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A phase II trial of Down staging Chemotherapy with Nab-paclitaxel plus Gemcitabine in patients with locally advanced pancreatic cancer (CAP-005)

A phase II trial of GnP down staging chemotherapy for patients with locally advanced pancreatic cancer(CAP-005) (CAP-005)

40

Among all 40 participants, they were 24 men (60%), the mean age was 65 years, and 25 patients (62%) showing the primary tumor located in the head of the pancreas.

This trial enrolled 40 patients between May 2016 and Dec 2019. The follow up period of the trial was finished in June 2022. The trial was finalized in Dec 2022. (1) All participants in this study (ITT, FAS n=40) (2) Target cohort that meets the protocol (PPS n=37) (3) The resected cases (n=27) (4) Cases that completed the protocol (n=23)

Of the 40 patients who started neoadjuvant treatment, 24 (62%) completed the planned 3 cycles of GnP chemotherapy. All patients were assessable for adverse events. One patient (2.5%) died due to sepsis with liver abscess infected by clostridium perfringens. The G3/4 toxicity was occurred in 19 patients (47.5%). In terms of hematological toxicity, neutropenia was commonly noted for grade 3/4 (n = 15; 37.5%) events. Increase of liver enzyme was occurred in 7.5%. Severe non-hematological toxicity (CG3) was infrequent, namely, diarrhea (2.5%) and fatigue (2.5%).

Primary outcomes R0 resection rate:(1) 22/40 (55.0%) in the FAS (3) 21/27 (77.8%) in the resected cases (4) 20/23 (87.0%) for on-protocol Secondary outcomes resection rate (R0/1) (1) 28/40 (70%) (3) 27/27 (100%) (4) 23/23 (100%) median survival time (MST) of overall survival: (1) 26.6 months (3) 39.8 months (4) 39.8 months MST of progression free survival: (1) 16.7 months MST of disease free survival: (3) 16.9 months (4) 16.4 months pathological chemotherapy effect: Evans grade (3) I: 37.0%, IIa: 48.2%, IIb: 11.1%, III: 0%, IV: 3.7% (4) I: 39.1%, IIa: 47.8%, IIb: 8.7%, III: 0%, IV: 4.4% adverse events: 1 missing case, Sepsis (Liver abscess with cholangitis due to infection of clostridium perfringens) complication rate (G3/4): 19/40 (47.5%) tumor marker: normalization rate of CA19-9: (4) 43.5% tumor response rate (RR): (1) 15/40 (37.5%) (3) 14/27 (51.9%) (4) 14/23 (60.9%) the rate of tumor shrinkage (mean+/-SD): (3) 72.3+/-19.5%, (4) 68.6+/-18.6% relative dose intensity: (4) Gem 97.5%, nab-PTX 97.4% rate of protocol completion: (4) 23/40 (57.5%) positive rate of lymph node: (3) 20/27 (74.1%) (4) 17/23 (73.9%)

A phase II trial of Down staging Chemotherapy with Nab-paclitaxel plus Gemcitabine in patients with locally advanced pancreatic cancer was conducted. Of all 40 participants, the G3/4 toxicity was occurred in 19 patients (47.5%). In terms of hematological toxicity, neutropenia was commonly noted for grade 3/4 (n = 15; 37.5%) events. In terms of efficacy of down-staging GnP therapy, R0 rate (as the primary endpoint) was 55.0% in the FAS, 77.8% in the resected cases, and 87.0% in the on-protocol cohort.

June. 30, 2023

No

None

https://jrct.niph.go.jp/latest-detail/jRCTs031180318

Ohtsuka Masayuki

Chiba University Hospital

1-8-1, Inohana, Cyuoku, Chiba

otsuka-m@faculty.chiba-u.jp

Takano Shigetsugu

Chiba University Hospital

1-8-1, Inohana, Cyuoku, Chiba

+81-43-222-7171

stakano@faculty.chiba-u.jp

Complete

May. 23, 2016

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1. Invasive ductal carcinoma or invasive intraductal papillary-mucinous carcinoma proved by radiological examination (enhanced CT or MRI)
2. No distant metastasis
3. Borderline or unresectable locally advanced pancreatic cancer tumor abutment of the SMA,CHA,CEA tumor involving PV or SMV diameter of encased PV or SMV are less than 50% of adjacent normal PV or SMV diameter.
4. patients who can tolerate the pancreatic surgery.
5. Age more than 20 or less than 80
6. No history of primary chemotherapy and/or radiation therapy.
7. ECOG performance status 0-1
8. Adequate organ function
9. Without problems for oral medication
10. Written informed consent

1. History of severe allergic reaction with gemcitabine, nab-paclitaxel or S-1
2. Pregnant females, possibly pregnant females, females wishing to become pregnant, and females feeding babies.
3. Pulmonary fibrosis or interstitial pneumonia
4. History of breast or lung radiation
5. Active infection
6. Patients with pleural effusion
7. Active double cancer
8. Patients with positive for HBs antigen
9. Patients under treatment with phenytoin or walfarin
10. Uncontrolled heart diseases such as angina, myocardial infarction within three months,and cardiac dysfunction
11. Uncontrolled diabetes or hypertension
12. Sever mental disorder
13. Inadequate physical condition, as diagnosed by primary physician

Both

Pancreatic cancer

1)Down staging chemotherapy: 3 course of gemcitabine and nab-PTX combination therapy (21days for one course:day1, day8 nab-PTX:125mg/m2/day+GEM:1000mg/m2/day) or total six times administration
2)Surgical resection
3)Adjuvant therapy: 4 course of S-1 monotherapy (42days for one course:day1-28 S-1 80mg/m2)

084

R0 resection rate

resection rate (R0+1), overall survival, disease free survival, pathological chemotherapy effect, adverse events, complication rate, tumor marker, tumor response rate, relative dose intensity, rate of protocol achievement, recurrence type, positive rate of lymph node metastasis

+81-43-226-2616

Mar. 04, 2019

none