Pancreatic Cancer Metastatic to LiverPhase 2NCT04677192
Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis
A Phase 2 study testing Microwave Ablation combination with chemotherapy in people with Pancreatic Cancer Metastatic to Liver and Oligometastasis, run by Fudan University at 1 site in China.
Trial summary
This study is a prospective, single center, single arm, phase II clinical study in patients with liver metastasis after radical resection of pancreatic cancer. The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer Metastatic to Liver, Oligometastasis
- What is being tested?
- Microwave Ablation combination with chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jan 2021to Dec 2022
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 to 75years old, male or female;
- ECOG PS: 0-2 points;
- Patients with pancreatic ductal adenocarcinoma diagnosed by histology or cytology;
- Expected survival time> 3 months;
- The functions of important organs meet the following requirements;
- The maximum diameter of single lesion ≤ 5cm or the number of multiple lesions ≤ 5 and the maximum diameter ≤ 3cm;
Show all 14Show fewer
- Measurable lesions that meet RECIST criteria.
- Platelet ≥75×109/L, hemoglobin ≥85g/L，white blood cell ≥ 3.0 × 109 / L;
- Total bilirubin ≤ 1.5 times upper limit of normal value (ULN) ; ALT and AST ≤ 5 times ULN ;
- Albumin ≥ 28g / L;
- Creatinine ≤ 1.5 times ULN, or creatinine clearance rate ≥ 50ml / min;
- Women of childbearing age must undergo a negative pregnancy test (βHCG) before starting treatment. Women and men of childbearing age (sexual relationships with women of childbearing age) must agree to use them effectively during treatment and 3 months after the last dose of treatment Contraceptive measures;
- Signature of patient information and informed consent.
- Patients who did not participate in other clinical trials within 4 weeks before screening; those who failed in other trials but met the requirements of this trial could be enrolled.
Who cannot join
- Patients with distant metastasis include but not limited to lung metastasis, bone metastasis and brain metastasis;
- Other serious diseases or conditions, including congestive heart failure (NYHA grade III or IV), unstable angina, myocardial infarction and cerebral infarction in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, mental disorders, drug abuse, etc;
- Women who are pregnant or nursing, or have fertility but refuse to take contraceptive measures;
- During the enrollment period, a serious active infection requiring antibiotic intravenous treatment occurred;
- In addition to cervical carcinoma in situ, basal cell carcinoma and superficial bladder tumor (TA, tis \& T1). Any cancer cured for more than 3 years before enrollment was allowed to be enrolled;
- Patients who cannot follow the trial protocol or cannot cooperate with follow-up;
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
About this study
Official title: Effectiveness and Safety Evaluation of Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis: A Prospective, Single-center, Single-arm, Phase II Clinical Study
This study is a prospective, single center, single arm, phase II clinical study in patients with liver metastasis after radical resection of pancreatic cancer. The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.
Read the detailed description
Microwave ablation, as one of the important treatment methods of liver metastases, has the advantages of radical effect, small trauma and rapid recovery.Microwave ablation combined with chemotherapy aims to improve the quality of life and prolong the survival time.The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.
- Being tested
- Microwave Ablation combination with chemotherapy
- Keywords
- Pancreatic Cancer Metastatic to Liver, Oligometastasis, Microwave Ablation, overall survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave Ablation combination with chemotherapyCombination product
Microwave Ablation combination with chemotherapy. Maximum tumor diameter ≤ 3cm, single microwave needle, maximum tumor diameter> 3cm, double ablation needle, the ablation range completely covers the lesion ≥ 0.5cm in order to obtain a satisfactory ablation margin. After the operation, contrast ultrasound is performed again to confirm the ablation edge. Enhanced MRI or CT to evaluate the ablation effect 4 weeks after surgery. Selection of chemotherapy regimen refers to the 2020 NCCN Guidelines for Pancreatic Cancer. First-line chemotherapy regimen: gemcitabine combined with albumin-bound paclitaxel or FOLFIRINOX; second-line chemotherapy regimen: If first-line chemotherapy based on gemcitabine, 5-FU-based regimen for second-line, If 5-FU-based regimen for first-line, gemcitabine for second-line.
