Tislelizumab for Liver Cancer

Recruiting at 2 trial locations

Overseen By Salma Jabbour, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Suppressive therapy

Must not be taking: Immunotherapy, Corticosteroids, Antibiotics, others

Disqualifiers: HIV, Immunodeficiency, Metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Tislelizumab, a promising treatment for liver cancer, specifically advanced hepatocellular carcinoma (HCC). Researchers believe that using Tislelizumab after local therapies like radiation could better control the cancer and prevent its spread. Individuals with a confirmed HCC diagnosis who have not yet received systemic therapy and are candidates for radiation may be suitable for this trial. The goal is to determine if this combination can improve the chances of being cancer-free for one year. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain treatments like immunotherapy or herbal medicines for cancer, you may need to stop those before starting the trial.

Is there any evidence suggesting that Tislelizumab is likely to be safe for humans?

Research has shown that Tislelizumab is generally safe for people with liver cancer, often causing fewer side effects than sorafenib. One study used Tislelizumab with other treatments and reported good results without major safety issues. Another study found that using Tislelizumab alone or with other drugs can prolong the period before cancer returns in high-risk patients. Overall, these findings suggest Tislelizumab is a safe treatment option for liver cancer, with most patients tolerating it well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for liver cancer?

Researchers are excited about Tislelizumab for liver cancer because it targets the PD-1 pathway, which is a bit like flipping a switch to help the immune system recognize and attack cancer cells more effectively. This is different from traditional treatments like chemotherapy or transarterial chemoembolization (TACE), which directly attack cancer cells but can also harm healthy cells. By combining Tislelizumab with radiation therapy, there's potential for a powerful one-two punch: the immune system gets a boost to specifically target the cancer, while radiation helps shrink tumors. This approach could lead to better outcomes with fewer side effects.

What evidence suggests that Tislelizumab might be an effective treatment for liver cancer?

Research has shown that Tislelizumab holds promise for treating advanced liver cancer, also known as hepatocellular carcinoma (HCC). Studies have found that Tislelizumab can extend the lives of patients with advanced HCC and slow the cancer's progression. In this trial, participants will receive Tislelizumab alongside radiation therapy. While previous studies have explored combinations such as Tislelizumab with Lenvatinib, this trial specifically examines its combination with radiation therapy. Tislelizumab is considered a viable option for patients with advanced liver cancer, especially when other treatments may not be effective. Overall, early findings suggest that Tislelizumab aids the body's immune system in fighting cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Salma Jabbour, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for adults with advanced inoperable liver cancer (HCC) who haven't had systemic therapy but may have had TACE. They should be treatment-ready, without severe liver impairment (Child-Pugh A or B7), and no spread of cancer outside the liver. Participants need good organ function, manageable pain levels, a life expectancy over six months, and must agree to use effective birth control.

Inclusion Criteria

Demonstrate adequate bone marrow and organ function as defined below: Hematologic - Absolute neutrophil count (ANC) ≥ 1,500/mcL, Hemoglobin > 8.5 g/dL, Platelet count ≥ 75,000/mcL; Renal - Serum creatinine OR calculated* serum creatinine clearance (GFR can be used in place of creatinine or creatinine clearance) ≤ 1.5x upper limit of normal (ULN) OR ≥ 30 mL/min for participants with creatinine levels > 1.5x institutional ULN; Urine protein Urine dipstick for proteinuria < 2+ within 7 days prior to start of study treatment *Participants with ≥ 2+ proteinuria on dipstick analysis at baseline should undergo a 24-hour urine collection which must demonstrate < 1g of protein in 24 hours; Hepatic - Serum total bilirubin ≤ 3 mg/dL, AST (SGOT) and ALT (SGPT) ≤ 5x ULN, Alkaline phosphatase (ALP) ≤ 8x ULN Coagulation - International Normalized Ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 2.0x ULN *This applies only to participants not receiving therapeutic anticoagulation; participants receiving therapeutic anticoagulation should be on a stable dose

Written informed consent

Must have 1 target lesion measurable in 1 dimension according to RECIST 1.1

Exclusion Criteria

I have a skin condition like eczema or psoriasis, but it affects less than 10% of my body and is well-controlled with mild creams.

