NCT06017284

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
7mo left

Started Nov 2023

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Nov 2023Nov 2026

First Submitted

Initial submission to the registry

August 24, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Expected
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

August 24, 2023

Last Update Submit

November 21, 2023

Conditions

Pancreatic Cancer Stage IVChemotherapy-induced Nausea and Vomiting

Keywords

chemotherapypancreatic cancerThalidomidenauseaquality of life

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

  • Pain numeric rating scale (NRS)

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

  • Quality of life (QOL)

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

  • Sleep quality index

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

  • Overall survival (OS)

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

Study Arms (2)

Chemotherapy + Thalidomide

EXPERIMENTAL

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.

Drug: ThalidomideDrug: Nab paclitaxelDrug: Gemcitabine

Chemotherapy

ACTIVE COMPARATOR

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.

Drug: Nab paclitaxelDrug: GemcitabineDrug: Placebo

Interventions

ThalidomideDRUG

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

Chemotherapy + Thalidomide
Nab paclitaxelDRUG

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

ChemotherapyChemotherapy + Thalidomide
GemcitabineDRUG

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

ChemotherapyChemotherapy + Thalidomide
PlaceboDRUG

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

Chemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28854065BACKGROUND

  • 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.

    PMID: 12947072BACKGROUND

MeSH Terms

Conditions

Pancreatic NeoplasmsVomitingNausea

Interventions

ThalidomideTaxesGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingEconomicsHealth Care Economics and OrganizationsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidines

Study Officials

  • Guopei Luo, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Yang, MD

CONTACT

86 64175590yangying@fudanpci.org

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 24, 2023

First Posted

August 30, 2023

Study Start

November 1, 2023

Primary Completion

November 30, 2025

Study Completion (Estimated)

November 30, 2026

Last Updated

November 24, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)