NCT05954897RecruitingPhase 2
Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma
Lenvatinib, Tislelizumab Combined With RALOX Regimen HAIC in Advanced Hepatocellular Carcinoma: a Phase II, Single-arm, Prospective Study
Source: ClinicalTrials.gov · Last updated 20 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the efficacy and safety of lenvatinib, tislelizumab combined with RALOX regimen HAIC in advanced hepatocellular carcinoma.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- First submitted
- 12 Jul 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Guangdong Provincial People's Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05954897
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 29
- From 1 Sept 2023 to the primary completion date, 1 Jan 2026
- 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
- Previous liver transplantation;
- Previous history of severe mental illness;
- Active bleeding or coagulation abnormalities, bleeding tendency or receiving thrombolytic, anticoagulant or antiplatelet therapy;
Other illness
- History of other malignancies;
- Uncontrollable hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion or pericardial effusion;
Other
- Pathologically confirmed diagnosis of fibrolamellar HCC, sarcomatoid HCC, hepatocellular carcinoma-intrahepatic cholangiocarcinoma (HCC-ICC) mixed type;
- Other reasons were judged by the investigator to be unable to enroll.
Who the study is looking for
- 18 years or older.
- HCC was diagnosed according to the Criteria for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) and American Association for the Study of Liver Diseases (AASLD) criteria.
- Classified as stage C according to the Barcelona Clinic Liver Cancer (BCLC) staging system.
- A dominant mass in theliver with or without extrahepatic oligometastasis, which was defined as up to three metastatic lesions in up to two organs with the largest diameter of≤3 cm.
- No prior treatment for HCC.
- At least one measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST).
- Performance status (PS) ECOG score ≤1.
- Child-Pugh score ≤7.
- Subjects voluntarily participate in this study, and sign the informed consent form, cooperate with the follow-up
- Adequate organ function, defined as: Hb ≥ 90 g/dL; Neu ≥ 1.5 x 10 \^ 9/L; PLT ≥ 75 x 10 \^ 9/L; ALB ≥2.8 g/dL; TBIL ≤2 times the upper limit of normal; AST and ALT ≤ 3 times the upper limit of normal; Cre ≤1.5 x upper limit of normal; APTT≤1.5 times the upper limit of normal.
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.