LBL-024 combined treatment for advanced biliary tract cancer and hepatocellular carcinoma.

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 open-label, multicenter Phase II study enrolls adults with advanced biliary tract cancer (BTC) or hepatocellular carcinoma (HCC) to receive LBL-024 combined with cisplatin, gemcitabine, and bevacizumab across two cohorts with safety run-ins. Each cohort begins with a small safety run-in period of 21 days to confirm tolerability before broader enrollment, and the trial plans to enroll up to 140 subjects. The study measures tumor response by RECIST 1.1 and monitors safety with routine laboratory and clinical assessments. Eligible patients generally have ECOG 0–1, at least one measurable lesion, and adequate organ and bone marrow function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
2. Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
4. The expected survival time is at least 12 weeks.
5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
6. There is adequate organ and bone marrow function,Conforms to laboratory test results.
7. Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug.

Exclusion Criteria:

1. Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or Subject is expected to receive any other form of systemic or local anti-tumor therapy outside the protocol during the study.
2. Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
3. Patients with active infection and requiring intravenous anti-infective therapy within 2 weeks before the first dose.
4. Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
5. The patient has a Medical history of immunodeficiency, including HIV antibody positive.
6. Women during pregnancy or lactation.
7. History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism or drug addiction.
8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Where it's running

• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• Henan Cancer Hospital
  Zhengzhou, Henan, China Recruiting
• Xiangyang Central Hospital
  Xiangyang, Hubei, China Recruiting
• Jiangxi Cancer Hospital
  Nanchang, Jiangxi, China Recruiting
• Shandong Cancer Hospital
  Jinan, Shandong, China Recruiting
• Zhongshan Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Jian zhou — Shanghai Zhongshan Hospital
• Study coordinator: Jian zhou
• Email: maxy@leadsbiolabs.com
• Phone: 021-64041990

Similar studies

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

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• LBL-024 combined with chemotherapy and immunotherapy for advanced gastric or gastroesophageal junction adenocarcinoma

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• LBL-024 combination treatment for advanced esophageal squamous cell carcinoma (Phase II, Substudy 03)

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• LBL-024 combination therapy for advanced non-small cell lung cancer (NSCLC)

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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.