LBL-024 for InjectionCapecitabine tabletsTislelizumab InjectionOxaliplatin injection
LBL-024 for Injection: Intravenous infusion
Capecitabine tablets: Oral administration
Tislelizumab Injection: Intravenous infusion
Oxaliplatin 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
—
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 years at the time of signing the informed consent.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 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. Patients with histologically confirmed unresectable locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma.
7. There is adequate organ and bone marrow function,Conforms to laboratory test results.
8. 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 (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets,etc); Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.
Exclusion Criteria:
1. Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or is expected to receive any other form of systemic 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, or who have had and have the possibility of recurrence of autoimmune diseases.
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. Active hepatitis B or active hepatitis C.
7. Women during pregnancy or lactation.
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 (7)
Facility
City
Region
Status
Beijing GoBroad Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Not Yet Recruiting
Shandong Cancer Hospital
Jinan
Shandong
Not Yet Recruiting
The Affiliated Hospital of Qingdao University
Qingdao
Shandong
Not Yet Recruiting
Shanxi Provincial Cancer Hospital
Taiyuan
Shanxi
Not Yet Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tianjin Municipality
Not Yet 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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