| Study group | Role | What they receive |
|---|---|---|
| Microwave Ablation Combined with Chemotherapy | Experimental | All patients will receive microwave ablation of oligohepatic metastasis and chemotherapy according to NCCN guidelines,and the efficacy was evaluated every 8 weeks until the disease progressed or the patient could not tolerate it. Receives: Combination Product: Microwave Ablation combination with chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS
Overall survival
Measured: 24months
Secondary outcomes (4)
6-month PFS
From date of starting treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months.
Measured: 6months
ORR
Overall Response Rate
Measured: From the first drug administration up to two years
DCR
Disease Control Rate
Measured: From the first drug administration up to two years
Complete ablation rate
The complete ablation rate was evaluated by abdominal enhanced MRI or CT at 4 weeks after operation
Measured: From the first drug administration up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Cancer Metastatic to LiverStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677192
- Sponsor's protocol ID
- PCLM-A 2020
- Status last verified
- Dec 2020
- First submitted
- 17 Dec 2020
- Last updated
- 21 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
PubMed 26808342Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902Pelzer U, Opitz B, Deutschinoff G, Stauch M, Reitzig PC, Hahnfeld S, Muller L, Grunewald M, Stieler JM, Sinn M, Denecke T, Bischoff S, Oettle H, Dorken B, Riess H. Efficacy of Prophylactic Low-Molecular Weight Heparin for Ambulatory Patients With Advanced Pancreatic Cancer: Outcomes From the CONKO-004 Trial. J Clin Oncol. 2015 Jun 20;33(18):2028-34. doi: 10.1200/JCO.2014.55.1481. Epub 2015 May 18.
PubMed 25987694Frampas E, David A, Regenet N, Touchefeu Y, Meyer J, Morla O. Pancreatic carcinoma: Key-points from diagnosis to treatment. Diagn Interv Imaging. 2016 Dec;97(12):1207-1223. doi: 10.1016/j.diii.2016.07.008. Epub 2016 Aug 24.
PubMed 27567314Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.
PubMed 26830752Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
PubMed 24131140Tahara J, Shimizu K, Otsuka N, Akao J, Takayama Y, Tokushige K. Gemcitabine plus nab-paclitaxel vs. FOLFIRINOX for patients with advanced pancreatic cancer. Cancer Chemother Pharmacol. 2018 Aug;82(2):245-250. doi: 10.1007/s00280-018-3611-y. Epub 2018 May 30.
PubMed 29846765Yu X, Gu J, Fu D, Jin C. Dose surgical resection of hepatic metastases bring benefits to pancreatic ductal adenocarcinoma? A systematic review and meta-analysis. Int J Surg. 2017 Dec;48:149-154. doi: 10.1016/j.ijsu.2017.10.066. Epub 2017 Nov 6.
PubMed 29081375Frigerio I, Regi P, Giardino A, Scopelliti F, Girelli R, Bassi C, Gobbo S, Martini PT, Capelli P, D'Onofrio M, Malleo G, Maggino L, Viviani E, Butturini G. Downstaging in Stage IV Pancreatic Cancer: A New Population Eligible for Surgery? Ann Surg Oncol. 2017 Aug;24(8):2397-2403. doi: 10.1245/s10434-017-5885-4. Epub 2017 May 17.
PubMed 28516291Hackert T, Niesen W, Hinz U, Tjaden C, Strobel O, Ulrich A, Michalski CW, Buchler MW. Radical surgery of oligometastatic pancreatic cancer. Eur J Surg Oncol. 2017 Feb;43(2):358-363. doi: 10.1016/j.ejso.2016.10.023. Epub 2016 Nov 9.
PubMed 27856064Park JB, Kim YH, Kim J, Chang HM, Kim TW, Kim SC, Kim PN, Han DJ. Radiofrequency ablation of liver metastasis in patients with locally controlled pancreatic ductal adenocarcinoma. J Vasc Interv Radiol. 2012 May;23(5):635-41. doi: 10.1016/j.jvir.2012.01.080.
