Microwave Ablation Combined With Chemotherapy In The Treatment Of Pancreatic Cancer Oligohepatic Metastasis

Study Overview

Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis

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.

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.

Pancreatic Cancer Metastatic to Liver
Oligometastasis

COMBINATION_PRODUCT: Microwave Ablation combination with chemotherapy

PCLM-A 2020

Study Record Dates

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
First Submitted 2020-12-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-12-17
First Submitted that Met QC Criteria 2020-12-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-12-21
First Posted (ACTUAL) 2020-12-21	Results First Posted N/A	Last Verified 2020-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Microwave Ablation Combined with Chemotherapy 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.	COMBINATION_PRODUCT: Microwave Ablation combination with chemotherapy 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 ablatio

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Microwave Ablation Combined with Chemotherapy

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.

COMBINATION_PRODUCT: Microwave Ablation combination with chemotherapy

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 ablatio

Primary Outcome Measures	Measure Description	Time Frame
OS	Overall survival	24months

Secondary Outcome Measures	Measure Description	Time Frame
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.	6months
ORR	Overall Response Rate	From the first drug administration up to two years
DCR	Disease Control Rate	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	From the first drug administration up to two years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yongqiang Hua, Deputy chief physician

Phone Number: （021）64175590

Email: keqiang1215@126.com

Participation Criteria

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:

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;
Measurable lesions that meet RECIST criteria.

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.

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;

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.
Siegel 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.
Pelzer 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.
Frampas 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.
Kamisawa 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.
Von 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.
Tahara 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.
Yu 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.
Frigerio 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.
Hackert 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.
Park 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.
Lee 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.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record