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

NCT04677192 | Unknown Phase 2 DMC

• 1 other identifier: PCLM-A 2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer Metastatic to Liver; Oligometastasis

Keywords

Pancreatic Cancer Metastatic to Liver; Oligometastasis; Microwave Ablation; overall survival

Outcome Measures

Primary Outcomes (1)

• OS

  Overall survival

  24months

Secondary Outcomes (4)

• 6-month PFS

  6months

• ORR

  From the first drug administration up to two years

• DCR

  From the first drug administration up to two years

• Complete ablation rate

  From the first drug administration up to two years

Study Arms (1)

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.

Combination Product: Microwave Ablation combination with chemotherapy

Interventions

Microwave Ablation combination with chemotherapy COMBINATION_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.

Microwave Ablation Combined with Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (12)

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  PMID: 32090524 BACKGROUND

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Yongqiang Hua, Deputy chief physician

CONTACT

（021）64175590; keqiang1215@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 21, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

CN (1)