PubMed 22525021Lee SJ, Kim JH, Kim SY, Won HJ, Shin YM, Kim PN. Percutaneous Radiofrequency Ablation for Metachronous Hepatic Metastases after Curative Resection of Pancreatic Adenocarcinoma. Korean J Radiol. 2020 Mar;21(3):316-324. doi: 10.3348/kjr.2019.0647.
PubMed 32090524
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety Evaluation of Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis: A Prospective, Single-center, Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT04677192
- Acronym / sponsor ID
- PCLM-A 2020
- Keywords
- Pancreatic Cancer Metastatic to Liver, Oligometastasis, Microwave Ablation, overall survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Dec 2020 (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.
This study is a prospective, single center, single arm, phase II clinical study in patients with liver metastasis after radical resection of pancreatic cancer. The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.
Detailed description
Microwave ablation, as one of the important treatment methods of liver metastases, has the advantages of radical effect, small trauma and rapid recovery.Microwave ablation combined with chemotherapy aims to improve the quality of life and prolong the survival time.The purpose of this study is to evaluate the clinical value of microwave ablation combined with chemotherapy for liver metastasis after radical resection of pancreatic cancer about overall survival, and to determine the feasibility and safety of the scheme.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microwave Ablation Combined with Chemotherapy | Experimental | Combination Product: Microwave Ablation combination with chemotherapyAll patients will receive microwave ablation of oligohepatic metastasis and chemotherapy according to NCCN guidelines,and the efficacy was evaluated every 8 weeks until the disease progressed or the patient could not tolerate it. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age: 18 to 75years old, male or female;
- ECOG PS: 0-2 points;
- Patients with pancreatic ductal adenocarcinoma diagnosed by histology or cytology;
- Expected survival time> 3 months;
- The functions of important organs meet the following requirements;
Key exclusion criteria (6 listed)
- Patients with distant metastasis include but not limited to lung metastasis, bone metastasis and brain metastasis;
- Other serious diseases or conditions, including congestive heart failure (NYHA grade III or IV), unstable angina, myocardial infarction and cerebral infarction in the past 6 months, severe arrhythmia, prolonged QT interval, active HIV infection or HIV disease, mental disorders, drug abuse, etc;
- Women who are pregnant or nursing, or have fertility but refuse to take contraceptive measures;
- During the enrollment period, a serious active infection requiring antibiotic intravenous treatment occurred;
- In addition to cervical carcinoma in situ, basal cell carcinoma and superficial bladder tumor (TA, tis \& T1). Any cancer cured for more than 3 years before enrollment was allowed to be enrolled;
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 |
|---|---|---|
| Microwave Ablation combination with chemotherapyMicrowave Ablation combination with chemotherapy. Maximum tumor diameter ≤ 3cm, single microwave needle, maximum tumor diameter> 3cm, double ablation needle, the ablation range completely covers the lesion ≥ 0.5cm in order to obtain a satisfactory ablation margin. After the operation, contrast ultrasound is performed again to confirm the ablation edge. Enhanced MRI or CT to evaluate the ablation effect 4 weeks after surgery. Selection of chemotherapy regimen refers to the 2020 NCCN Guidelines for Pancreatic Cancer. First-line chemotherapy regimen: gemcitabine combined with albumin-bound paclitaxel or FOLFIRINOX; second-line chemotherapy regimen: If first-line chemotherapy based on gemcitabine, 5-FU-based regimen for second-line, If 5-FU-based regimen for first-line, gemcitabine for second-line. | Combination product | Microwave Ablation Combined with Chemotherapy |
Primary outcome
OS
Time frame: 24months
Overall survival
4 secondary outcomes
6-month PFS
Time frame: 6months
ORR
Time frame: From the first drug administration up to two years
DCR
Time frame: From the first drug administration up to two years
Complete ablation rate
Time frame: From the first drug administration up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2020.