I have had recent serious heart or stroke issues.

Participants with clinically meaningful encephalopathy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Local Therapy

Participants receive local therapy including TACE+ RT or Ablation + RT or RT alone

4-6 weeks

2-3 visits (in-person)

Tislelizumab Treatment

Participants receive Tislelizumab before and after radiation therapy

48 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Tislelizumab

Trial Overview The study tests if Tislelizumab can improve survival rates when given after local treatments like radiation for HCC. It aims to see if this drug helps control the disease locally and fights off tiny undetected spreads of cancer.

How Is the Trial Designed?

Group I: Tislelizumab in conjunction with radiation therapy Experimental Treatment 1 Intervention

Participants will receive local therapy including TACE+ RT or Ablation (tumors with incomplete ablation) + RT or RT alone (for patients not eligible for TACE or Ablation) and will be screened for eligibility prior to enrollment. Once eligibility has been confirmed, Tislelizumab will be started before radiation therapy and will continue after radiation therapy. Participants who do not receive Tislelizumab for a total of two cycles will be replaced and interpreted for only toxicity analysis.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

BioGene Pharmaceutical Ltd.

Industry Sponsor

Trials

2

Recruited

40+

Natera, Inc.

Industry Sponsor

Trials

56

Recruited

50,700+

Published Research Related to This Trial

Tislelizumab is a modified PD-1 antibody that effectively inhibits tumor growth in various cancers, including Hodgkin's lymphoma and lung cancer, and has received multiple approvals in China for its use.

It has a favorable safety profile with common side effects like fatigue and anemia, and it offers economic advantages over other PD-1 inhibitors, making it a promising option for cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab: A Modified Anti-tumor Programmed Death Receptor 1 Antibody. Zhang, L., Geng, Z., Hao, B., et al.[2023]

Tislelizumab, an anti-PD-1 monoclonal antibody, shows improved progression-free survival and objective response rates in treating non-small cell lung cancer (NSCLC), especially when combined with chemotherapy, based on a review of four randomized controlled trials involving 1565 patients.

While tislelizumab is generally effective, it is associated with treatment-emergent adverse events, including significant hematologic issues and immune-mediated effects like hypothyroidism and pneumonitis, with a mortality rate from these events ranging from 3.2% to 4.2%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of tislelizumab, alone or in combination with chemotherapy, for the treatment of non-small cell lung cancer: a systematic review of clinical trials. Daei Sorkhabi, A., ZareDini, M., Fazlollahi, A., et al.[2023]

In a phase II study with 70 patients suffering from relapsed/refractory classical Hodgkin lymphoma, tislelizumab showed a high overall response rate of 87.1% and a complete response rate of 67.1% after a median follow-up of 33.8 months, indicating its efficacy as a treatment option.

The treatment demonstrated a favorable safety profile, with 97.1% of patients experiencing treatment-related adverse events, but only 31.4% having severe (grade ≥3) events, and just 8.6% discontinuing treatment due to adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab for Relapsed/Refractory Classical Hodgkin Lymphoma: 3-Year Follow-up and Correlative Biomarker Analysis. Song, Y., Gao, Q., Zhang, H., et al.[2023]

Tislelizumab, a PD-1 inhibitor, significantly improved the overall response rate (ORR) and disease control rate (DCR) in patients with malignant solid tumors, with odds ratios of 2.59 and 1.78, respectively, based on a meta-analysis of seven phase III trials involving 3478 participants.

The treatment also demonstrated improved overall survival (OS) and progression-free survival (PFS), with hazard ratios of 0.71 and 0.68, indicating that tislelizumab is an effective option for patients with solid tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tislelizumab for malignant solid tumor: a systematic review and meta-analysis of phase III randomized trials. Abushanab, AK., Mustafa, MT., Mousa, MT., et al.[2023]

In a phase 2 study involving 249 patients with previously treated advanced hepatocellular carcinoma (HCC), tislelizumab showed an objective response rate of 13%, indicating its potential effectiveness as a treatment option.

