Phase I/II study of GnPipPTX
- Conditions
- Pancreatic cancer patients with peritoneal metastasisPancreatic cancer, Peritoneal metastasis
- Registration Number
- JPRN-jRCTs031180095
- Lead Sponsor
- akai Yousuke
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 44
1. Histologically or cytologically proven pancreatic adenocarcinoma
2. No previous antitumor treatment other than surgery and adjuvant chemotherapy
3. Peritoneal metastasis confirmed by diagnostic imaging, staging laparoscopy or laparotomy within 14 days before secondary registration
4. Adequate organ functions(according to the laboratory data which was taken within 7 days before primary registration)
5. Eastern Cooperative Oncology Group performance status 0-1
6. Aged 20<=, 75> years old
7. Oral intake
8. Written informed consent
1. Contraindication for gemcitabine, nab-paclitaxel or paclitaxel
2. Other active concomitant malignancies at primary registration
3. Allergy to iodine or gadolinium contrast agent
4. Blood transfusion or use of G-CSF within 7 days beforeprimary registration
5. Past or current severe heart disease, liver cirrhosis, active GI ulcers or obstruction
6. Severe complications such as interstitial pneumonitis, pulmonary fibrosis
7. Uncontrollable diabetes mellitus
8. Grade 3/4 of sensory neuropathy
9. Active infection rather than HBV/HCV
10.Clinically apparent mental or central nerve disorders
11. Pregnant or nursing women
12. Judged to be unfit to participate in this study by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I ; Dose limiting toxicity, <br>Phase II; Overall survival
- Secondary Outcome Measures
Name Time Method Phase I ; Safety, <br>Phase II; Response rate, Safety, Progression-free survival, Treatment completion rate, Negative conversion rate on peritoneal cytology