- Background: PubMed 26808342Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Background: PubMed 25987694Pelzer U, Opitz B, Deutschinoff G, Stauch M, Reitzig PC, Hahnfeld S, Muller L, Grunewald M, Stieler JM, Sinn M, Denecke T, Bischoff S, Oettle H, Dorken B, Riess H. Efficacy of Prophylactic Low-Molecular Weight Heparin for Ambulatory Patients With Advanced Pancreatic Cancer: Outcomes From the CONKO-004 Trial. J Clin Oncol. 2015 Jun 20;33(18):2028-34. doi: 10.1200/JCO.2014.55.1481. Epub 2015 May 18.
- Background: PubMed 27567314Frampas E, David A, Regenet N, Touchefeu Y, Meyer J, Morla O. Pancreatic carcinoma: Key-points from diagnosis to treatment. Diagn Interv Imaging. 2016 Dec;97(12):1207-1223. doi: 10.1016/j.diii.2016.07.008. Epub 2016 Aug 24.
- Background: PubMed 26830752Kamisawa T, Wood LD, Itoi T, Takaori K. Pancreatic cancer. Lancet. 2016 Jul 2;388(10039):73-85. doi: 10.1016/S0140-6736(16)00141-0. Epub 2016 Jan 30.
- Background: PubMed 24131140Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
- Background: PubMed 29846765Tahara J, Shimizu K, Otsuka N, Akao J, Takayama Y, Tokushige K. Gemcitabine plus nab-paclitaxel vs. FOLFIRINOX for patients with advanced pancreatic cancer. Cancer Chemother Pharmacol. 2018 Aug;82(2):245-250. doi: 10.1007/s00280-018-3611-y. Epub 2018 May 30.
- Background: PubMed 29081375Yu X, Gu J, Fu D, Jin C. Dose surgical resection of hepatic metastases bring benefits to pancreatic ductal adenocarcinoma? A systematic review and meta-analysis. Int J Surg. 2017 Dec;48:149-154. doi: 10.1016/j.ijsu.2017.10.066. Epub 2017 Nov 6.
- Background: PubMed 28516291Frigerio I, Regi P, Giardino A, Scopelliti F, Girelli R, Bassi C, Gobbo S, Martini PT, Capelli P, D'Onofrio M, Malleo G, Maggino L, Viviani E, Butturini G. Downstaging in Stage IV Pancreatic Cancer: A New Population Eligible for Surgery? Ann Surg Oncol. 2017 Aug;24(8):2397-2403. doi: 10.1245/s10434-017-5885-4. Epub 2017 May 17.
- Background: PubMed 27856064Hackert T, Niesen W, Hinz U, Tjaden C, Strobel O, Ulrich A, Michalski CW, Buchler MW. Radical surgery of oligometastatic pancreatic cancer. Eur J Surg Oncol. 2017 Feb;43(2):358-363. doi: 10.1016/j.ejso.2016.10.023. Epub 2016 Nov 9.
- Background: PubMed 22525021Park JB, Kim YH, Kim J, Chang HM, Kim TW, Kim SC, Kim PN, Han DJ. Radiofrequency ablation of liver metastasis in patients with locally controlled pancreatic ductal adenocarcinoma. J Vasc Interv Radiol. 2012 May;23(5):635-41. doi: 10.1016/j.jvir.2012.01.080.
- Background: PubMed 32090524Lee SJ, Kim JH, Kim SY, Won HJ, Shin YM, Kim PN. Percutaneous Radiofrequency Ablation for Metachronous Hepatic Metastases after Curative Resection of Pancreatic Adenocarcinoma. Korean J Radiol. 2020 Mar;21(3):316-324. doi: 10.3348/kjr.2019.0647.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Microwave Ablation combination with chemotherapy in people with Pancreatic Cancer Metastatic to Liver and Oligometastasis, run by Fudan University at 1 site in China.
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 14 inclusion and 6 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 21 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yongqiang Hua, Deputy chief physician (（021）64175590 ext. 73915, keqiang1215@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS (time frame: 24months). 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 NCT04677192, which also lists 12 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 21 Dec 2020.