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

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 is an open-label, multicenter Phase II trial enrolling up to 110 adults with unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma. The study begins with a small safety run-in where a few patients receive the LBL-024 combination and are observed for 21 days for tolerability. If the combination is judged safe, the trial expands into a randomized, open-label comparison with participants assigned 2:1 to the experimental combination versus a positive control regimen. Key treatments include LBL-024 for injection given with capecitabine, oxaliplatin, and the PD-1 inhibitor tislelizumab, and outcomes will include safety and measures of tumor response.

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 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.

Where it's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing GoBroad Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• The Fourth Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Not yet recruiting
• Shandong Cancer Hospital
  Jinan, Shandong, China Not yet recruiting
• The Affiliated Hospital of Qingdao University
  Qingdao, Shandong, China Not yet recruiting
• Shanxi Provincial Cancer Hospital
  Taiyuan, Shanxi, China Not yet recruiting

Study contacts

• Principal investigator: Lin Shen — Peking University Cancer Hospital & Institute
• Study coordinator: Lin Shen
• Email: doctorshenlin@sina.cn
• Phone: 010-88121122

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

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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.