To hear about similar clinical trials, please enter your email below
Trial Title:
A Real World Study of Regogfinib in HCC
NCT ID:
NCT05557656
Condition:
Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Conditions: Keywords:
Hepatocellular Carcinoma
Regorafenib
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Regorafenib 40 MG
Description:
participants who received the treatment of Regorafenib
Arm group label:
HCC participants who received the treatment of Regorafenib
Other name:
Regorafenib
Summary:
This is a non-interventional observational study with the primary objective of assessing
the efficacy of regorafenib in patients with immediate or advanced stage HCC.
Detailed description:
1. Study Objectives Primary Objective: To assess the efficacy of regorafenib in
patients with immediate or advanced stage HCC Secondary objective: To assess the
safety of regorafenib in patients with immediate or advanced stage HCC
2. Study Design This is a multicenter, retrospective, real-world study that will
collect data from patients treated with regorafenib at medical centers in China.
3. Data Collection 3.1 Screening Period
The study procedures to be performed at screening include:
1. . Determine eligible subjects according to the inclusion/exclusion criteria and
document the results.
2. . Collect demographic characteristics (eg, age, sex, weight, BMI, and ECOG score);
3. . Collect past medical history;
4. . Collect primary tumor site;
5. . Collect information on prior treatments: all treatments received since diagnosis
of advanced HCC, including each treatment regimen (including first-line therapy),
start and end date, duration, best response;
6. . Collect information on liver function and ECOG score prior to the first dose of
regorafenib;
7. . Collect results of laboratory tests performed prior to and after the first dose of
regorafenib, including haematology, biochemistry and genetic testing (if any);
8. . Collect imaging data: the last imaging procedure performed prior to the first dose
of regorafenib, such as CT, PET-CT, MRI, and whole-body bone scan (with at least 1
measurable lesion); and information related to metastases (such as metastases to
lymph node, bone and/or lung).
3.2 Data Review Period of Regorafenib Treatment
The following information obtained during each cycle of regorafenib will be collected
retrospectively:
1. . Liver function and ECOG score obtained prior to each dose (ie., the first day of
each cycle) of regorafenib;
2. . Initial dose of regorafenib;
3. . Timing and method of dose adjustment, and adjusted doses;
4. . Final daily dose of regorafenib;
5. . Best response, time to best response, and number of treatment cycles;
6. . Imaging findings (including metastatic sites) related to response evaluation;
7. . Hematology laboratory tests (related to the underlying disease, tumor progression,
and ADR);
8. . Any adverse reaction and corresponding CTCAE grade;
9. . Interrupted or discontinued treatment;
10. . The most recent laboratory tests (or alternative doctor's advice and tests)
performed prior to the first day of each treatment cycle, including but not limit to
hematology and biochemistry.
3.3 Progression and Survival Data Collection Period
The following information obtained during each cycle of regorafenib will be collected
retrospectively:
1. . Time to progression
2. . Pattern of progression
3. . Subsequent treatment regimen, dose, number of cycles, efficacy;
4. . Survival status, time of death or last follow-up.
4. Study Drug Generic name: Regorafenib Tablets Trade name: Stivarga® English name:
Regorafenib Tablets
Dosage strength: 40 mg tablet Dosage form: Tablets Description: Oval tablets with
pale-pink film coat Label dose and mode of administration: Recommended dosage is 160 mg,
once daily for the first 21 days of each 28-day cycle. A minimum dose of 80 mg/day and a
maximum dose of 160 mg/day are recommended.
Criteria for eligibility:
Study pop:
Patients with immediate or advanced stage HCC who have been treated with regorafenib from
January 2018 to December 2021 following only one prior systemic therapy
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Patients with pathologically or clinically confirmed HCC;
2. Patients with Barcelona Clinic Liver Cancer (BCLC) stage B/C;
3. Patients previously treated with regorafenib for at least one 28-day cycle after
only one prior systemic therapy.
Exclusion Criteria:
1. Patients with incomplete information that would impact the assessment of primary
endpoint;
2. Patients with medical history of other malignant neoplasms.
Gender:
All
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Start date:
January 5, 2023
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Zhongda Hospital
Agency class:
Other
Collaborator:
Agency:
The Central Hospital of Lishui City
Agency class:
Other
Collaborator:
Agency:
Anhui Provincial Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Wuxi People's Hospital
Agency class:
Other
Collaborator:
Agency:
Jiangsu Cancer Institute & Hospital
Agency class:
Other
Collaborator:
Agency:
ZhuHai Hospital
Agency class:
Other
Source:
Zhongda Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557656
http://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf
