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Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate the efficacy of thalidomide on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• Ability to understand and the willingness to sign a written informed consent document.

• Age ≥ 18 years and ≤ 80 years.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

• Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.

• Adequate organ performance based on laboratory blood tests.

• Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

• The expected survival ≥ 3 months.

• Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Locations
Other Locations
China
Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Ying Yang, MD
yangying@fudanpci.org
86 64175590
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 100
Treatments
Experimental: Chemotherapy + Thalidomide
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Thalidomide 100 mg/day, once a day, orally intake at night.
Active_comparator: Chemotherapy
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.~placebo 100 mg/day, once a day, orally intake at night.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov