Collecting data on treatment effectiveness and safety for patients with advanced liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather data on the efficacy and safety of transarterial chemoembolization (TACE) combined with targeted or immunotherapy in patients with unresectable hepatocellular carcinoma. It focuses on patients who have not received prior treatment or those who have experienced recurrence after radical therapy. The study will assess the impact of these treatment combinations on patient outcomes, including overall survival and progression-free survival. By analyzing the collected data, the study seeks to identify the most effective treatment strategies for this challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1, age 18-75 years old; 2. Patients with primary unresectable liver cancer who have not received any previous treatment (in accordance with the AASLD 2018/EASL 2018 Liver Cancer Diagnostic guidelines); Or patients with unresectable liver cancer who recurred for the first time after radical therapy and did not receive any postoperative adjuvant therapy; 3. There is at least one lesion in the liver that can be measured according to mRECIST criteria, and the intrahepatic lesion is a single tumor ≤10.0cm or multiple tumors (the number of tumors ≤10) and the tumor load is less than 50% (three-dimensional reconstruction of CT scan using Vitelacore software \[version: 6.9.87.1, Canon\], calculated as proportion of tumor volume to total liver volume) 4. Normal liver tissue volume exceeds 700ml 5, ECOG score 0-1, good general condition 6, liver function Child-Pugh grade A 7. Expected survival time ≥3 months 8. Blood, liver and kidney function meet the following conditions: a) Neutrophil count ≥1.5×109/L b) Platelet count ≥60×109/L c) Hemoglobin concentration ≥90g/L d) Serum albumin concentration ≥30g/L e) bilirubin ≤50umol/L f) AST and ALT were 5 times lower than the upper limit of normal, ALP less than 4 times the upper limit of normal g) prothrombin time less than 6 seconds above the upper limit of normal h) creatinine less than 1.5 times the upper limit of normal

Exclusion Criteria:

1. Preoperative imaging examination assessed tumor load \>50%;
2. Previous history of hepatic encephalopathy, refractory ascites, or esophageal and gastric varices rupture bleeding;
3. There are contraindications for TACE treatment, such as portal shunt, isolated hepatic blood flow, and obvious atherosclerosis;
4. Patients with extrahepatic metastasis;
5. Allergic to intravenous contrast agents;
6. Pregnant or lactating women or subjects who plan to have a family within two years; 7, accompanied by HIV, syphilis infection;

8\. Accompanied by other malignant tumors or had other malignant tumors within 5 years prior to enrollment; 9. Allogeneic organ transplants; 10, serious heart, kidney and other organ dysfunction; 11. Active clinical severe infection \> Grade 2; 12. Suffering from mental illness may affect informed consent; 13, can not take oral medicine; 14. Participated in other drug clinical trials within 12 months before enrollment; 15. Active gastric or duodenal ulcer occurred 3 months before enrollment; 16. Previous history of liver or adjacent tissue radiotherapy

Where it's running

• The First Affiiated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Zhenwei Peg, Dr.
• Email: pzhenw@mail.sysu.edu.cn
• Phone: 86+18620565282

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining TACE with Camrelizumab and Apatinib for Liver Cancer

  This study is testing if combining a liver cancer treatment called TACE with two drugs, camrelizumab and apatinib, can help people with advanced liver cancer live longer and feel better compared to standard treatments.

  Recruiting Phase 3 Sichuan Cancer Hospital and Research Institute · Chengdu, Sichuan · NCT06485466

• First-line combo therapy with anlotinib, benmelstobart, and HAIC for unresectable HCC

  This study tests whether adding benmelstobart and hepatic arterial infusion chemotherapy to anlotinib can help people with unresectable hepatocellular carcinoma respond to treatment as a first line.

  Recruiting Phase 2 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07806292

• First-Line Nivolumab plus Ipilimumab in unresectable hepatocellular carcinoma

  This study tests whether the combination of nivolumab and ipilimumab is safe and effective for adults with unresectable liver cancer in real-world care in Japan.

  Recruiting at 2 sites Bristol-Myers Squibb · Minato-ku, Tokyo and 1 other locations · NCT07679061

• Omitting brain metastasis radiation after tumor removal when CNS-active therapy is used

  This pilot study tests whether patients with resected brain metastases from melanoma or NSCLC can skip post-operative brain radiation while receiving CNS-active systemic therapy.

  Recruiting Phase 1 M.D. Anderson Cancer Center · Houston, Texas · NCT07655583

• Y90 liver radiation plus immunotherapy and targeted drug for unresectable liver cancer

  This test will see if adding Y90 liver radiation to nivolumab, ipilimumab, and lenvatinib helps people with unresectable hepatocellular carcinoma live longer and have better tumor responses.

  Recruiting Phase 1/2 West China Hospital · Chengdu, Sichuan · NCT07482059

• Adjuvant TACE after curative liver cancer surgery for patients with high-risk recurrence features

  This trial will see if giving TACE after curative liver surgery lowers the chance the cancer comes back in people who have high-risk features for recurrence.

  Recruiting Phase 3 Guangxi Medical University · Nanning · NCT07417397

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.