Divestment for Artery-involved Pancreatic Cancer

Nanjing Medical University

Status: Unknown

Conditions: Locally Advanced Pancreatic Cancer; Borderline Resectable Pancreatic Cancer; Neoadjuvant Therapy; Pancreatic Cancer

Treatments: Procedure: Artery Divestment Technique; Drug: Nab-paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT03443921

NMU-JSPH-PC-DIV

Details and patient eligibility

About

Pancreatic cancer is the most lethal malignancy of human being. Surgery is the only potential cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. For artery-involved pancreatic cancer (ai-PC) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy, has brought exciting postoperative survival. Yet due to the potential screening effect of this treatment strategy, nearly half of ai-PC patients failed to benefit from surgery because of disease progression, adverse reactions of adjuvant treatment and other reasons. Artery divestment for the treatment of ai-PC firstly reported by our center, can significantly increase resection rate and produce overall survival benefit in some patients. This study is to explore whether up-front surgery with artery divestment combined curative pancreatectomy or the chemotherapy-first strategy would be more beneficial for ai-PC patients' survival.

Subjects will be randomized to treatment group either receiving up-front artery divestment combined pancreatectomy (Surgery Group) or adjuvant chemotherapies (Chemo Group). In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. In Chemo Group, adjuvant chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to performance status. After 2 circles of adjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.

Overall mortality at one year after randomization will be the primary endpoint. Other parameters as overall survival after 2 and 3 years, median survival, disease-free survival, margin status of subjects receiving curative surgery, etc. will also be observed.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with pancreatic cancer staged at cT4NxM0(AJCC Cancer Staging Manual, 8th Edition) based on contrast enhanced CT&MRI scan and tumor markers;
2. Age > 18 year and <80 year;
3. Agree to participate in the study with signed informed consent.

Exclusion criteria

1. Evidence of metastasis based on physical examination, enhanced CT or enhanced MRI;
2. Poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy;
3. Focal vessel narrowing or contour irregularity revealed by radiology examinations;
4. Economic situations cannot afford designed treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Surgery Group

Experimental group

Description:

In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status.

Treatment:

Procedure: Artery Divestment Technique

NeoChemo Group

Active Comparator group

Description:

In NeoChemo (Neoadjuvant Chemotherapy) Group, neoadjuvant chemotherapy will be utilized. After 2 circles of neoadjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.

Treatment:

Drug: Nab-paclitaxel