Study on Tislelizumab After Liver-Directed Therapy for Liver Cancer
Sponsor: Rutgers, The State University of New Jersey
ClinicalTrials ID:NCT05366829
This clinical trial is exploring whether adding Tislelizumab after local treatments for advanced liver cancer can help control the disease and improve survival rates. The study aims to see if this approach can prevent cancer from progressing and enhance local control of the tumor.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study is investigating if using Tislelizumab after local treatments for advanced liver cancer that cannot be surgically removed can help stop the cancer from getting worse for at least a year. Researchers believe that Tislelizumab might work well with local treatments and also target small cancer cells that have spread, potentially improving survival rates and controlling the cancer more effectively.
Description
The main goal of this study is to find out if Tislelizumab, given after local treatments, can help patients with advanced liver cancer live longer without the cancer getting worse. This is called progression-free survival. The study will also look at whether this treatment can delay the spread of cancer to other parts of the body and improve overall survival.
Other goals include:
- Checking how well the cancer responds to the treatment and how long the response lasts.
- Evaluating the safety of Tislelizumab after local treatments.
- Measuring changes in a protein called Alpha fetoprotein (AFP) that some liver tumors produce.
The study will also explore:
- How the genetic makeup of the tumor might affect the response to treatment.
- Using circulating tumor DNA as a marker to track treatment response and early signs of cancer progression.
Eligibility Criteria
Inclusion Criteria
- Must provide written consent to participate.
- Diagnosed with liver cancer and planned to receive radiation; no prior systemic therapy for liver cancer, but previous TACE is allowed.
- Diagnosis confirmed by tissue sample or specific imaging criteria.
- Good overall health with a performance status score of 0-2.
- Aged 18 years or older.
- Liver function classified as Child-Pugh class A or B7, and not suitable for surgery or liver transplant.
- No cancer spread outside the liver as confirmed by specific scans.
- Women of childbearing age must use effective birth control during the study and for 6 months after the last dose of Tislelizumab, and have a negative pregnancy test before starting the study.
- Men must use effective birth control during the study and for 6 months after the last dose, and agree not to donate sperm during this time.
- Must have at least one measurable tumor according to specific criteria.
- Must have adequate blood cell counts and organ function as determined by specific tests.
Exclusion Criteria
- Previous radiation to the liver that would overlap with new treatment areas.
- Previous specific liver-directed therapies.
- Severe active health conditions as determined by the investigator.
- More than five distinct liver cancer spots or major blood vessel involvement.
- Cancer spread to the stomach, intestines, or major bile ducts.
- Cancer spread outside the liver or large malignant lymph nodes.
- Previous liver transplant.
- HIV positive or requiring long-term immune system therapy.
- Previous immunotherapy.
- Significant fluid buildup in the abdomen requiring non-drug treatment.
- Significant brain function issues.
- Previous organ or bone marrow transplant, except for kidney transplant patients who can use dialysis if needed.
- Active hepatitis B with high viral load unless controlled with medication.
- Co-infection with hepatitis B and C.
- History of hepatitis C but currently virus-free can participate.
- History of autoimmune thyroid disease or controlled Type 1 diabetes can participate.
- Skin conditions like eczema or psoriasis are allowed if mild and controlled.
- Any cancer within 5 years except for specific treated cancers.
- Recent live vaccines not allowed, except for inactivated flu and COVID-19 vaccines.
- Recent use of high-dose steroids or other immune-suppressing drugs.
- Uncontrolled diabetes or significant electrolyte imbalances.
- History of lung diseases or severe infections.
- Recent major surgery or cardiovascular events.
- Use of herbal cancer treatments recently.
- Unresolved side effects from previous cancer treatments.
- Other medical conditions or substance abuse that could interfere with the study.
- Participation in another clinical trial.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | 08903 | New Brunswick | New Jersey |
| Montefiore Medical Center | 10451 | Bronx | New York |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.