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

Primary Purpose

Pancreatic Cancer Metastatic to Liver, Oligometastasis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Microwave Ablation combination with chemotherapy
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer Metastatic to Liver focused on measuring Pancreatic Cancer Metastatic to Liver, Oligometastasis, Microwave Ablation, overall survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

    1. Platelet ≥75×109/L, hemoglobin ≥85g/L,white blood cell ≥ 3.0 × 109 / L;
    2. Total bilirubin ≤ 1.5 times upper limit of normal value (ULN) ; ALT and AST ≤ 5 times ULN ;
    3. Albumin ≥ 28g / L;
    4. 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.

Exclusion Criteria:

  • 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;

Sites / Locations

  • Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microwave Ablation Combined with Chemotherapy

Arm Description

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.

Outcomes

Primary Outcome Measures

OS
Overall survival

Secondary Outcome Measures

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.
ORR
Overall Response Rate
DCR
Disease Control Rate
Complete ablation rate
The complete ablation rate was evaluated by abdominal enhanced MRI or CT at 4 weeks after operation

Full Information

First Posted
December 17, 2020
Last Updated
December 17, 2020
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT04677192
Brief Title
Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer Metastatic to Liver, Oligometastasis
Keywords
Pancreatic Cancer Metastatic to Liver, Oligometastasis, Microwave Ablation, overall survival

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Microwave Ablation Combined with Chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Microwave Ablation combination with chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
OS
Description
Overall survival
Time Frame
24months
Secondary Outcome Measure Information:
Title
6-month PFS
Description
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.
Time Frame
6months
Title
ORR
Description
Overall Response Rate
Time Frame
From the first drug administration up to two years
Title
DCR
Description
Disease Control Rate
Time Frame
From the first drug administration up to two years
Title
Complete ablation rate
Description
The complete ablation rate was evaluated by abdominal enhanced MRI or CT at 4 weeks after operation
Time Frame
From the first drug administration up to two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongqiang Hua, Deputy chief physician
Phone
(021)64175590
Ext
73915
Email
keqiang1215@126.com
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

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

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