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A multi-center, open-label, prospective trial for S-1 plus nab-paclitaxel or Gemcitabine as the first-line chemotherapy for unresctable pancreatic cancer (AvGmPC)

A multi-center, open-label, prospective trial for S-1 plus nab-paclitaxel or Gemcitabine as the first-line chemotherapy for unresctable pancreatic cancer (AvGmPC)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024588
Enrollment
Unknown
Registered
2019-07-18
Start date
2019-07-30
Completion date
Unknown
Last updated
2019-07-22

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

Conditions

pancreatic cancer

Interventions

AS:S-1+ nab-paclitaxel
GS:S-1+ Gemcitabine

Sponsors

Zhongshan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Male and female aged 18 to 75 years previously untreated pancreatic cancer patients who lost the chance of radical surgery, including local advanced and metastatic cancers; 2. Histologically or cytologically proven pancreatic adenocarcinoma; 3. For recurrence cases, the relapse must have >=6 months space from the last adjuvant chem; 4. Measurable disease according to the RECIST1.1; 5. ECOG/PS 0-1; 6. Estimated survive >=12 weeks.

Exclusion criteria

Exclusion criteria: 1. Prior palliative chemotherapy; 2. Central nervous system metastases; 3. Ascites, significant; 4. Other malignant cancer in recent 5 years; 5. Serious CVD, DM or middle-high organ function impairment; 6. Upper alimentary tract obstruction (S-1 p.o); 7. Uncontrolled infections; 8. Warfarin using (interfere S-1 drug metabolism); 9. Peripheral neuropathy NCI = G2 (nab-Paclitaxel toxicity).

Design outcomes

Secondary

MeasureTime frame
OS;ORR;DCR;AEs;

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactZhou Yuhong; Lou Wenhui

Zhongshan Hospital, Fudan University

zhou.yuhong@zs-hospital.sh.cn+86 13918286810

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026