LBL-024 for InjectionCisplatin InjectionGemcitabine Hydrochloride for InjectionBevacizumab Injection
LBL-024 for Injection: Intravenous infusion.
Cisplatin Injection: Intravenous infusion.
Gemcitabine Hydrochloride for Injection: Intravenous infusion.
Bevacizumab Injection: Intravenous infusion.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Objective Response Rate (ORR) — From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.
Trial sites (13)
Facility
City
Region
Status
Anhui Provincial Hospital
Hefei
Anhui
Not Yet Recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou
Fujian
Not Yet Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning
Guangxi
Not Yet Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
Xiangyang Central Hospital
Xiangyang
Hubei
Recruiting
People's Hospital of Hunan Province
Changsha
Hunan
Not Yet Recruiting
Jiangxi Cancer Hospital
Nanchang
Jiangxi
Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Recruiting
Zhongshan Hospital of Fudan University
Shanghai
Shanghai Municipality
Recruiting
Xi 'an International Medical Center Hospital
Xi’an
Shanxi
Not Yet Recruiting
Sichuan Cancer Hospital
Chengdu
Sichuan
Not Yet Recruiting
Sir Run Run Shaw Hospital (SRRSH) Zhejiang University School of Medicine
Hangzhou
Zhejiang
Recruiting
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
Recruiting
More Nanjing Leads Biolabs Co.,Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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