapies including chemotherapy, radiotherapy and transarterial embolization. Ablation has been confirmed one of the most effective methods for solid tumors by recent twenty years and proven to be a radical treatment similar to the surgical resection for the clinical applications of hepatic and renal tumors at early clinical staging in the internationally guidelines. However, the published clinical practices on the thermal ablation of PCs with large-scale cases are rare. One of the most important reasons for this originates from the extreme complexity and difficult regulation of the temperature distribution in tumors during thermal ablation because of the own characteristics of PCs, including highly invasive growth without tumoral capsules, high proportion of the interstitial fiber tissue, and the unusual blood perfusion because of extremely chaotic microvascular structures. The purpose is to explore the efficacy and safety of microwave ablation in the treatment of pancreatic cancer in combination with systematic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systematic Therapy Combined With Microwave Ablation | – | Procedure: Systematic Therapy Combined With Microwave AblationPerform microwave ablation for patients with pancreatic cancer, and then conduct chemotherapy according to the guidelines two to three weeks later |
| Systematic Therapy | – | –Using the same chemotherapy method as the experimental group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic cancer
Key inclusion criteria (4 listed)
- Inoperable pancreatic cancer
- Age from 18 to 80
- PS score from 0 to 3
- Clear pathological diagnosis
Key exclusion criteria (5 listed)
- Severe coagulation dysfunction
- Individuals with severe heart, lung, liver, and kidney dysfunction
- Individuals with acute or active infectious lesions in any part of the body
- Researchers believe that there are any other factors that are not suitable for inclusion or that affect the participation of participants in the study
- Psychological health issues that hinder this experiment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic Therapy Combined With Microwave AblationAlso: Systematic TherapyPatients with unresectable pancreatic cancer were included for laboratory examination, and quality of life and pain scores were recorded. The experimental group underwent microwave ablation first, followed by chemotherapy according to the guidelines; The control group received the same chemotherapy. Record the use of chemotherapy drugs and the occurrence of adverse events. Follow up will be conducted at 30 days, 90 days, and 180 days after chemotherapy to evaluate pancreatic function and quality of life. | Procedure or surgery | Systematic Therapy Combined With Microwave Ablation |
Primary outcome
overall survival
Time frame: 30, 90, and 180 days after the end of the last chemotherapy
Time from receiving treatment to death
1 secondary outcome
Pain relief rate
Time frame: 30, 90, and 180 days after the end of the last chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 36633525Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.
- Background: PubMed 26714959Kluger MD, Epelboym I, Schrope BA, Mahendraraj K, Hecht EM, Susman J, Weintraub JL, Chabot JA. Single-Institution Experience with Irreversible Electroporation for T4 Pancreatic Cancer: First 50 Patients. Ann Surg Oncol. 2016 May;23(5):1736-43. doi: 10.1245/s10434-015-5034-x. Epub 2015 Dec 29.
- Background: PubMed 35007334Wang Z, Liu M, Zhang DZ, Wu SS, Hong ZX, He GB, Yang H, Xiang BD, Li X, Jiang TA, Li K, Tang Z, Huang F, Lu M, Chen JA, Lin YC, Lu X, Wu YQ, Zhang XW, Zhang YF, Cheng C, Ye HL, Wang LT, Zhong HG, Zhong JH, Wang L, Chen M, Liang FF, Chen Y, Xu YS, Yu XL, Cheng ZG, Liu FY, Han ZY, Tang WZ, Yu J, Liang P. Microwave ablation versus laparoscopic resection as first-line therapy for solitary 3-5-cm HCC. Hepatology. 2022 Jul;76(1):66-77. doi: 10.1002/hep.32323. Epub 2022 Jan 28.
- Background: PubMed 31227340Fegrachi S, Walma MS, de Vries JJJ, van Santvoort HC, Besselink MG, von Asmuth EG, van Leeuwen MS, Borel Rinkes IH, Bruijnen RC, de Hingh IH, Klaase JM, Molenaar IQ, van Hillegersberg R. Safety of radiofrequency ablation in patients with locally advanced, unresectable pancreatic cancer: A phase II study. Eur J Surg Oncol. 2019 Nov;45(11):2166-2172. doi: 10.1016/j.ejso.2019.06.008. Epub 2019 Jun 12.
- Background: PubMed 26258317Martin RC 2nd, Kwon D, Chalikonda S, Sellers M, Kotz E, Scoggins C, McMasters KM, Watkins K. Treatment of 200 locally advanced (stage III) pancreatic adenocarcinoma patients with irreversible electroporation: safety and efficacy. Ann Surg. 2015 Sep;262(3):486-94; discussion 492-4. doi: 10.1097/SLA.0000000000001441.
- Background: PubMed 29278340Vogl TJ, Panahi B, Albrecht MH, Naguib NNN, Nour-Eldin NA, Gruber-Rouh T, Thompson ZM, Basten LM. Microwave ablation of pancreatic tumors. Minim Invasive Ther Allied Technol. 2018 Feb;27(1):33-40. doi: 10.1080/13645706.2017.1420664. Epub 2017 Dec 26.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreatic Neoplasms
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ping Liang study chair
The Fifth Medical Center of the General Hospital of the PLA of China
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms and Ablation, run by Chinese PLA General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ping Liang (66939530, liangping301@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 30, 90, and 180 days after the end of the last chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06231160, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.