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Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers

NCT03162510 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-04-07

No results posted yet for this study

Summary

The primary purpose of the study is to determine the maximal tolerated dose (MTD) of Oxaliplatin in this phase I study. The secondary objectives are to determine the response rate, progression free survival, overall survival, and safety profiles.

Eligible patients will receive a triplet chemotherapy consisting of nab-paclitaxel (Abraxane®) 150 mg/m2 IVD 30 min followed by Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, plus oral S-1 35mg/m2 and Leucovorin 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression.

Conditions

  • Gastric Cancer in Situ
  • Pancreatic Cancers
  • Biliary Cancers

Interventions

DRUG

Oxaliplatin

Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, every 14 days as a cycle till disease progression

DRUG

Albumin-Bound Paclitaxel /nab-Paclitaxel

150 mg/m2 IVD 30 min bi-weekly.

DRUG

S-1

Tegafur,oral S-1 35mg/m2 twice daily from D1 to D7, every 14 days as a cycle till disease progression.

DRUG

LV

LV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • National Taiwan University Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Li-Tzong Chen, MD PHD · National Health Research Institutes, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2021-06-07
Completion
2022-01-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03162510 on ClinicalTrials.gov