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AzTrials

Pancreatic Cancer Stage IVPhase 3PTCA199-5NCT06017284

Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer

A Phase 3 study testing Thalidomide, Nab paclitaxel and Gemcitabine in people with Pancreatic Cancer Stage IV and Chemotherapy-induced Nausea and Vomiting, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Thalidomide, Nab paclitaxel and Gemcitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteChina
Study dates
1 Nov 2023to 30 Nov 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ying Yang, MD contact

86 64175590 ext. 1307

yangying@fudanpci.org

China1 site, 1 recruiting

  • Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Ying Yang, MD, 86 21 64175590 ext. 1307, yangying@fudanpci.org

    Recruiting

Other trials in China

About this study

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.

Read the detailed description

Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. The Metastatic Pancreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to gemcitabine combined with nab-paclitaxel including nausea/vomiting, insomnia, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen.

Thalidomide is an oral medication used to treat a number of cancers (e.g. multiple myeloma), graft-versus-host disease, and many skin disorders (e.g. complications of leprosy such as skin lesions). It caused severe malformations in babies born to mothers taking the drug for morning sickness in the late 1950s and early 1960s. Thalidomide works on the immune system to reduce inflammation. Thalidomide may enhance the tolerability of chemotherapy by reducing nausea/vomiting, improving sleeping quality, alleviating pain, and thus improving quality of life for patients with pancreatic cancer.

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. One hundred patients will be randomly assigned to the experimental group (gemcitabine combined with nab-paclitaxel, Thalidomide) or the control group (gemcitabine combined with nab-paclitaxel). Rate of nausea/vomiting, index of sleep quality, severity of pain, quality of life, and overall survival are measured every four weeks.

Being tested
Thalidomide, Nab paclitaxel, Gemcitabine, Placebo
Keywords
chemotherapy, pancreatic cancer, Thalidomide, nausea, quality of life
Medical subject headings
Pancreatic Neoplasms, Vomiting, Nausea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ThalidomideDrug

    Thalidomide 100 mg/day, once a day, orally intake at night.

  • Nab paclitaxelDrug

    nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks.

  • GemcitabineDrug

    gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.

  • PlaceboDrug

    Placebo, 100 mg/day, once a day, orally intake at night.

Study groups in NCT06017284
Study groupRoleWhat they receive
Chemotherapy + ThalidomideExperimentalnab-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.
Receives: Drug: Thalidomide; Drug: Nab paclitaxel; Drug: Gemcitabine
ChemotherapyActive comparatornab-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.
Receives: Drug: Nab paclitaxel; Drug: Gemcitabine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of nausea/vomiting

    Rate of nausea/vomiting after every cycle of chemotherapy using the 4-point Likert scale. The range of scale is 0-3 and higher scores mean a worse outcome.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

Secondary outcomes (4)

  1. Pain numeric rating scale (NRS)

    Change of pain numeric rating scale after every cycle of chemotherapy. The administration of analgesic drugs after every cycle of chemotherapy is recorded. The range of NRS scale is 0-10 and higher scores mean a worse outcome.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. Quality of life (QOL)

    Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  3. Sleep quality index

    Sleep quality index after every cycle of chemotherapy is assessed using Pittsburgh sleep quality index (PSQI)

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  4. Overall survival (OS)

    OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start1 Nov 2023
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06017284
Sponsor's protocol ID
PTCA199-5
Acronym
PTCA199-5
Status last verified
Nov 2023
First submitted
24 Aug 2023
Last updated
24 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang L, Qu X, Teng Y, Shi J, Yu P, Sun T, Wang J, Zhu Z, Zhang X, Zhao M, Liu J, Jin B, Luo Y, Teng Z, Dong Y, Wen F, An Y, Yuan C, Chen T, Zhou L, Chen Y, Zhang J, Wang Z, Qu J, Jin F, Zhang J, Jin X, Xie X, Wang J, Man L, Fu L, Liu Y. Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study). J Clin Oncol. 2017 Nov 1;35(31):3558-3565. doi: 10.1200/JCO.2017.72.2538. Epub 2017 Aug 30.

    PubMed 28854065

  • Hwu WJ, Krown SE, Menell JH, Panageas KS, Merrell J, Lamb LA, Williams LJ, Quinn CJ, Foster T, Chapman PB, Livingston PO, Wolchok JD, Houghton AN. Phase II study of temozolomide plus thalidomide for the treatment of metastatic melanoma. J Clin Oncol. 2003 Sep 1;21(17):3351-6. doi: 10.1200/JCO.2003.02.061.

    PubMed 12947072

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Thalidomide, Nab paclitaxel and Gemcitabine in people with Pancreatic Cancer Stage IV and Chemotherapy-induced Nausea and Vomiting, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ying Yang, MD (86 64175590 ext. 1307, yangying@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of nausea/vomiting (time frame: At the end of Cycle 1 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06017284, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.

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