Phase II study of pembrolizumab in advanced hepatocellular carcinoma as second-line treatment after failure of sorafenib: integration of genomic analysis to identify predictive molecular subtypes
- Conditions
- Neoplasms
- Registration Number
- KCT0003293
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1. Test subjects with the intent and ability to provide written consent/approval for this clinical trial. The test subjects may also provide consent for biomedical research. However, test subjects may participate in state clinical trials without participating in biomedical studies.
2. Test subjects with an age of 20 or older at the time of signing the consent of the test subjects (or the higher of acceptable age according to local regulations).
3. Organically or cytologically verified HCC diagnosis based on pathology report (fiber plateability and mixed liver cell/tibial cancer subtype are not suitable)
4. Barca Clinical Liver Cancer (BCLC) Test subjects with C-level disease, or BCLC B-stage disease that cannot be treated with local therapy or that cannot be treated with local treatment and cannot be treated with near-sighted treatment
5. Test target corresponding to the score between Grade A Child-Pugh
6. Test subjects that record the progress of an objective radiation or clinical disease during the primary sorafenib therapy.
7. Test subjects with lesions that can be measured based on mRECIST according to the tester's assessment. Tumor lesions located in previously irradiated areas are considered measurable if progress is confirmed on these lesions.
a. NOTE: Exactly the same image acquisition and processing parameters should be used throughout the clinical trial.
8. Test subjects willing to provide fresh tissue based on the adequacy of tissue sample quality for biometric analysis and for evaluation of biometric conditions. Repetitive samples may be required if appropriate tissue is not provided. They prefer newly acquired endoscopic biopsy samples rather than storage samples, and prefer formalin-fixed and paraffin-possession (FFPE) block samples to slides.
. Newly acquired samples are defined as samples obtained up to 12 weeks (84 days) prior to commencement of treatment on the first day. Test subjects may submit storage samples for which the newly acquired samples cannot be provided (e.g. inaccessible or safety concerns of the test subjects).
b. In addition, a collection of preserved tissue samples is required to support the evaluation of the clinical usefulness of bioclammatic assessment on newly acquired vs. (if possible);
9. Test subjects with status 0 or 1 on the ECOG performance scale.
10. Test subjects with non-viral HCC or HBV-HCC as defined below are eligible for registration:
i) HBV-HCC: Resolved HBV infections (detected HBV surface antibodies, detectable HBV central antibodies, non-detectable HBV DNA, and non-detectable HBV surface antigen)
The test subjects for chronic HBV infection must be HBV DNA < 100 IU/mL, and antiviral therapy must be administered.
ii) HCV-HCC: Activity or resolved HCV infections identified by detectable HCV RNA or antibodies.
11. Test subjects whose long-term capability is appropriately demonstrated as defined in Table 1. All screening clinical laboratory examinations are conducted within 10 days prior to commencement of treatment.
12. Female test subjects shall have a urine or serum pregnancy test voice within 72 hours prior to administration of the initial dose of the test drug. If the urine test is positive or negative, a serum pregnancy test is required.
13. Female test subjects (Chapter 5.7.2) must be willing to use appropriate contraception methods during the clinical trial process and until 120 days after final administration of the test drug – as described in Chapter 5.7.2 – Controlled.14.
1. Currently participating in clinical trials and receiving clinical trial therapy, or participating in a clinical trial within four weeks prior to the initial administration of clinical trial treatments, or using clinical testing devices.
2. The test subjects who received the sorafenib within 14 days of the initial administration of the drug.
3. Test subjects with esophagus or gastric varicose veins within the last 6 months. If no screening of esophageal varicose veins has been performed within 12 months prior to the initial administration of the treatment, all test subjects are screened for esophagus varicose veins. If varicose veins exist, they should be treated in accordance with the testing agency standards before clinical trial treatment begins.
4. Test subjects with solid organ transplants.
5. Test subjects with active autoimmune disease who have treated the body in the past two years (i.e., using disease control agents, corticosteroid or immunosuppressant). Alternative therapies (e.g., physiological corticosteroid replacement therapy for Tiroxin, insulin or adrenal or pituitary failure) are not considered to be types of full-body care.
6. Test subjects diagnosed with immunodeficiency or administered full-body steroids or other types of immunosuppression therapy within seven days prior to the initial administration of clinical trial treatments.
7. Local therapy for within four weeks prior to initial administration of a test medication (TCEE, colorimetric embolism for hardness tube [TATE], radiation therapy, radiation embolism, or ablation) Decimal treatments (e.g., simple ablation, foot control) were performed at least seven days prior to the initial administration of clinical trial treatments (1 cycle, 1 day).
. Persons tested for additional malignant tumors that are currently in progress or require active treatment. Exceptions include skin basal cell carcinoma or skin flat cell cancer or cervical cervical cervical endodermal cancer, which has been treated with potential full-treatment.
8.Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
9. The active central nervous system (CNS) transfer and/or cancer meningitis are known to be tested. Test subjects with previously treated brain transitions are stable (if they are not used for at least four weeks prior to the initial administration of clinical trial treatments, there is no evidence of at least seven weeks of progress by video, and no evidence of new or extended brain transfer). Exceptions include cancerous meningitis, which excludes clinical stability.
10. Test subjects with known or substantiated past history of epilepsy lung disease or active, non-inflammatory pneumonia.
11. Test subjects with active infections that require full body care.
12. The history or current evidence of any condition, therapy or clinical laboratory abnormalities in which the treatment tester determines confuses clinical test results, interferes with testing participants' participation during the entire clinical trial period, or does not provide the best benefit.
13. Persons who are tested for mental or substance abuse that may interfere with cooperation in clinical testing requirements.
14. A person who is pregnant or breastfeeding, or who plans to become pregnant or father of a child within the ex
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate
- Secondary Outcome Measures
Name Time Method Biological marker (prospective storage of plasma for ctDNA)