The treatment was generally well-tolerated, with only 15% of patients experiencing grade ≥3 treatment-related adverse events, and no deaths attributed to the treatment, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab in Patients with Previously Treated Advanced Hepatocellular Carcinoma (RATIONALE-208): A Multicenter, Non-Randomized, Open-Label, Phase 2 Trial. Ren, Z., Ducreux, M., Abou-Alfa, GK., et al.[2023]

In a phase 3 clinical trial with 674 patients, tislelizumab showed noninferior overall survival compared to sorafenib for first-line treatment of unresectable hepatocellular carcinoma (HCC), with median survival times of 15.9 months versus 14.1 months, respectively.

Tislelizumab had a higher objective response rate (14.3% vs 5.4%) and a more durable response duration (36.1 months vs 11.0 months) compared to sorafenib, while also demonstrating a better safety profile with fewer severe adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tislelizumab vs Sorafenib as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase 3 Randomized Clinical Trial. Qin, S., Kudo, M., Meyer, T., et al.[2023]

Tislelizumab, a monoclonal antibody targeting PD-1, shows promising preliminary antitumor activity in patients with advanced unresectable hepatocellular carcinoma (HCC), which typically has a poor prognosis with a median life expectancy of about 1 year.

This study is a Phase III trial that directly compares the efficacy, safety, and tolerability of tislelizumab against sorafenib, a standard treatment for unresectable HCC, aiming to establish tislelizumab as a viable first-line therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RATIONALE 301 study: tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma. Qin, S., Finn, RS., Kudo, M., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12488645/

Efficacy of Tislelizumab plus Lenvatinib in hepatocellular ... In a global, open-label phase 3 study (IMbrave050), improved recurrence-free survival was observed in high-risk hepatocellular carcinoma ...

2. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14092-1

Comparative efficacy of tislelizumab plus lenvatinib and ... The combination of tislelizumab and lenvatinib was well tolerated and associated with improved OS and PFS versus tislelizumab alone for patients with advanced ...

3. cureus.com cureus.com/articles/367689-efficacy-and-safety-of-tislelizumab-as-an-immune-checkpoint-inhibitor-for-the-treatment-of-advanced-hepatocellular-carcinoma-a-systematic-review-and-meta-analysis.pdf

Efficacy and Safety of Tislelizumab as an Immune ... These findings support tislelizumab as a viable immunotherapeutic option for advanced HCC, warranting further exploration in larger, randomized ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1590865825009284

A multicentric national phase II trial assessing TIslelizumab ... Liver dysfunction impacts survival and may influence treatment results. About a quarter of patients with advanced HCC present with Child-Pugh B liver functions.

5. actr.amegroups.org actr.amegroups.org/article/view/10247/html

Tislelizumab in hepatocellular carcinoma: a duet or a solo ... The survival rate at 36 months was 29.2% for patients in tislelizumab arm. Of note, based on the curves provided in the article, more than 20% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12335811/

Efficacy and Safety of Tislelizumab as an Immune Checkpoint ... Clinically, these results suggest that tislelizumab can extend survival in HCC patients by over a year, offering a compelling treatment option ...

7. nature.com nature.com/articles/s41598-025-20518-4

The efficacy and safety analysis of D-TACE combined with ... The D-TACE + Donafenib + Tislelizumab group demonstrated significantly higher objective response rate (62.7% vs. 40.7%, P < 0.05) and disease ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40752979/

A multicentric national phase II trial assessing TIslelizumab ... Liver dysfunction impacts survival and may influence treatment results. About a quarter of patients with advanced HCC present with Child-Pugh B ...

9. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1593153/full

The efficacy and safety of tislelizumab with or without ... This study suggests that tislelizumab alone or in combination with TKIs can significantly extend the RFS of HCC patients at high risk of ...