Clinical trial · Interventional
Microwave Ablation Combined With Chemotherapy in the Treatment of Pancreatic Cancer Oligohepatic Metastasis
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligometastasis | — | UNRESOLVED | — |
| Pancreatic Cancer Metastatic to Liver | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microwave Ablation combination with chemotherapy | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Microwave Ablation Combined with Chemotherapy
- 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.
- interventionNames
- Combination Product: Microwave Ablation combination with chemotherapy
Primary outcomes (1)
- measure
- OS
- timeFrame
- 24months
- description
- Overall survival
Secondary outcomes (4)
- measure
- 6-month PFS
- timeFrame
- 6months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (12)
- BACKGROUNDChen 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. PMID 26808342
- BACKGROUNDSiegel 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. PMID 31912902
- BACKGROUNDPelzer 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. PMID 25987694
- BACKGROUNDFrampas 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. PMID 27567314
- BACKGROUNDKamisawa 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. PMID 26830752
- BACKGROUNDVon 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. PMID 24131140
- BACKGROUNDTahara 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.