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Microwave ablation combined with chemotherapy in the treatment of pancreatic cancer with oligohepatic metastasis: a prospective, single-center, single-arm phase II clinical study

MWA combined with chemotherapy in the treatment of pancreatic cancer with oligohepatic metastasis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041803
Enrollment
Unknown
Registered
2021-01-06
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

MWA combined with chemotherapy group:MWA combined with chemotherapy

Sponsors

Shanghai Tumor Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-75, male or female; 2. Subjects with ECoG score of 0-2; 3. Patients with pancreatic ductal adenocarcinoma confirmed by histology or cytology; 4. Subjects meeting the requirements of oligometastasis: the maximum diameter of single lesion = 75 * 10^9 / L, hemoglobin >= 85g / L, white blood cell >= 3.0 * 10^9 / L; total bilirubin = 28g / L; serum creatinine = 50ml / min; 7. The subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up; 8. Patients whose expected survival period is more than 3 months; 9. Women of childbearing age must have pregnancy test within 7 days before treatment and the result is negative; men of childbearing age: take effective contraceptive measures during treatment and within 3 months after treatment; 10. Subjects 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 can be enrolled.

Exclusion criteria

Exclusion criteria: 1. Patients with distant metastasis, including but not limited to lung metastasis, bone metastasis and brain metastasis; 2. Patients with other serious diseases or conditions, including congestive heart failure (NYHA grade III or IV), unstable angina pectoris, 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.; 3. Patients complicated with infection who need intravenous antibiotics; 4. Pregnant or lactating women. Women of childbearing age who are unwilling or unable to use an acceptable method of contraception during the whole treatment period of this trial and within 12 weeks after the last administration of the study drug. If the partner is a woman of childbearing age, the male who is sexually active and fertile and does not take effective contraceptive measures; 5. In the past or at the same time, the patients with primary tumor or cancer whose histology is completely different from that of intrahepatic cholangiocarcinoma, except for cervical cancer in situ, basal cell carcinoma previously treated and superficial bladder tumor (TA, tis & T1). Any cancer cured for more than 3 years before inclusion was allowed to be enrolled; 6. Patients with poor compliance.

Design outcomes

Secondary

MeasureTime frame
6 months of Progression-free Survival;Objective Response Rate, ORR;Disease Control Rate, DCR;Complete ablation rate;Secondary ablation rate;The incidence of grade 3-4 adverse reactions;Quality of life (QOL);

Primary

MeasureTime frame
overall survival;

Countries

China

Contacts

Public ContactHua Yongqiang

Shanghai Tumor Hospital affiliated to Fudan University

keqiang1215@126.com+86 18017317566

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026