NCT07064668Not yet recruitingPhase 2
Tauroursodeoxycholic Acid Combined With PD-1/PD-L1 Immunotherapy in Advanced Hepatocellular Carcinoma: A Prospective Study
Prospective Study on the Synergistic Effect of Tauroursodeoxycholic Acid Combined With Immunotherapy in Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 15 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a clinical trial that aims to evaluate whether adding a bile acid called tauroursodeoxycholic acid (TUDCA) can improve the effects of immunotherapy in patients with advanced liver cancer (hepatocellular carcinoma). Immunotherapy has shown promise in treating this type of cancer, but not all patients respond well. TUDCA is known to help protect liver cells and may improve the liver's immune environment, potentially making immunotherapy more effective. In this study, 300 patients with advanced liver cancer will be randomly assigned to receive either immunotherapy alone or immunotherapy combined with TUDCA. Researchers will look at how well the cancer responds, whether the treatment helps more patients become eligible for surgery, and how safe the combination is. The goal is to find a more effective and better tolerated treatment for patients with liver cancer.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 5 Jul 2025
- Start date
- 30 Jul 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Tongji Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07064668
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 300
- From 30 Jul 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a previous diagnosis of biliary atresia without adequate biliary drainage (e.g., failed biliary-enteric anastomosis).
Other illness
- History of hepatic encephalopathy or liver transplantation.
- Patients with Child-Pugh class C or decompensated cirrhosis, including those with a history of severe hepatic encephalopathy or refractory ascites due to liver disease.
Other
- Acute cholecystitis, acute cholangitis, patients with frequent biliary colic attacks, complete biliary obstruction, or gallbladder dysfunction (inability to contract and empty).
- Pregnant or breastfeeding women.
Who the study is looking for
- Histologically or cytologically confirmed diagnosis of primary hepatocellular carcinoma (HCC).
- Unresectable advanced HCC classified as Barcelona Clinic Liver Cancer (BCLC) stage C.
- Age ≥ 18 years.
- No prior systemic anti-tumor therapy for HCC before first dose of study treatment.
- At least one measurable lesion according to RECIST v1.1, or a measurable lesion with clear progression after local treatment based on RECIST v1.1.
- Adequate organ and bone marrow function within 7 days prior to enrollment, with no blood products, growth factors, albumin, or other intravenous/subcutaneous corrective treatment within 14 days prior to laboratory assessment:
- Hematology:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelet count (PLT) ≥ 75 × 10⁹/L Hemoglobin (Hb) ≥ 9.0 g/dL
- Liver function:
- Total bilirubin (TBil) ≤ 2 × ULN ALT and AST ≤ 5 × ULN Serum albumin ≥ 28 g/L
- Alkaline phosphatase (ALP) ≤ 5 × ULN
- Renal function:
- Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min (calculated by Cockcroft-Gault formula) Urinalysis shows urine protein \< 2+; if urine protein ≥ 2+, 24-hour urine collection must show protein \< 1g/24h
- Coagulation:
- International Normalized Ratio (INR) ≤ 2.3 or prothrombin time (PT) prolongation ≤ 6 seconds
- Estimated life expectancy of ≥ 12 weeks.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Medical college of HUST Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.