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

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 02(BTC&HCC)]

This study tests whether LBL-024 given with chemotherapy and bevacizumab helps adults with advanced biliary tract cancer or hepatocellular carcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (Industry-sponsored)
• Locations: 6 sites (Zhengzhou, Henan and 5 other locations)
• Trial ID: NCT07111546 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–75 with advanced BTC or HCC, ECOG performance status 0–1, at least one measurable lesion, adequate organ and bone marrow function, and willingness to use effective contraception are the intended participants.

Not a fit: Patients with poor performance status, short expected survival, inadequate organ or bone marrow function, no measurable disease, or recent participation in other antineoplastic trials are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the combination could shrink tumors, slow disease progression, and extend the time patients live without their cancer worsening.

How similar studies have performed: Standard gemcitabine/cisplatin chemotherapy and anti-VEGF approaches have shown activity in BTC and HCC contexts, but LBL-024 is a novel agent and this specific combination regimen is largely untested.

Eligibility criteria

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 this trial is running

Zhengzhou, Henan and 5 other locations

• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (Recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)
• Zhongshan Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• Sir Run Run Shaw Hospital (SRRSH) Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jian zhou — Shanghai Zhongshan Hospital
• Study coordinator: Jian zhou

Conditions Advanced Solid Tumour