Thalidomide for Nausea from Chemotherapy in Pancreatic Cancer
Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer
Recruiting
Phase 3Interventional Study
Pancreatic Cancer Stage IVChemotherapy-induced Nausea and Vomiting
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for
This trial is looking for patients with stage IV pancreatic cancer who have nausea from chemotherapy. Participants will take thalidomide to see if it helps improve their quality of life during treatment.
Are You a Good Fit for This Trial?
Rules you outNon-adenocarcinoma of pancreasPancreatitis
You may be able to join if
I am between 18 and 80 years old.
I have been diagnosed with metastatic pancreatic adenocarcinoma.
I can understand and sign a consent form.
I have a performance status of 0-2.
I have at least one measurable tumor.
My expected survival is at least 3 months.
I will use contraception if I am able to have children.
You may not be able to join if
I have received any anti-tumor treatment before this study.
I am pregnant or nursing.
I have severe diseases that affect my health.
I have a history of severe allergic reactions to similar drugs.
I have uncontrolled diabetes.
I have had a heart attack in the past 6 months.
I am not able to follow the study procedures.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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.
* Adequat…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Patients who have received any form of anti-tumor therapy.
* The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
* Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
* Pregnant or nursing women.
* Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc).
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study.
* Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
* Patients who are unwilling or unable to comply with study procedures.
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